Trial Outcomes & Findings for Atrial Fibrillation Health Literacy and Information Technology Trial in Rural Pennsylvania Counties (NCT NCT04076020)
NCT ID: NCT04076020
Last Updated: 2024-05-30
Results Overview
Proportion of Days Covered (PDC), obtained from collection of electronic prescription and pharmacy fill data, and defined as the proportion of availability of medication for the period of interest. PDC range is 0 to 1.00 with higher values indicating greater proportion of days with medication as indicated by pharmacy records.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
270 participants
Primary outcome timeframe
12 months
Results posted on
2024-05-30
Participant Flow
Participants were recruited based on physician referral at numerous University of Pittsburgh Medical Center (UPMC) sites located in rural Pennsylvania counties. The first participant was enrolled on January 8th, 2020 and the last participant was enrolled in March 2022.
Participant milestones
| Measure |
Intervention: ECA/Kardia
Participants received the relational agent and the AliveCor Kardia to use for 120 days.
Participants were directed to use the relational agent and AliveCor Kardia daily.
Relational agent/AliveCor Kardia - Intervention Group: Use of the relational agent and Kardia daily for 120 days.
|
Control: WebMD
Participants received a brochure on atrial fibrillation that is published by the American Heart Association and a smartphone with the WebMD application.
Participants were directed to use the WebMD application as often as they would like.
Usual Care: Use of the WebMD app daily for 120 days.
|
|---|---|---|
|
Overall Study
STARTED
|
135
|
135
|
|
Overall Study
COMPLETED
|
119
|
121
|
|
Overall Study
NOT COMPLETED
|
16
|
14
|
Reasons for withdrawal
| Measure |
Intervention: ECA/Kardia
Participants received the relational agent and the AliveCor Kardia to use for 120 days.
Participants were directed to use the relational agent and AliveCor Kardia daily.
Relational agent/AliveCor Kardia - Intervention Group: Use of the relational agent and Kardia daily for 120 days.
|
Control: WebMD
Participants received a brochure on atrial fibrillation that is published by the American Heart Association and a smartphone with the WebMD application.
Participants were directed to use the WebMD application as often as they would like.
Usual Care: Use of the WebMD app daily for 120 days.
|
|---|---|---|
|
Overall Study
Death
|
4
|
6
|
|
Overall Study
Withdrawal by Subject
|
12
|
8
|
Baseline Characteristics
Atrial Fibrillation Health Literacy and Information Technology Trial in Rural Pennsylvania Counties
Baseline characteristics by cohort
| Measure |
Intervention Arm
n=135 Participants
Participants received the relational agent and the AliveCor Kardia to use for 120 days.
Participants were directed to use the relational agent and AliveCor Kardia daily.
Relational agent/AliveCor Kardia - Intervention Group: Use of the relational agent and Kardia daily for 120 days.
|
Usual Care Arm
n=135 Participants
Participants received a brochure on atrial fibrillation that is published by the American Heart Association and a smartphone with the WebMD application.
Participants were directed to use the WebMD application as often as they would like.
Usual Care: Use of the WebMD app daily for 120 days.
|
Total
n=270 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
73.6 years
n=5 Participants
|
72.7 years
n=7 Participants
|
73.1 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
80 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
163 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
131 Participants
n=5 Participants
|
130 Participants
n=7 Participants
|
261 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
129 Participants
n=5 Participants
|
128 Participants
n=7 Participants
|
257 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Anticoagulant medication used for stroke prevention
Warfarin
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Anticoagulant medication used for stroke prevention
Direct acting oral anticoagulant
|
113 Participants
n=5 Participants
|
113 Participants
n=7 Participants
|
226 Participants
n=5 Participants
|
|
Education
High school, vocational or trade school or less
|
70 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
|
Education
Some College or associate degree
|
39 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Education
College (Bachelors or higher)
|
26 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Employment Status
Currently Working, Part-time or Full-time
|
20 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Employment Status
Not Currently Working
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Employment Status
Retired
|
104 Participants
n=5 Participants
|
107 Participants
n=7 Participants
|
211 Participants
n=5 Participants
|
|
Marital Status
Single, not married
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Marital Status
Married or living as married
|
86 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
181 Participants
n=5 Participants
|
|
Marital Status
Separated or divorced
|
18 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Marital Status
Widowed
|
24 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Cohabitation
Resides with others
|
86 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
181 Participants
n=5 Participants
|
|
Cohabitation
Resides alone
|
49 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Housing
Renting
|
17 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Housing
Buying, and Paying mortgage
|
22 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Housing
Own
|
92 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
185 Participants
n=5 Participants
|
|
Housing
Neither own nor pay rent
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Housing
Prefer not to respond
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Housing ownership status
Ownership
|
92 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
185 Participants
n=5 Participants
|
|
Housing ownership status
Rent or other status
|
43 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Hypertension
Yes
|
117 Participants
n=5 Participants
|
117 Participants
n=7 Participants
|
234 Participants
n=5 Participants
|
|
Hypertension
No
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Smoking
Never Smoke
|
62 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
|
Smoking
Current Smoker
|
12 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Smoking
Past Smoker
|
61 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
|
Alcohol consumption, heavy
Yes
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Alcohol consumption, heavy
No
|
130 Participants
n=5 Participants
|
130 Participants
n=7 Participants
|
260 Participants
n=5 Participants
|
|
History of any cardioversion
Yes
|
43 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
History of any cardioversion
No
|
92 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
190 Participants
n=5 Participants
|
|
Electrical Cardioversion
Yes
|
40 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Electrical Cardioversion
No
|
95 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
195 Participants
n=5 Participants
|
|
Pharmacologic cardioversion
Yes
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Pharmacologic cardioversion
No
|
130 Participants
n=5 Participants
|
133 Participants
n=7 Participants
|
263 Participants
n=5 Participants
|
|
Health Literacy
Limited Health Literacy
|
63 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
|
Health Literacy
Adequate Health Literacy
|
72 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
145 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
32.8 kg/m^2
STANDARD_DEVIATION 8.1 • n=5 Participants
|
33.5 kg/m^2
STANDARD_DEVIATION 8.7 • n=7 Participants
|
33.1 kg/m^2
STANDARD_DEVIATION 8.4 • n=5 Participants
|
|
AF History
|
5.8 years
STANDARD_DEVIATION 6.7 • n=5 Participants
|
7.0 years
STANDARD_DEVIATION 8.7 • n=7 Participants
|
6.4 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
|
AF Effect on Quality-of-Life questionnaire (AFEQT)
Overall
|
75.1 units on a scale
STANDARD_DEVIATION 15.1 • n=5 Participants
|
73.7 units on a scale
STANDARD_DEVIATION 17.0 • n=7 Participants
|
74.4 units on a scale
STANDARD_DEVIATION 16.1 • n=5 Participants
|
|
AF Effect on Quality-of-Life questionnaire (AFEQT)
Symptoms
|
85.5 units on a scale
STANDARD_DEVIATION 15.0 • n=5 Participants
|
83.5 units on a scale
STANDARD_DEVIATION 17.1 • n=7 Participants
|
84.5 units on a scale
STANDARD_DEVIATION 16.1 • n=5 Participants
|
|
AF Effect on Quality-of-Life questionnaire (AFEQT)
Daily activities
|
66.0 units on a scale
STANDARD_DEVIATION 23.6 • n=5 Participants
|
67.1 units on a scale
STANDARD_DEVIATION 25.0 • n=7 Participants
|
66.6 units on a scale
STANDARD_DEVIATION 24.2 • n=5 Participants
|
|
AF Effect on Quality-of-Life questionnaire (AFEQT)
Treatment concern
|
80.4 units on a scale
STANDARD_DEVIATION 16.6 • n=5 Participants
|
76.1 units on a scale
STANDARD_DEVIATION 19.1 • n=7 Participants
|
78.2 units on a scale
STANDARD_DEVIATION 18.0 • n=5 Participants
|
|
AF Effect on Quality-of-Life questionnaire (AFEQT)
Treatment Satisfaction: How well treatment controls symptoms
|
82.6 units on a scale
STANDARD_DEVIATION 17.5 • n=5 Participants
|
79.0 units on a scale
STANDARD_DEVIATION 18.9 • n=7 Participants
|
80.8 units on a scale
STANDARD_DEVIATION 18.3 • n=5 Participants
|
|
AF Effect on Quality-of-Life questionnaire (AFEQT)
Treatment satisfaction: Relief of symptoms
|
81.0 units on a scale
STANDARD_DEVIATION 19.0 • n=5 Participants
|
77.7 units on a scale
STANDARD_DEVIATION 21.6 • n=7 Participants
|
79.3 units on a scale
STANDARD_DEVIATION 20.4 • n=5 Participants
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Physical function
|
41.7 units on a scale
n=5 Participants
|
42.9 units on a scale
n=7 Participants
|
41.8 units on a scale
n=5 Participants
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Depression and sadness
|
41.0 units on a scale
n=5 Participants
|
48.9 units on a scale
n=7 Participants
|
48.9 units on a scale
n=5 Participants
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Pain interference
|
53.9 units on a scale
n=5 Participants
|
55.7 units on a scale
n=7 Participants
|
54.8 units on a scale
n=5 Participants
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Satisfaction with participation in social roles and activities
|
53.9 units on a scale
n=5 Participants
|
55.7 units on a scale
n=7 Participants
|
54.8 units on a scale
n=5 Participants
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Fatigue
|
51.0 units on a scale
n=5 Participants
|
51.9 units on a scale
n=7 Participants
|
51.0 units on a scale
n=5 Participants
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Anxiety and fear
|
48.2 units on a scale
n=5 Participants
|
51.4 units on a scale
n=7 Participants
|
50.4 units on a scale
n=5 Participants
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Sleep disturbance
|
51.0 units on a scale
n=5 Participants
|
50.8 units on a scale
n=7 Participants
|
51.0 units on a scale
n=5 Participants
|
|
Self-reported adherence
Adherent
|
120 Participants
n=5 Participants
|
119 Participants
n=7 Participants
|
239 Participants
n=5 Participants
|
|
Self-reported adherence
Non-adherent
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Initial data set included 270 participants. 7 cases of no pharmacy data, 12 cases with start date after end date, and 1 case where one fill was available before randomization. PDC was calculated for 250 participants.
Proportion of Days Covered (PDC), obtained from collection of electronic prescription and pharmacy fill data, and defined as the proportion of availability of medication for the period of interest. PDC range is 0 to 1.00 with higher values indicating greater proportion of days with medication as indicated by pharmacy records.
Outcome measures
| Measure |
Intervention
n=124 Participants
Participants received the relational agent and the AliveCor Kardia to use for 120 days.
Participants were directed to use the relational agent and AliveCor Kardia daily.
|
Usual Care
n=126 Participants
Participants received a brochure on atrial fibrillation that is published by the American Heart Association and a smartphone with the WebMD application.
Participants were directed to use the WebMD application as often as they would like.
|
|---|---|---|
|
Proportion of Days Covered
|
.97 Proportion of days covered
Interval 0.89 to 1.0
|
0.97 Proportion of days covered
Interval 0.92 to 1.0
|
PRIMARY outcome
Timeframe: 4, 8, and 12 monthsPopulation: Intervention 4-month: n=117 (11 withdrawals \[w/d\], 1 death; 4 discontinued \[d/c\] oral anticoagulation \[OAC\]; 2 missed visit) 8-month: n=114 (total 12 w/d, 4 deaths; 3 d/c OAC; 2 missed visit) 12-month: n=114 (total 12 w/d, 4 deaths, 5 d/c OAC) Control 4-month: n=121 (8 w/d, 4 deaths; 1 d/c OAC; 1 missed visit) 8-month: n=118 (total 8 w/d, 6 deaths; 3 d/c OAC) 12-month: n=115 (total 8 w/d, 6 deaths; 4 d/c OAC; 2 missed visit)
Self-reported adherence to oral anticoagulation. 3-item instrument with range 1-5 such that lower scores indicate more frequent medication adherence. Here the score is dichotomized by classifying participants reporting 1 for all three items as adherent and those that reported ≥ 2 on any item as non-adherent.
Outcome measures
| Measure |
Intervention
n=135 Participants
Participants received the relational agent and the AliveCor Kardia to use for 120 days.
Participants were directed to use the relational agent and AliveCor Kardia daily.
|
Usual Care
n=135 Participants
Participants received a brochure on atrial fibrillation that is published by the American Heart Association and a smartphone with the WebMD application.
Participants were directed to use the WebMD application as often as they would like.
|
|---|---|---|
|
Self-reported Adherence
Adherence-4 Months · Adherent
|
112 Participants
|
107 Participants
|
|
Self-reported Adherence
Adherence-4 Months · Non-adherent
|
5 Participants
|
14 Participants
|
|
Self-reported Adherence
Adherence-8 Months · Adherent
|
106 Participants
|
93 Participants
|
|
Self-reported Adherence
Adherence-8 Months · Non-adherent
|
8 Participants
|
25 Participants
|
|
Self-reported Adherence
Adherence-12 Months · Adherent
|
104 Participants
|
98 Participants
|
|
Self-reported Adherence
Adherence-12 Months · Non-adherent
|
10 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: 4, 8, and 12 monthsPopulation: Intervention arm: 4-month visit, n=121 (11 withdrawals, 1 death; 2 missed this visit) 8-month visit, n=117 (total 12 withdrawals, 4 deaths; 2 missed this visit) 12-month visit, n=119 (no additional withdrawals, no additional deaths, no missed visit) Control arm: 4-month visit, n=122 (8 withdrawals, 4 deaths; 1 missed this visit) 8-month visit, n=121 (total 6 deaths; no missed this visit) 12-month visit, n=119 (no additional withdrawals, no additional deaths; 2 missed this visit)
The AFEQT is a widely used measure of atrial fibrillation-specific health-related quality of life which consists of a global score and 4 domains (symptoms, daily activities, treatment concerns, and treatment satisfaction). Overall or subscale scores range from 0-100 with higher scores indicating superior health-related quality of life in AF. A score of 0 corresponds to complete disability (or responding "extremely" limited, difficult or bothersome to all questions answered), while a score of 100 corresponds to no disability (or responding "not at all" limited, difficult or bothersome to all questions answered).
Outcome measures
| Measure |
Intervention
n=135 Participants
Participants received the relational agent and the AliveCor Kardia to use for 120 days.
Participants were directed to use the relational agent and AliveCor Kardia daily.
|
Usual Care
n=135 Participants
Participants received a brochure on atrial fibrillation that is published by the American Heart Association and a smartphone with the WebMD application.
Participants were directed to use the WebMD application as often as they would like.
|
|---|---|---|
|
Atrial Fibrillation Effect on Quality of Life (AFEQT)
Symptoms : 4-month
|
87.5 score on a scale
Interval 70.8 to 95.8
|
91.7 score on a scale
Interval 75.0 to 100.0
|
|
Atrial Fibrillation Effect on Quality of Life (AFEQT)
Satisfaction: Control of Symptoms: 4-month
|
83.3 score on a scale
Interval 66.7 to 100.0
|
83.3 score on a scale
Interval 66.7 to 100.0
|
|
Atrial Fibrillation Effect on Quality of Life (AFEQT)
Satisfaction: Relief of Symptoms: 8-month
|
83.3 score on a scale
Interval 66.7 to 100.0
|
83.3 score on a scale
Interval 66.7 to 100.0
|
|
Atrial Fibrillation Effect on Quality of Life (AFEQT)
Satisfaction: Relief of Symptoms: 12-month
|
83.3 score on a scale
Interval 66.7 to 100.0
|
83.3 score on a scale
Interval 66.7 to 100.0
|
|
Atrial Fibrillation Effect on Quality of Life (AFEQT)
Satisfaction: Control of Symptoms: 8-month
|
83.3 score on a scale
Interval 66.7 to 100.0
|
83.3 score on a scale
Interval 66.7 to 100.0
|
|
Atrial Fibrillation Effect on Quality of Life (AFEQT)
Satisfaction: Control of Symptoms: 12-month
|
83.3 score on a scale
Interval 66.7 to 100.0
|
83.3 score on a scale
Interval 66.7 to 100.0
|
|
Atrial Fibrillation Effect on Quality of Life (AFEQT)
Overall Score : 4-month
|
77.8 score on a scale
Interval 60.2 to 88.0
|
75.9 score on a scale
Interval 63.0 to 90.7
|
|
Atrial Fibrillation Effect on Quality of Life (AFEQT)
Overall Score : 8-month
|
81.5 score on a scale
Interval 63.9 to 92.6
|
79.6 score on a scale
Interval 66.7 to 93.5
|
|
Atrial Fibrillation Effect on Quality of Life (AFEQT)
Overall Score: 12-month
|
80.6 score on a scale
Interval 63.9 to 88.9
|
77.8 score on a scale
Interval 62.0 to 90.7
|
|
Atrial Fibrillation Effect on Quality of Life (AFEQT)
Symptoms : 8-month
|
91.7 score on a scale
Interval 75.0 to 100.0
|
91.7 score on a scale
Interval 79.2 to 100.0
|
|
Atrial Fibrillation Effect on Quality of Life (AFEQT)
Symptoms : 12-month
|
91.7 score on a scale
Interval 70.8 to 100.0
|
91.7 score on a scale
Interval 75.0 to 100.0
|
|
Atrial Fibrillation Effect on Quality of Life (AFEQT)
Daily Activities : 4-month
|
70.8 score on a scale
Interval 41.7 to 85.4
|
68.8 score on a scale
Interval 50.0 to 89.6
|
|
Atrial Fibrillation Effect on Quality of Life (AFEQT)
Daily Activities : 8-month
|
75.0 score on a scale
Interval 54.2 to 91.7
|
75.00 score on a scale
Interval 54.2 to 93.8
|
|
Atrial Fibrillation Effect on Quality of Life (AFEQT)
Daily Activities : 12-month
|
70.8 score on a scale
Interval 47.9 to 87.5
|
72.9 score on a scale
Interval 45.8 to 89.6
|
|
Atrial Fibrillation Effect on Quality of Life (AFEQT)
Treatment Concern : 4-month
|
83.3 score on a scale
Interval 69.4 to 97.2
|
83.3 score on a scale
Interval 66.7 to 97.2
|
|
Atrial Fibrillation Effect on Quality of Life (AFEQT)
Treatment Concern : 8-month
|
88.9 score on a scale
Interval 72.2 to 97.2
|
86.1 score on a scale
Interval 69.4 to 94.2
|
|
Atrial Fibrillation Effect on Quality of Life (AFEQT)
Treatment Concern : 12-month
|
88.9 score on a scale
Interval 69.4 to 97.2
|
86.1 score on a scale
Interval 69.4 to 94.4
|
|
Atrial Fibrillation Effect on Quality of Life (AFEQT)
Satisfaction: Relief of Symptoms: 4-month
|
83.0 score on a scale
Interval 66.7 to 100.0
|
83.0 score on a scale
Interval 66.7 to 100.0
|
SECONDARY outcome
Timeframe: 4, 8, and 12 monthsPopulation: Intervention arm: 4-month visit, n=121 (11 withdrawals, 1 death; 2 missed this visit) 8-month visit, n=117 (total 12 withdrawals, 4 deaths; 2 missed this visit) 12-month visit, n=119 (no additional withdrawals, no additional deaths, no missed visit) Control arm: 4-month visit, n=122 (8 withdrawals, 4 deaths; 1 missed this visit) 8-month visit, n=121 (total 6 deaths; no missed this visit) 12-month visit, n=119 (no additional withdrawals, no additional deaths; 2 missed this visit)
Patient-Reported Outcomes Measurement Information System (PROMIS)-29 assesses 7 domains (physical function; depression and sadness; pain interference; satisfaction with participation in social roles and activities; fatigue; anxiety and fear; sleep disturbance), 4 questions each, and Pain Intensity with a single item. The 7 domain scores are transformed using a T-score with a mean of 50, standard deviation of 10, in a referent population. Higher scores indicate worse health for the depression, pain, fatigue, anxiety/sleep domains, while higher scores indicate better health for the physical function and satisfaction domains. The single Pain Intensity item is scored 0 (No pain) to 10 (Worst imaginable pain) in the past 7 days. Further details on PROMIS scoring are available at https://www.healthmeasures.net/images/PROMIS/manuals/PROMIS\_Adult\_Profile\_Scoring\_Manual.pdf.
Outcome measures
| Measure |
Intervention
n=135 Participants
Participants received the relational agent and the AliveCor Kardia to use for 120 days.
Participants were directed to use the relational agent and AliveCor Kardia daily.
|
Usual Care
n=135 Participants
Participants received a brochure on atrial fibrillation that is published by the American Heart Association and a smartphone with the WebMD application.
Participants were directed to use the WebMD application as often as they would like.
|
|---|---|---|
|
Patient-Reported Outcomes Measurement Information System (PROMIS)-29
Pain Intensity: 4 month
|
3 score on a scale
Interval 1.0 to 5.0
|
2 score on a scale
Interval 1.0 to 5.0
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS)-29
Physical Function: 4 month
|
41.4 score on a scale
Interval 35.8 to 47.6
|
41.8 score on a scale
Interval 36.9 to 56.9
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS)-29
Physical Function: 8 month
|
41.9 score on a scale
Interval 37.6 to 56.9
|
42.1 score on a scale
Interval 37.6 to 48.1
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS)-29
Physical Function: 12 month
|
41.4 score on a scale
Interval 36.4 to 48.2
|
41.7 score on a scale
Interval 36.4 to 56.9
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS)-29
Depression and Sadness: 4 month
|
48.9 score on a scale
Interval 41.0 to 55.5
|
41.0 score on a scale
Interval 41.0 to 54.3
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS)-29
Depression and Sadness: 8 month
|
41.0 score on a scale
Interval 41.0 to 53.0
|
41.0 score on a scale
Interval 41.0 to 53.0
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS)-29
Depression and Sadness: 12 month
|
41.0 score on a scale
Interval 41.0 to 55.5
|
41.0 score on a scale
Interval 41.0 to 55.5
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS)-29
Pain Interference: 4 month
|
55.7 score on a scale
Interval 41.6 to 61.3
|
54.85 score on a scale
Interval 41.6 to 61.3
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS)-29
Pain Interference: 8 month
|
54.5 score on a scale
Interval 41.6 to 60.0
|
54.4 score on a scale
Interval 41.6 to 59.9
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS)-29
Pain Interference: 12 month
|
53.9 score on a scale
Interval 41.6 to 61.3
|
53.9 score on a scale
Interval 41.6 to 59.7
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS)-29
Ability to Participate: 4 month
|
51.8 score on a scale
Interval 45.0 to 58.3
|
48.3 score on a scale
Interval 44.2 to 58.5
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS)-29
Ability to Participate: 8 month
|
51.8 score on a scale
Interval 44.2 to 58.1
|
51.8 score on a scale
Interval 46.0 to 64.2
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS)-29
Ability to Participate: 12 month
|
51.8 score on a scale
Interval 44.6 to 58.3
|
51.7 score on a scale
Interval 44.2 to 57.6
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS)-29
Fatigue: 4 month
|
51.0 score on a scale
Interval 46.4 to 59.3
|
53.1 score on a scale
Interval 46.1 to 58.9
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS)-29
Fatigue: 8 month
|
51.0 score on a scale
Interval 46.4 to 57.1
|
51.0 score on a scale
Interval 46.0 to 57.2
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS)-29
Fatigue: 12 month
|
51.0 score on a scale
Interval 46.0 to 57.1
|
51.3 score on a scale
Interval 48.6 to 60.7
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS)-29
Anxiety and Fear: 4 month
|
48.1 score on a scale
Interval 40.3 to 57.5
|
48.8 score on a scale
Interval 40.3 to 56.0
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS)-29
Anxiety and Fear: 8 month
|
48.1 score on a scale
Interval 40.3 to 55.6
|
47.9 score on a scale
Interval 40.3 to 56.0
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS)-29
Anxiety and Fear: 12 month
|
48.1 score on a scale
Interval 40.3 to 56.0
|
47.9 score on a scale
Interval 40.3 to 56.0
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS)-29
Sleep Disturbance: 4 month
|
51.4 score on a scale
Interval 43.8 to 55.8
|
51.1 score on a scale
Interval 44.2 to 54.5
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS)-29
Sleep Disturbance: 8 month
|
51.1 score on a scale
Interval 45.3 to 54.7
|
51.0 score on a scale
Interval 43.5 to 55.3
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS)-29
Sleep Disturbance: 12 month
|
51.1 score on a scale
Interval 44.6 to 55.5
|
51.7 score on a scale
Interval 45.1 to 55.5
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS)-29
Pain Intensity: 8 month
|
2 score on a scale
Interval 1.0 to 4.0
|
2 score on a scale
Interval 0.0 to 5.0
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS)-29
Pain Intensity: 12 month
|
3 score on a scale
Interval 0.0 to 5.0
|
3 score on a scale
Interval 0.0 to 5.0
|
SECONDARY outcome
Timeframe: 12 monthsThe number of participants with 1 or more emergency room visits will be quantified at 12 months. Data will be used to compare health care utilization between the two study arms.
Outcome measures
| Measure |
Intervention
n=135 Participants
Participants received the relational agent and the AliveCor Kardia to use for 120 days.
Participants were directed to use the relational agent and AliveCor Kardia daily.
|
Usual Care
n=135 Participants
Participants received a brochure on atrial fibrillation that is published by the American Heart Association and a smartphone with the WebMD application.
Participants were directed to use the WebMD application as often as they would like.
|
|---|---|---|
|
Emergency Room Visits
Participants with no ER visits
|
92 Participants
|
92 Participants
|
|
Emergency Room Visits
Participants with 1 or more ER visits
|
43 Participants
|
43 Participants
|
SECONDARY outcome
Timeframe: 12 monthsThe number of participants with one or more hospitalization will be quantified at 12 months. Data will be used to compare health care utilization between the two study arms.
Outcome measures
| Measure |
Intervention
n=135 Participants
Participants received the relational agent and the AliveCor Kardia to use for 120 days.
Participants were directed to use the relational agent and AliveCor Kardia daily.
|
Usual Care
n=135 Participants
Participants received a brochure on atrial fibrillation that is published by the American Heart Association and a smartphone with the WebMD application.
Participants were directed to use the WebMD application as often as they would like.
|
|---|---|---|
|
Hospital Admissions
Participants with no hospital admission
|
99 Participants
|
103 Participants
|
|
Hospital Admissions
Participants with 1 or more hospital admissions
|
36 Participants
|
32 Participants
|
Adverse Events
Intervention
Serious events: 35 serious events
Other events: 32 other events
Deaths: 4 deaths
Usual Care
Serious events: 31 serious events
Other events: 40 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Intervention
n=135 participants at risk
Receive the relational agent and the AliveCor Kardia for use for 120 days. Participants are directed to use these interventions daily.
Relational agent/AliveCor Kardia - Intervention: Use of the relational agent and Kardia daily for 120 days.
|
Usual Care
n=135 participants at risk
Receive a brochure on atrial fibrillation that is published by the American Heart Association and a smartphone with the WebMD application.
Participants are directed to use the WebMD application as often as they would like.
Usual Care: Use of the WebMD app daily for 120 days.
|
|---|---|---|
|
Blood and lymphatic system disorders
Other
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.00%
0/135 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Cardiac disorders
Atrial fibrillation
|
8.9%
12/135 • Number of events 12 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.00%
0/135 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Cardiac disorders
Chest pain
|
1.5%
2/135 • Number of events 2 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.00%
0/135 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Cardiac disorders
Heart failure
|
1.5%
2/135 • Number of events 2 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Cardiac disorders
Myocardial infarction
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Cardiac disorders
Palpitations
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.00%
0/135 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Cardiac disorders
Sinus bradycardia
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.00%
0/135 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Cardiac disorders
Other
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.00%
0/135 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/135 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
1.5%
2/135 • Number of events 2 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Gastrointestinal disorders
Colitis
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.00%
0/135 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
1.5%
2/135 • Number of events 2 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
1.5%
2/135 • Number of events 2 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Gastrointestinal disorders
Retroperitoneal hemorrhage
|
0.00%
0/135 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Gastrointestinal disorders
Salivary duct inflamation
|
0.00%
0/135 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Gastrointestinal disorders
Small intestine obstruction
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.00%
0/135 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Gastrointestinal disorders
Other
|
1.5%
2/135 • Number of events 2 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.00%
0/135 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
General disorders
Death NOS
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
General disorders
Fatigue
|
0.00%
0/135 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
General disorders
Fever
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.00%
0/135 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
General disorders
Pain
|
0.00%
0/135 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
1.5%
2/135 • Number of events 2 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
General disorders
COVID-19
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.00%
0/135 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
General disorders
Other
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.00%
0/135 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
General disorders
Cholecystitis
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Infections and infestations
Appendicitis
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.00%
0/135 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Infections and infestations
Endocarditis infective
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.00%
0/135 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Infections and infestations
Gallbladder infection
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.00%
0/135 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Infections and infestations
Joint infection
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.00%
0/135 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Infections and infestations
Sepsis
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
2.2%
3/135 • Number of events 3 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Infections and infestations
Skin infection
|
0.00%
0/135 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
1.5%
2/135 • Number of events 2 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Infections and infestations
Wound infection
|
0.00%
0/135 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.74%
1/135 • Number of events 2 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Injury, poisoning and procedural complications
Arterial injury
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.00%
0/135 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/135 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Injury, poisoning and procedural complications
Fall
|
2.2%
3/135 • Number of events 3 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
3.7%
5/135 • Number of events 7 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.00%
0/135 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.00%
0/135 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Injury, poisoning and procedural complications
Other
|
0.00%
0/135 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/135 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/135 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Nervous system disorders
Stroke
|
0.74%
1/135 • Number of events 2 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
2.2%
3/135 • Number of events 4 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Nervous system disorders
Syncope
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Nervous system disorders
Transient ischemic attacks
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.00%
0/135 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
Other adverse events
| Measure |
Intervention
n=135 participants at risk
Receive the relational agent and the AliveCor Kardia for use for 120 days. Participants are directed to use these interventions daily.
Relational agent/AliveCor Kardia - Intervention: Use of the relational agent and Kardia daily for 120 days.
|
Usual Care
n=135 participants at risk
Receive a brochure on atrial fibrillation that is published by the American Heart Association and a smartphone with the WebMD application.
Participants are directed to use the WebMD application as often as they would like.
Usual Care: Use of the WebMD app daily for 120 days.
|
|---|---|---|
|
Immune system disorders
Allergic reaction
|
0.00%
0/135 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Blood and lymphatic system disorders
Anemia
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.00%
0/135 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Cardiac disorders
Atrial fibrillation
|
2.2%
3/135 • Number of events 6 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
3.0%
4/135 • Number of events 4 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Cardiac disorders
Chest pain-cardiac
|
1.5%
2/135 • Number of events 3 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
2.2%
3/135 • Number of events 4 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Cardiac disorders
Heart Failure
|
1.5%
2/135 • Number of events 2 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Cardiac disorders
Myocardial infarction
|
1.5%
2/135 • Number of events 2 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.00%
0/135 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Cardiac disorders
Palpitations
|
1.5%
2/135 • Number of events 2 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Ear and labyrinth disorders
Vertigo
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Eye disorders
Blurred vision
|
0.00%
0/135 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/135 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
1.5%
2/135 • Number of events 2 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Gastrointestinal disorders
Nausea
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.00%
0/135 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Gastrointestinal disorders
Toothache
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.00%
0/135 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Gastrointestinal disorders
Other
|
1.5%
2/135 • Number of events 2 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.00%
0/135 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
General disorders
Edema limbs
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.00%
0/135 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
General disorders
Fatigue
|
0.00%
0/135 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
General disorders
Fever
|
0.00%
0/135 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/135 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
General disorders
Pain
|
0.00%
0/135 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.74%
1/135 • Number of events 2 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
General disorders
COVID-19
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
1.5%
2/135 • Number of events 2 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
General disorders
Other
|
0.00%
0/135 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Infections and infestations
Bronchial infection
|
0.00%
0/135 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Infections and infestations
Urinary tract infection
|
1.5%
2/135 • Number of events 2 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.00%
0/135 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Injury, poisoning and procedural complications
Fall
|
4.4%
6/135 • Number of events 7 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
2.2%
3/135 • Number of events 3 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/135 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Injury, poisoning and procedural complications
Postoperative hemorrhage
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.00%
0/135 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/135 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Injury, poisoning and procedural complications
Other
|
1.5%
2/135 • Number of events 2 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
4.4%
6/135 • Number of events 7 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Investigations
INR increased
|
0.00%
0/135 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/135 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/135 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
1.5%
2/135 • Number of events 2 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.5%
2/135 • Number of events 2 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
1.5%
2/135 • Number of events 2 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff injury
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Musculoskeletal and connective tissue disorders
Other
|
0.00%
0/135 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
1.5%
2/135 • Number of events 2 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Other
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.00%
0/135 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/135 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Nervous system disorders
Facial muscle weakness
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.00%
0/135 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Nervous system disorders
Headache
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/135 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/135 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Renal and urinary disorders
Renal calculi
|
0.00%
0/135 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/135 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
1.5%
2/135 • Number of events 2 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.74%
1/135 • Number of events 2 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.5%
2/135 • Number of events 2 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
1.5%
2/135 • Number of events 2 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Respiratory, thoracic and mediastinal disorders
Other
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.00%
0/135 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/135 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Skin and subcutaneous tissue disorders
Other
|
0.00%
0/135 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Vascular disorders
Hematoma
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.00%
0/135 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/135 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/135 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/135 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
1.5%
2/135 • Number of events 2 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
2.2%
3/135 • Number of events 3 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Surgical and medical procedures
Other
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Vascular disorders
Hypotension
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.00%
0/135 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
Vascular disorders
Peripheral ischemia
|
0.00%
0/135 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
|
General disorders
Unknown classification
|
0.00%
0/135 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
0.74%
1/135 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit.
The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place