Trial Outcomes & Findings for Improving Self-care of Heart Failure Caregivers (NCT NCT03988621)
NCT ID: NCT03988621
Last Updated: 2025-02-20
Results Overview
The Health Self-Care Neglect (HSCN) scale measures an individual's neglect of self-care behaviors. It consists of 9 yes or no questions. Scores range from 0-9. Higher scores indicating more self-care neglect.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
343 participants
Primary outcome timeframe
The primary outcome was analyzed at 6 months (baseline compared to 6 months) but data were collected at 9- and 12-months to assess sustainability.
Results posted on
2025-02-20
Participant Flow
677 caregivers were screened for eligibility from a regional HF referral center in the US from August 2019- November 2022. 502 were eligible, 50% of those declined participation and 26% did not meet inclusion criteria. 250 caregivers were enrolled and consented for participation. 93 patients associated with the enrolled caregivers were consented to participate. Patient enrollment exceeded the targeted goal of 40.
Enrolled caregivers were stratified by race, relationship to caregiver, and sex prior to assignment of intervention arm.
Participant milestones
| Measure |
Intervention
Caregivers randomized to the intervention (Virtual Caregiver Coach for You \[ViCCY\]) received 10 sessions of virtual health coaching by health coaches over 6 months. Intervention content was based on the theoretical framework (Transactional Model of Stress and Coping) and prior research. Sessions were individual and virtual (provided using tablets). The health coaches helped caregivers gain the knowledge and skills needed to achieve their self-identified health goals through self-care. We focused on identifying personal values, solving problems, and transforming goals into action. ViCCY is standardized in a treatment manual. Because stress does not affect all people equally, the intervention was tailored to individual appraisals and the factors most likely to influence demand and perceived burden.
ViCCY: Virtual Caregiver Coach for You
|
Control
Caregivers in the control group received Health Information delivered through a Samsung tablet programmed with health information websites. They were asked to spend at least 30 minutes weekly using the computer tablet provided to them by the study team to access the recommended websites
|
|---|---|---|
|
Overall Study
STARTED
|
167
|
176
|
|
Overall Study
Started (Caregivers)
|
125
|
125
|
|
Overall Study
3-Month Survey(Caregivers)
|
93
|
103
|
|
Overall Study
6-Month Survey(Caregivers)
|
93
|
101
|
|
Overall Study
9-Month Survey(Caregivers)
|
103
|
104
|
|
Overall Study
12-Month Survey(Caregivers)
|
95
|
101
|
|
Overall Study
Started (Patients)
|
42
|
51
|
|
Overall Study
12 Month Survey/Completed(Patients)
|
26
|
31
|
|
Overall Study
COMPLETED
|
121
|
132
|
|
Overall Study
NOT COMPLETED
|
46
|
44
|
Reasons for withdrawal
| Measure |
Intervention
Caregivers randomized to the intervention (Virtual Caregiver Coach for You \[ViCCY\]) received 10 sessions of virtual health coaching by health coaches over 6 months. Intervention content was based on the theoretical framework (Transactional Model of Stress and Coping) and prior research. Sessions were individual and virtual (provided using tablets). The health coaches helped caregivers gain the knowledge and skills needed to achieve their self-identified health goals through self-care. We focused on identifying personal values, solving problems, and transforming goals into action. ViCCY is standardized in a treatment manual. Because stress does not affect all people equally, the intervention was tailored to individual appraisals and the factors most likely to influence demand and perceived burden.
ViCCY: Virtual Caregiver Coach for You
|
Control
Caregivers in the control group received Health Information delivered through a Samsung tablet programmed with health information websites. They were asked to spend at least 30 minutes weekly using the computer tablet provided to them by the study team to access the recommended websites
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
16
|
17
|
|
Overall Study
Withdrawal by Subject
|
14
|
7
|
|
Overall Study
Patient Lost to Follow Up
|
15
|
15
|
|
Overall Study
Patient death
|
1
|
5
|
Baseline Characteristics
Analysis population consists of 250 caregivers and 93 patients.
Baseline characteristics by cohort
| Measure |
Intervention
n=167 Participants
Caregivers randomized to the intervention (Virtual Caregiver Coach for You \[ViCCY\]) received 10 sessions of virtual health coaching by health coaches over 6 months. Intervention content was based on the theoretical framework (Transactional Model of Stress and Coping) and prior research. Sessions were individual and virtual (provided using tablets). The health coaches helped caregivers gain the knowledge and skills needed to achieve their self-identified health goals through self-care. We focused on identifying personal values, solving problems, and transforming goals into action. ViCCY is standardized in a treatment manual. Because stress does not affect all people equally, the intervention was tailored to individual appraisals and the factors most likely to influence demand and perceived burden.
ViCCY: Virtual Health Coaching for You
|
Control
n=176 Participants
Caregivers randomized to the control group received Health Information on Samsung tablets. They were asked to spend at least 30 minutes weekly using the computer tablets to access recommended websites.
|
Total
n=343 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Caregiver Age
|
55.4 Years
STANDARD_DEVIATION 13.78 • n=125 Participants • Analysis population consists of 250 caregivers and 93 patients.
|
55.3 Years
STANDARD_DEVIATION 13.55 • n=125 Participants • Analysis population consists of 250 caregivers and 93 patients.
|
55.3 Years
STANDARD_DEVIATION 13.64 • n=250 Participants • Analysis population consists of 250 caregivers and 93 patients.
|
|
Age, Continuous
Patient Age
|
56.1 Years
STANDARD_DEVIATION 16.34 • n=42 Participants • Analysis population consists of 250 caregivers and 93 patients.
|
56.9 Years
STANDARD_DEVIATION 15.37 • n=51 Participants • Analysis population consists of 250 caregivers and 93 patients.
|
56.5 Years
STANDARD_DEVIATION 15.73 • n=93 Participants • Analysis population consists of 250 caregivers and 93 patients.
|
|
Sex: Female, Male
Caregiver Data · Female
|
106 Participants
n=125 Participants • Analysis population consists of 250 caregivers and 93 patients
|
107 Participants
n=125 Participants • Analysis population consists of 250 caregivers and 93 patients
|
213 Participants
n=250 Participants • Analysis population consists of 250 caregivers and 93 patients
|
|
Sex: Female, Male
Caregiver Data · Male
|
19 Participants
n=125 Participants • Analysis population consists of 250 caregivers and 93 patients
|
18 Participants
n=125 Participants • Analysis population consists of 250 caregivers and 93 patients
|
37 Participants
n=250 Participants • Analysis population consists of 250 caregivers and 93 patients
|
|
Sex: Female, Male
Patient Data · Female
|
10 Participants
n=42 Participants • Analysis population consists of 250 caregivers and 93 patients
|
10 Participants
n=51 Participants • Analysis population consists of 250 caregivers and 93 patients
|
20 Participants
n=93 Participants • Analysis population consists of 250 caregivers and 93 patients
|
|
Sex: Female, Male
Patient Data · Male
|
32 Participants
n=42 Participants • Analysis population consists of 250 caregivers and 93 patients
|
41 Participants
n=51 Participants • Analysis population consists of 250 caregivers and 93 patients
|
73 Participants
n=93 Participants • Analysis population consists of 250 caregivers and 93 patients
|
|
Ethnicity (NIH/OMB)
Caregiver Data · Hispanic or Latino
|
5 Participants
n=125 Participants • Analysis population consists of 250 caregivers and 93 patients
|
4 Participants
n=125 Participants • Analysis population consists of 250 caregivers and 93 patients
|
9 Participants
n=250 Participants • Analysis population consists of 250 caregivers and 93 patients
|
|
Ethnicity (NIH/OMB)
Caregiver Data · Not Hispanic or Latino
|
119 Participants
n=125 Participants • Analysis population consists of 250 caregivers and 93 patients
|
120 Participants
n=125 Participants • Analysis population consists of 250 caregivers and 93 patients
|
239 Participants
n=250 Participants • Analysis population consists of 250 caregivers and 93 patients
|
|
Ethnicity (NIH/OMB)
Caregiver Data · Unknown or Not Reported
|
1 Participants
n=125 Participants • Analysis population consists of 250 caregivers and 93 patients
|
1 Participants
n=125 Participants • Analysis population consists of 250 caregivers and 93 patients
|
2 Participants
n=250 Participants • Analysis population consists of 250 caregivers and 93 patients
|
|
Ethnicity (NIH/OMB)
Patient Data · Hispanic or Latino
|
1 Participants
n=42 Participants • Analysis population consists of 250 caregivers and 93 patients
|
0 Participants
n=51 Participants • Analysis population consists of 250 caregivers and 93 patients
|
1 Participants
n=93 Participants • Analysis population consists of 250 caregivers and 93 patients
|
|
Ethnicity (NIH/OMB)
Patient Data · Not Hispanic or Latino
|
41 Participants
n=42 Participants • Analysis population consists of 250 caregivers and 93 patients
|
50 Participants
n=51 Participants • Analysis population consists of 250 caregivers and 93 patients
|
91 Participants
n=93 Participants • Analysis population consists of 250 caregivers and 93 patients
|
|
Ethnicity (NIH/OMB)
Patient Data · Unknown or Not Reported
|
0 Participants
n=42 Participants • Analysis population consists of 250 caregivers and 93 patients
|
1 Participants
n=51 Participants • Analysis population consists of 250 caregivers and 93 patients
|
1 Participants
n=93 Participants • Analysis population consists of 250 caregivers and 93 patients
|
|
Race (NIH/OMB)
Caregiver Data · American Indian or Alaska Native
|
0 Participants
n=125 Participants • Analysis population consists of 250 caregivers and 93 patients
|
0 Participants
n=125 Participants • Analysis population consists of 250 caregivers and 93 patients
|
0 Participants
n=250 Participants • Analysis population consists of 250 caregivers and 93 patients
|
|
Race (NIH/OMB)
Caregiver Data · Asian
|
1 Participants
n=125 Participants • Analysis population consists of 250 caregivers and 93 patients
|
3 Participants
n=125 Participants • Analysis population consists of 250 caregivers and 93 patients
|
4 Participants
n=250 Participants • Analysis population consists of 250 caregivers and 93 patients
|
|
Race (NIH/OMB)
Caregiver Data · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=125 Participants • Analysis population consists of 250 caregivers and 93 patients
|
0 Participants
n=125 Participants • Analysis population consists of 250 caregivers and 93 patients
|
0 Participants
n=250 Participants • Analysis population consists of 250 caregivers and 93 patients
|
|
Race (NIH/OMB)
Caregiver Data · Black or African American
|
35 Participants
n=125 Participants • Analysis population consists of 250 caregivers and 93 patients
|
39 Participants
n=125 Participants • Analysis population consists of 250 caregivers and 93 patients
|
74 Participants
n=250 Participants • Analysis population consists of 250 caregivers and 93 patients
|
|
Race (NIH/OMB)
Caregiver Data · White
|
79 Participants
n=125 Participants • Analysis population consists of 250 caregivers and 93 patients
|
76 Participants
n=125 Participants • Analysis population consists of 250 caregivers and 93 patients
|
155 Participants
n=250 Participants • Analysis population consists of 250 caregivers and 93 patients
|
|
Race (NIH/OMB)
Caregiver Data · More than one race
|
6 Participants
n=125 Participants • Analysis population consists of 250 caregivers and 93 patients
|
5 Participants
n=125 Participants • Analysis population consists of 250 caregivers and 93 patients
|
11 Participants
n=250 Participants • Analysis population consists of 250 caregivers and 93 patients
|
|
Race (NIH/OMB)
Caregiver Data · Unknown or Not Reported
|
4 Participants
n=125 Participants • Analysis population consists of 250 caregivers and 93 patients
|
2 Participants
n=125 Participants • Analysis population consists of 250 caregivers and 93 patients
|
6 Participants
n=250 Participants • Analysis population consists of 250 caregivers and 93 patients
|
|
Race (NIH/OMB)
Patient Data · American Indian or Alaska Native
|
0 Participants
n=42 Participants • Analysis population consists of 250 caregivers and 93 patients
|
1 Participants
n=51 Participants • Analysis population consists of 250 caregivers and 93 patients
|
1 Participants
n=93 Participants • Analysis population consists of 250 caregivers and 93 patients
|
|
Race (NIH/OMB)
Patient Data · Asian
|
0 Participants
n=42 Participants • Analysis population consists of 250 caregivers and 93 patients
|
0 Participants
n=51 Participants • Analysis population consists of 250 caregivers and 93 patients
|
0 Participants
n=93 Participants • Analysis population consists of 250 caregivers and 93 patients
|
|
Race (NIH/OMB)
Patient Data · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=42 Participants • Analysis population consists of 250 caregivers and 93 patients
|
1 Participants
n=51 Participants • Analysis population consists of 250 caregivers and 93 patients
|
1 Participants
n=93 Participants • Analysis population consists of 250 caregivers and 93 patients
|
|
Race (NIH/OMB)
Patient Data · Black or African American
|
8 Participants
n=42 Participants • Analysis population consists of 250 caregivers and 93 patients
|
12 Participants
n=51 Participants • Analysis population consists of 250 caregivers and 93 patients
|
20 Participants
n=93 Participants • Analysis population consists of 250 caregivers and 93 patients
|
|
Race (NIH/OMB)
Patient Data · White
|
31 Participants
n=42 Participants • Analysis population consists of 250 caregivers and 93 patients
|
37 Participants
n=51 Participants • Analysis population consists of 250 caregivers and 93 patients
|
68 Participants
n=93 Participants • Analysis population consists of 250 caregivers and 93 patients
|
|
Race (NIH/OMB)
Patient Data · More than one race
|
2 Participants
n=42 Participants • Analysis population consists of 250 caregivers and 93 patients
|
0 Participants
n=51 Participants • Analysis population consists of 250 caregivers and 93 patients
|
2 Participants
n=93 Participants • Analysis population consists of 250 caregivers and 93 patients
|
|
Race (NIH/OMB)
Patient Data · Unknown or Not Reported
|
1 Participants
n=42 Participants • Analysis population consists of 250 caregivers and 93 patients
|
0 Participants
n=51 Participants • Analysis population consists of 250 caregivers and 93 patients
|
1 Participants
n=93 Participants • Analysis population consists of 250 caregivers and 93 patients
|
|
Self Care Maintenance
|
68.8 units on a scale
STANDARD_DEVIATION 16.1 • n=124 Participants • 250 caregivers analyzed. One caregiver did not provide sufficient data for the Self Care Inventory survey and thus has a missing value for the score.
|
68.2 units on a scale
STANDARD_DEVIATION 15.7 • n=125 Participants • 250 caregivers analyzed. One caregiver did not provide sufficient data for the Self Care Inventory survey and thus has a missing value for the score.
|
68.5 units on a scale
STANDARD_DEVIATION 15.9 • n=249 Participants • 250 caregivers analyzed. One caregiver did not provide sufficient data for the Self Care Inventory survey and thus has a missing value for the score.
|
|
Years as caregiver
|
3.75 years
n=124 Participants • 250 caregivers analyzed. One caregiver did not provide sufficient data for the Years Caregiving survey question and thus has a missing value for the score.
|
3.00 years
n=125 Participants • 250 caregivers analyzed. One caregiver did not provide sufficient data for the Years Caregiving survey question and thus has a missing value for the score.
|
3.25 years
n=249 Participants • 250 caregivers analyzed. One caregiver did not provide sufficient data for the Years Caregiving survey question and thus has a missing value for the score.
|
|
Hours caregiver per day
|
8.2 Hours
STANDARD_DEVIATION 7.5 • n=123 Participants • 250 caregivers analyzed. Three caregivers did not provide sufficient data for this measure at baseline.
|
7.9 Hours
STANDARD_DEVIATION 7.5 • n=124 Participants • 250 caregivers analyzed. Three caregivers did not provide sufficient data for this measure at baseline.
|
8.1 Hours
STANDARD_DEVIATION 7.5 • n=247 Participants • 250 caregivers analyzed. Three caregivers did not provide sufficient data for this measure at baseline.
|
|
Health Self-care Neglect (HSCN) scale
|
4.9 units on a scale
STANDARD_DEVIATION 2.1 • n=125 Participants • 250 Caregivers Analyzed
|
5.0 units on a scale
STANDARD_DEVIATION 2.1 • n=125 Participants • 250 Caregivers Analyzed
|
4.9 units on a scale
STANDARD_DEVIATION 2.1 • n=250 Participants • 250 Caregivers Analyzed
|
|
Perceived Stress Scale
|
25.9 units on a scale
STANDARD_DEVIATION 7.5 • n=123 Participants • 250 caregivers analyzed. Two caregivers did not provide sufficient data for this measure at baseline.
|
26.5 units on a scale
STANDARD_DEVIATION 7.7 • n=125 Participants • 250 caregivers analyzed. Two caregivers did not provide sufficient data for this measure at baseline.
|
26.2 units on a scale
STANDARD_DEVIATION 7.6 • n=248 Participants • 250 caregivers analyzed. Two caregivers did not provide sufficient data for this measure at baseline.
|
|
Active Coping Subscale
|
22.6 units on a scale
STANDARD_DEVIATION 9.1 • n=120 Participants • 250 caregivers analyzed. Six caregivers did not provide sufficient data for this measure at baseline.
|
22.9 units on a scale
STANDARD_DEVIATION 10.3 • n=124 Participants • 250 caregivers analyzed. Six caregivers did not provide sufficient data for this measure at baseline.
|
22.7 units on a scale
STANDARD_DEVIATION 9.7 • n=244 Participants • 250 caregivers analyzed. Six caregivers did not provide sufficient data for this measure at baseline.
|
|
Avoidance Coping Subscale
|
9.0 units on a scale
STANDARD_DEVIATION 5.9 • n=120 Participants • 250 caregivers analyzed. Five caregivers did not provide sufficient data for this measure at baseline.
|
10.7 units on a scale
STANDARD_DEVIATION 6.4 • n=125 Participants • 250 caregivers analyzed. Five caregivers did not provide sufficient data for this measure at baseline.
|
9.9 units on a scale
STANDARD_DEVIATION 6.2 • n=245 Participants • 250 caregivers analyzed. Five caregivers did not provide sufficient data for this measure at baseline.
|
|
Minimization Coping Subscale
|
11.8 units on a scale
STANDARD_DEVIATION 5.4 • n=119 Participants • 250 caregivers analyzed. Eight caregivers did not provide sufficient data for this measure at baseline.
|
12.9 units on a scale
STANDARD_DEVIATION 5.6 • n=123 Participants • 250 caregivers analyzed. Eight caregivers did not provide sufficient data for this measure at baseline.
|
12.3 units on a scale
STANDARD_DEVIATION 5.5 • n=242 Participants • 250 caregivers analyzed. Eight caregivers did not provide sufficient data for this measure at baseline.
|
|
Short Form (SF)-36 Physical Health Status
|
48.0 units on a scale
STANDARD_DEVIATION 10.1 • n=120 Participants • 250 caregivers analyzed. Seven caregivers did not provide sufficient data for this measure at baseline.
|
47.3 units on a scale
STANDARD_DEVIATION 9.6 • n=123 Participants • 250 caregivers analyzed. Seven caregivers did not provide sufficient data for this measure at baseline.
|
47.6 units on a scale
STANDARD_DEVIATION 9.8 • n=243 Participants • 250 caregivers analyzed. Seven caregivers did not provide sufficient data for this measure at baseline.
|
|
Short Form (SF)-36- Mental Health Status
|
43.2 units on a scale
STANDARD_DEVIATION 12.3 • n=120 Participants • 250 caregivers analyzed. Seven caregivers did not provide sufficient data for this measure at baseline.
|
41.1 units on a scale
STANDARD_DEVIATION 12.2 • n=123 Participants • 250 caregivers analyzed. Seven caregivers did not provide sufficient data for this measure at baseline.
|
42.1 units on a scale
STANDARD_DEVIATION 12.3 • n=243 Participants • 250 caregivers analyzed. Seven caregivers did not provide sufficient data for this measure at baseline.
|
PRIMARY outcome
Timeframe: The primary outcome was analyzed at 6 months (baseline compared to 6 months) but data were collected at 9- and 12-months to assess sustainability.Population: Number of participants analyzed differs across timepoints due to participant attrition, missing data due to nonresponse, and/or missed study timepoints.
The Health Self-Care Neglect (HSCN) scale measures an individual's neglect of self-care behaviors. It consists of 9 yes or no questions. Scores range from 0-9. Higher scores indicating more self-care neglect.
Outcome measures
| Measure |
Intervention
n=125 Participants
Caregivers randomized to the intervention received 10 sessions of virtual health coaching by trained health coaches over 6 months. Content of the sessions was guided by the Transactional Model of Stress and Coping and prior research. Sessions were provided virtually using tablets. We called the intervention ViCCY (virtual caregiver coach for you) and sought to help caregivers gain the knowledge and skills needed to achieve their health goals through self-care. We focus on identifying personal values, solving problems, and transforming goals into action. ViCCY is standardized in a treatment manual. Because stress does not affect all people equally, the intervention is tailored to individual appraisals and the factors most likely to influence demand and perceived burden.
ViCCY: Virtual Health Coaching for You
|
Control
n=125 Participants
The control group received only Health Information (HI) delivered through the internet.
|
|---|---|---|
|
Change in the Health Self-Care Neglect (HSCN) Scale
HSCN 6 Month Score
|
2.67 score on a scale
Standard Deviation 2.09
|
3.49 score on a scale
Standard Deviation 2.16
|
|
Change in the Health Self-Care Neglect (HSCN) Scale
HSCN Baseline Score
|
4.89 score on a scale
Standard Deviation 2.07
|
4.97 score on a scale
Standard Deviation 2.12
|
|
Change in the Health Self-Care Neglect (HSCN) Scale
HSCN 3 Month Score
|
3.09 score on a scale
Standard Deviation 2.07
|
3.50 score on a scale
Standard Deviation 2.17
|
|
Change in the Health Self-Care Neglect (HSCN) Scale
HSCN 9 Month Score
|
2.34 score on a scale
Standard Deviation 1.99
|
3.02 score on a scale
Standard Deviation 2.24
|
|
Change in the Health Self-Care Neglect (HSCN) Scale
HSCN 12 Month Score
|
2.57 score on a scale
Standard Deviation 2.10
|
3.09 score on a scale
Standard Deviation 2.17
|
PRIMARY outcome
Timeframe: The primary outcome was analyzed at 6 months (baseline compared to 6 months) but data were collected at 9- and 12-months to assess sustainability.Population: Number of participants analyzed differs across timepoints due to participant attrition, missing data due to nonresponse, and/or missed study timepoints.
The Self-Care Inventory is a 20 item inventory with 3 embedded scales (self-care maintenance, monitoring, and management). The outcome used in this study was the 8-item Self-Care Maintenance Scale. Responses are added and standardized to range from 0-100. A higher score indicates better self-care.
Outcome measures
| Measure |
Intervention
n=125 Participants
Caregivers randomized to the intervention received 10 sessions of virtual health coaching by trained health coaches over 6 months. Content of the sessions was guided by the Transactional Model of Stress and Coping and prior research. Sessions were provided virtually using tablets. We called the intervention ViCCY (virtual caregiver coach for you) and sought to help caregivers gain the knowledge and skills needed to achieve their health goals through self-care. We focus on identifying personal values, solving problems, and transforming goals into action. ViCCY is standardized in a treatment manual. Because stress does not affect all people equally, the intervention is tailored to individual appraisals and the factors most likely to influence demand and perceived burden.
ViCCY: Virtual Health Coaching for You
|
Control
n=125 Participants
The control group received only Health Information (HI) delivered through the internet.
|
|---|---|---|
|
Change in the Self-Care Inventory, Maintenance Scale
Self Care Maintenance, Baseline Score
|
68.83 score on a scale
Standard Deviation 16.09
|
68.15 score on a scale
Standard Deviation 15.73
|
|
Change in the Self-Care Inventory, Maintenance Scale
Self Care Maintenance, 6 Month Score
|
79.86 score on a scale
Standard Deviation 12.29
|
72.85 score on a scale
Standard Deviation 12.35
|
|
Change in the Self-Care Inventory, Maintenance Scale
Self Care Maintenance, 12 Month Score
|
76.62 score on a scale
Standard Deviation 13.26
|
74.58 score on a scale
Standard Deviation 14.61
|
SECONDARY outcome
Timeframe: Main analysis was Baseline to 6 months. Data will be analyzed at 12 months to determine sustainability of intervention effect.Population: Number of participants analyzed differs across timepoints due to participant attrition, missing data due to nonresponse, and/or missed study timepoints.
The Perceived Stress Scale (PSS), a 14-item instrument that provides a global rating of an individual's belief in the severity and frequency of stressful experiences during the last month. The Perceived Stress Scale includes 14 items designed to assess symptoms of stress and global measures of the degree of stress experienced in the past month. Each item is scored from 0 (never) to 4 (very often), with total sum scores ranging from 0 to 56; higher scores indicate higher perceived stress. In prior test, Cronbach's alpha of the scale ranged from 0.84 to 0.86, and was 0.91 for older African American and European American females.
Outcome measures
| Measure |
Intervention
n=125 Participants
Caregivers randomized to the intervention received 10 sessions of virtual health coaching by trained health coaches over 6 months. Content of the sessions was guided by the Transactional Model of Stress and Coping and prior research. Sessions were provided virtually using tablets. We called the intervention ViCCY (virtual caregiver coach for you) and sought to help caregivers gain the knowledge and skills needed to achieve their health goals through self-care. We focus on identifying personal values, solving problems, and transforming goals into action. ViCCY is standardized in a treatment manual. Because stress does not affect all people equally, the intervention is tailored to individual appraisals and the factors most likely to influence demand and perceived burden.
ViCCY: Virtual Health Coaching for You
|
Control
n=125 Participants
The control group received only Health Information (HI) delivered through the internet.
|
|---|---|---|
|
Change in the Perceived Stress Scale (PSS)
PSS Baseline Score
|
25.91 Score on a scale
Standard Deviation 7.48
|
26.49 Score on a scale
Standard Deviation 7.73
|
|
Change in the Perceived Stress Scale (PSS)
PSS 6 Month Score
|
19.73 Score on a scale
Standard Deviation 6.97
|
25.20 Score on a scale
Standard Deviation 8.71
|
|
Change in the Perceived Stress Scale (PSS)
PSS 12 Month Score
|
20.76 Score on a scale
Standard Deviation 8.39
|
24.00 Score on a scale
Standard Deviation 9.02
|
SECONDARY outcome
Timeframe: The primary analysis was at 6 months (baseline compared to 6 months) but data were collected at 9- and 12-months to assess sustainability.Population: Number of participants analyzed differs across timepoints due to participant attrition, missing data due to nonresponse, and/or missed study timepoints.
We used a 30-item modification of the original 42-item questionnaire developed by Lazarus in 1985. We measured these coping styles: active, avoidance, and minimization. The instrument uses a 4-point Likert-scale response format (0 = not used to 3 = used a great deal). Scores range from 0-45, 0-30, and 0-30 for the active, avoidance and minimization subscales, respectively. Higher scores indicate greater use of particular coping styles.
Outcome measures
| Measure |
Intervention
n=125 Participants
Caregivers randomized to the intervention received 10 sessions of virtual health coaching by trained health coaches over 6 months. Content of the sessions was guided by the Transactional Model of Stress and Coping and prior research. Sessions were provided virtually using tablets. We called the intervention ViCCY (virtual caregiver coach for you) and sought to help caregivers gain the knowledge and skills needed to achieve their health goals through self-care. We focus on identifying personal values, solving problems, and transforming goals into action. ViCCY is standardized in a treatment manual. Because stress does not affect all people equally, the intervention is tailored to individual appraisals and the factors most likely to influence demand and perceived burden.
ViCCY: Virtual Health Coaching for You
|
Control
n=125 Participants
The control group received only Health Information (HI) delivered through the internet.
|
|---|---|---|
|
Change in the Ways of Coping Questionnaire
Minimize Coping 9 Month Score
|
11.95 Score on a scale
Standard Deviation 4.58
|
12.15 Score on a scale
Standard Deviation 4.73
|
|
Change in the Ways of Coping Questionnaire
Avoidance Coping Baseline Score
|
9.04 Score on a scale
Standard Deviation 5.86
|
10.72 Score on a scale
Standard Deviation 6.37
|
|
Change in the Ways of Coping Questionnaire
Avoidance Coping 3 Month Score
|
8.95 Score on a scale
Standard Deviation 5.72
|
9.01 Score on a scale
Standard Deviation 6.22
|
|
Change in the Ways of Coping Questionnaire
Avoidance Coping 6 Month Score
|
8.82 Score on a scale
Standard Deviation 5.86
|
11.85 Score on a scale
Standard Deviation 6.18
|
|
Change in the Ways of Coping Questionnaire
Avoidance Coping 9 Month Score
|
9.84 Score on a scale
Standard Deviation 5.73
|
10.89 Score on a scale
Standard Deviation 6.83
|
|
Change in the Ways of Coping Questionnaire
Avoidance Coping 12 Month Score
|
8.61 Score on a scale
Standard Deviation 6.32
|
10.54 Score on a scale
Standard Deviation 6.10
|
|
Change in the Ways of Coping Questionnaire
Minimize Coping 3 Month Score
|
11.91 Score on a scale
Standard Deviation 5.29
|
11.99 Score on a scale
Standard Deviation 5.79
|
|
Change in the Ways of Coping Questionnaire
Active Coping Baseline Score
|
22.56 Score on a scale
Standard Deviation 9.14
|
22.92 Score on a scale
Standard Deviation 10.29
|
|
Change in the Ways of Coping Questionnaire
Active Coping 3 Month Score
|
24.88 Score on a scale
Standard Deviation 8.95
|
21.52 Score on a scale
Standard Deviation 10.06
|
|
Change in the Ways of Coping Questionnaire
Active Coping 6 Month Score
|
27.36 Score on a scale
Standard Deviation 9.54
|
25.50 Score on a scale
Standard Deviation 10.66
|
|
Change in the Ways of Coping Questionnaire
Active Coping 9 Month Score
|
27.99 Score on a scale
Standard Deviation 8.71
|
27.55 Score on a scale
Standard Deviation 9.09
|
|
Change in the Ways of Coping Questionnaire
Active Coping 12 Month Score
|
26.31 Score on a scale
Standard Deviation 9.59
|
26.00 Score on a scale
Standard Deviation 10.43
|
|
Change in the Ways of Coping Questionnaire
Minimize Coping Baseline Score
|
11.78 Score on a scale
Standard Deviation 5.39
|
12.89 Score on a scale
Standard Deviation 5.64
|
|
Change in the Ways of Coping Questionnaire
Minimize Coping 6 Month Score
|
12.16 Score on a scale
Standard Deviation 4.36
|
13.87 Score on a scale
Standard Deviation 5.66
|
|
Change in the Ways of Coping Questionnaire
Minimize Coping 12 Month Score
|
12.03 Score on a scale
Standard Deviation 5.14
|
13.18 Score on a scale
Standard Deviation 5.98
|
SECONDARY outcome
Timeframe: Main analysis Baseline to 6 months. Sustainability assessed at 12 months.Population: Number of participants analyzed differs across timepoints due to participant attrition, missing data due to nonresponse, and/or missed study timepoints.
Medical Outcomes Study Short Form (SF-36): measure of physical and mental health.The SF-36 has 36 items formatted in scales of varied format (3-, 5- and 6-pt scales and dichotomous \[yes/no\] scales). Each component score is standardized a 0-100 point scale. Higher values represent better health status. Reliability is varied samples is typically 0.80. Convergent and divergent validity have been demonstrated in various populations, including caregivers. A benefit of using the SF-36 is that it is one of the common data elements.
Outcome measures
| Measure |
Intervention
n=125 Participants
Caregivers randomized to the intervention received 10 sessions of virtual health coaching by trained health coaches over 6 months. Content of the sessions was guided by the Transactional Model of Stress and Coping and prior research. Sessions were provided virtually using tablets. We called the intervention ViCCY (virtual caregiver coach for you) and sought to help caregivers gain the knowledge and skills needed to achieve their health goals through self-care. We focus on identifying personal values, solving problems, and transforming goals into action. ViCCY is standardized in a treatment manual. Because stress does not affect all people equally, the intervention is tailored to individual appraisals and the factors most likely to influence demand and perceived burden.
ViCCY: Virtual Health Coaching for You
|
Control
n=125 Participants
The control group received only Health Information (HI) delivered through the internet.
|
|---|---|---|
|
Change in Health Status as Measured by the Short Form-36 (Physical and Mental Health Status)
SF36 Physical Component Baseline Score
|
48.02 Score on a scale
Standard Deviation 10.11
|
47.25 Score on a scale
Standard Deviation 9.57
|
|
Change in Health Status as Measured by the Short Form-36 (Physical and Mental Health Status)
SF36 Physical Component 12 Month Score
|
49.10 Score on a scale
Standard Deviation 9.33
|
47.57 Score on a scale
Standard Deviation 10.95
|
|
Change in Health Status as Measured by the Short Form-36 (Physical and Mental Health Status)
SF36 Mental Component 6 Month Score
|
48.18 Score on a scale
Standard Deviation 10.43
|
42.73 Score on a scale
Standard Deviation 12.10
|
|
Change in Health Status as Measured by the Short Form-36 (Physical and Mental Health Status)
SF36 Physical Component 6 Month Score
|
47.84 Score on a scale
Standard Deviation 9.84
|
48.18 Score on a scale
Standard Deviation 9.52
|
|
Change in Health Status as Measured by the Short Form-36 (Physical and Mental Health Status)
SF36 Mental Component Baseline Score
|
43.17 Score on a scale
Standard Deviation 12.27
|
41.06 Score on a scale
Standard Deviation 12.21
|
|
Change in Health Status as Measured by the Short Form-36 (Physical and Mental Health Status)
SF36 Mental Component 12 Month Score
|
46.87 Score on a scale
Standard Deviation 11.27
|
44.33 Score on a scale
Standard Deviation 11.78
|
SECONDARY outcome
Timeframe: Measured at baseline, 3, 6, 9, and 12 months; primary analysis baseline to 12 monthsThe SF-6D uses preference weights derived from the SF-36. The Short-Form Six-Dimension (SF-6D) provides a way to use the SF-36 in economic evaluation by estimating a preference-based single index measure for health from these data using general population values. The SF-6D score represents caregiver quality of life at a given timepoint. Higher SF-6D Scores are better.
Outcome measures
| Measure |
Intervention
n=81 Participants
Caregivers randomized to the intervention received 10 sessions of virtual health coaching by trained health coaches over 6 months. Content of the sessions was guided by the Transactional Model of Stress and Coping and prior research. Sessions were provided virtually using tablets. We called the intervention ViCCY (virtual caregiver coach for you) and sought to help caregivers gain the knowledge and skills needed to achieve their health goals through self-care. We focus on identifying personal values, solving problems, and transforming goals into action. ViCCY is standardized in a treatment manual. Because stress does not affect all people equally, the intervention is tailored to individual appraisals and the factors most likely to influence demand and perceived burden.
ViCCY: Virtual Health Coaching for You
|
Control
n=85 Participants
The control group received only Health Information (HI) delivered through the internet.
|
|---|---|---|
|
Change in the Caregivers' SF-6D (Short Form Six-dimension) Scores
Baseline SF-6D
|
0.696 Score on a scale
Standard Deviation 0.105
|
0.675 Score on a scale
Standard Deviation 0.132
|
|
Change in the Caregivers' SF-6D (Short Form Six-dimension) Scores
6 Month SF-6D
|
0.733 Score on a scale
Standard Deviation 0.119
|
0.688 Score on a scale
Standard Deviation 0.128
|
|
Change in the Caregivers' SF-6D (Short Form Six-dimension) Scores
12 Month SF-6D
|
0.731 Score on a scale
Standard Deviation 0.107
|
0.690 Score on a scale
Standard Deviation 0.116
|
SECONDARY outcome
Timeframe: Data were collected at Baseline, 3, 6, 9, and 12 months. The primary analysis was done using the baseline to 12 month period.Population: At 12-months we had 209 caregivers available for the analysis; 15 were missing healthcare utilization data. We excluded 1 outlier who was in the hospital a long time. Then we had 193 in the final sample. Some of the 193 caregivers included in the analysis skipped one or two or even more follow-up interviews. However, caregivers were asked to report their healthcare utilization since the last follow-up and thus these records were able to be included in analysis.
Healthcare resource use was self-reported by caregivers when they were telephoned at each follow-up period, asking about utilization since the last interview date. The self-reported healthcare use comprised 5 major categories: hospitalizations, emergency department (ED) visits, diagnostic and therapeutic procedures, ambulance services, and home care services. A bottom-up cost account approach was used, wherein the sum of resources times their unit price yielded the total costs associated with healthcare resource use. Unit prices were measured using the 2021 Medical Expenditure Panel Survey (MEPS) (https://meps.ahrq.gov/mepsweb), an annual survey on the financing and use of medical care in the United States collected by the Agency for Healthcare Research and Quality (AHRQ).
Outcome measures
| Measure |
Intervention
n=93 Participants
Caregivers randomized to the intervention received 10 sessions of virtual health coaching by trained health coaches over 6 months. Content of the sessions was guided by the Transactional Model of Stress and Coping and prior research. Sessions were provided virtually using tablets. We called the intervention ViCCY (virtual caregiver coach for you) and sought to help caregivers gain the knowledge and skills needed to achieve their health goals through self-care. We focus on identifying personal values, solving problems, and transforming goals into action. ViCCY is standardized in a treatment manual. Because stress does not affect all people equally, the intervention is tailored to individual appraisals and the factors most likely to influence demand and perceived burden.
ViCCY: Virtual Health Coaching for You
|
Control
n=100 Participants
The control group received only Health Information (HI) delivered through the internet.
|
|---|---|---|
|
Difference in Caregivers' Hospital and Provider Events
Healthcare Cost 0-1 Month
|
59.703 Dollars
Standard Deviation 281.566
|
67.004 Dollars
Standard Deviation 379.774
|
|
Difference in Caregivers' Hospital and Provider Events
Healthcare Cost 0-3 Month
|
247.539 Dollars
Standard Deviation 1223.542
|
955.193 Dollars
Standard Deviation 4262.877
|
|
Difference in Caregivers' Hospital and Provider Events
Healthcare Cost 0-6 Month
|
1155.871 Dollars
Standard Deviation 2577.653
|
1585.167 Dollars
Standard Deviation 5448.238
|
|
Difference in Caregivers' Hospital and Provider Events
Healthcare Cost 0-9 Month
|
1347.139 Dollars
Standard Deviation 3018.211
|
2007.453 Dollars
Standard Deviation 6889.446
|
|
Difference in Caregivers' Hospital and Provider Events
Healthcare Cost 0-12 Month
|
1811.245 Dollars
Standard Deviation 3228.807
|
3121.488 Dollars
Standard Deviation 8123.811
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Count of patient hospitalizations that occurred between 6 and 12 months (following the intervention, which ended at 6 months)Population: The study sample includes 93 patients total. Because analysis focuses on patient outcomes during months 6 to 12 of the study, 4 patients were excluded from analysis of patient health outcomes due to death occurring between baseline and 6-month study timepoint. Among the remaining 89 enrolled patients, 15 did not provide sufficient data to determine whether self care improved from baseline to six months. Thus, a sample of 74 patients was analyzed.
For the 93 patients enrolled, the medical record was reviewed to capture hospitalization count. The aim was to explore the effect of caregiver outcomes (self-care) on HF patient outcomes. We hypothesize that at 12 months, HF patients whose caregivers improve vs. not improve in self-care (regardless of treatment group) will have Lower hospitalization rates. A comparison of patients' hospitalization counts which occurred between 6 and 12 month timepoints was conducted between those caregivers who exhibited a self care improvement from baseline to 6 month timepoint and those caregivers who did not exhibit a self care improvement from the baseline to 6 month timepoint.
Outcome measures
| Measure |
Intervention
n=48 Participants
Caregivers randomized to the intervention received 10 sessions of virtual health coaching by trained health coaches over 6 months. Content of the sessions was guided by the Transactional Model of Stress and Coping and prior research. Sessions were provided virtually using tablets. We called the intervention ViCCY (virtual caregiver coach for you) and sought to help caregivers gain the knowledge and skills needed to achieve their health goals through self-care. We focus on identifying personal values, solving problems, and transforming goals into action. ViCCY is standardized in a treatment manual. Because stress does not affect all people equally, the intervention is tailored to individual appraisals and the factors most likely to influence demand and perceived burden.
ViCCY: Virtual Health Coaching for You
|
Control
n=26 Participants
The control group received only Health Information (HI) delivered through the internet.
|
|---|---|---|
|
Difference in Patient Hospitalization Rate
|
0.40 Hospitalization Count
Standard Deviation 0.89
|
0.31 Hospitalization Count
Standard Deviation 0.62
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Count of patient hospitalization days which occurred between 6 and 12 month timepointsPopulation: The study sample includes 93 patients total. Because analysis focuses on patient outcomes during months 6 to 12 of the study, 4 patients were excluded from analysis of patient health outcomes due to death occurring between baseline and six month study timepoint. Among the remaining 89 enrolled patients, 15 did not provide sufficient self care data from baseline to six months. Lastly, one outlier was excluded with 148 hospital days in 6 months.A sample of 73 patients was analyzed.
For the 93 patients enrolled, the medical record was reviewed to capture hospitalization days. The aim was to explore the effect of caregiver outcomes (self-care, stress, coping, health status) on HF patient outcomes. We hypothesize that at 12 months, HF patients whose caregivers improve vs. not improve in self-care (regardless of treatment group) will have Lower hospitalization rates. A comparison of patients' hospitalization days which occurred between 6 and 12 month timepoints was conducted between those caregivers who exhibited a self care improvement from baseline to 6 month timepoint and those caregivers who did not exhibit a self care improvement from the baseline to 6 month timepoint.
Outcome measures
| Measure |
Intervention
n=48 Participants
Caregivers randomized to the intervention received 10 sessions of virtual health coaching by trained health coaches over 6 months. Content of the sessions was guided by the Transactional Model of Stress and Coping and prior research. Sessions were provided virtually using tablets. We called the intervention ViCCY (virtual caregiver coach for you) and sought to help caregivers gain the knowledge and skills needed to achieve their health goals through self-care. We focus on identifying personal values, solving problems, and transforming goals into action. ViCCY is standardized in a treatment manual. Because stress does not affect all people equally, the intervention is tailored to individual appraisals and the factors most likely to influence demand and perceived burden.
ViCCY: Virtual Health Coaching for You
|
Control
n=25 Participants
The control group received only Health Information (HI) delivered through the internet.
|
|---|---|---|
|
Patient Hospitalization Days
|
3.85 hospitalization days count
Standard Deviation 8.71
|
3.04 hospitalization days count
Standard Deviation 12.16
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Patient mortality occurring between months 6-12 of the study (following the intervention period)Population: The study sample includes 93 patients total. Because analysis focuses on patient outcomes during months 6 to 12 of the study, 4 patients were excluded from analysis of patient health outcomes due to death occurring between baseline and six month study timepoint. Among the remaining 89 enrolled patients, 15 did not provide sufficient data to determine whether self care improved from baseline to six months. Thus, a sample of 74 patients was analyzed.
For the 93 patients enrolled, the medical record was reviewed to measure mortality. The aim was to explore the effect of caregiver outcomes (self-care, stress, coping, health status) on HF patient outcomes. We hypothesize that at 12 months, HF patients whose caregivers improve vs. not improve in self-care (regardless of treatment group) would have lower mortality rates. A comparison of patient mortality occurring between 6 and 12 months was conducted between those caregivers who improved in self care during the intervention period (baseline to 6 months) and those caregivers who did not improve in self care.
Outcome measures
| Measure |
Intervention
n=48 Participants
Caregivers randomized to the intervention received 10 sessions of virtual health coaching by trained health coaches over 6 months. Content of the sessions was guided by the Transactional Model of Stress and Coping and prior research. Sessions were provided virtually using tablets. We called the intervention ViCCY (virtual caregiver coach for you) and sought to help caregivers gain the knowledge and skills needed to achieve their health goals through self-care. We focus on identifying personal values, solving problems, and transforming goals into action. ViCCY is standardized in a treatment manual. Because stress does not affect all people equally, the intervention is tailored to individual appraisals and the factors most likely to influence demand and perceived burden.
ViCCY: Virtual Health Coaching for You
|
Control
n=26 Participants
The control group received only Health Information (HI) delivered through the internet.
|
|---|---|---|
|
Patient Mortality Rates
Alive
|
47 Participants
|
26 Participants
|
|
Patient Mortality Rates
Dead
|
1 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: QALYs were measured at baseline, 3, 6, 9, and 12 months. But this analysis focused on the baseline to 12 month period.Population: 49 patients provided complete SF36 data at both baseline and 12 month timepoints.
This measure of quality adjusted life years (QALY) is derived from the SF-36. It was used in the cost-effectiveness analysis. The SF-6D uses preference weights derived from the SF-36. The Short-Form Six-Dimension (SF-6D) provides a way to use the SF-36 in economic evaluation by estimating a preference-based single index measure for health from these data using general population values. The SF-6D score represents patient quality of life at a given timepoint, while the QALY represents the area under the curve of patient quality of life from baseline to 12-month timepoints. A QALY value of one equates to one year in perfect health. Higher quality adjusted life years (QALYs) are better.
Outcome measures
| Measure |
Intervention
n=33 Participants
Caregivers randomized to the intervention received 10 sessions of virtual health coaching by trained health coaches over 6 months. Content of the sessions was guided by the Transactional Model of Stress and Coping and prior research. Sessions were provided virtually using tablets. We called the intervention ViCCY (virtual caregiver coach for you) and sought to help caregivers gain the knowledge and skills needed to achieve their health goals through self-care. We focus on identifying personal values, solving problems, and transforming goals into action. ViCCY is standardized in a treatment manual. Because stress does not affect all people equally, the intervention is tailored to individual appraisals and the factors most likely to influence demand and perceived burden.
ViCCY: Virtual Health Coaching for You
|
Control
n=16 Participants
The control group received only Health Information (HI) delivered through the internet.
|
|---|---|---|
|
Change in the Patients' Quality Adjusted Life Years (QALYs) Measured With the SF-6D (Short Form Six-dimension) Derived From the Short Form-36
|
0.67 Score on a scale
Standard Deviation 0.11
|
0.68 Score on a scale
Standard Deviation 0.1
|
Adverse Events
Intervention
Serious events: 9 serious events
Other events: 0 other events
Deaths: 0 deaths
Health Information
Serious events: 13 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention (Patient)
Serious events: 21 serious events
Other events: 0 other events
Deaths: 15 deaths
Health Information (Patient)
Serious events: 26 serious events
Other events: 0 other events
Deaths: 12 deaths
Serious adverse events
| Measure |
Intervention
n=125 participants at risk
Caregivers randomized to the intervention ViCCY will receive 10 front-loaded sessions of virtual health coaching by trained registered nurses over 6 months with content based on the theoretical framework (based on the Transactional Model of Stress and Coping) and prior research. Sessions are provided using Samsung tablets that are also programmed with health information.
For the primary aim it was hypothesized that 6 months after enrollment. the caregivers, randomized to receive the intervention would have more improvement in self-care, greater reductions in stress, greater improvement in coping and greater improvements in health status measured as the Sf. 3, 6, mental and physical component scores.
|
Health Information
n=125 participants at risk
The caregivers got augmented standard care with health information programmed on on Samsung tablets
|
Intervention (Patient)
n=29 participants at risk；n=42 participants at risk
The study also aims to explore the effect of caregiver outcomes on patient outcomes. The hypothesis is that if the caregiver is less stressed, the patient will do better. There are 42 dyads enrolled in the study associated with caregivers that were randomized to the intervention.
|
Health Information (Patient)
n=31 participants at risk；n=51 participants at risk
The study also aims to explore the effect of caregiver outcomes on patient outcomes. The hypothesis is that if the caregiver is less stressed, the patient will do better. There are 51 dyads enrolled in the study associated with caregivers that were randomized to health information.
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
COVID
|
1.6%
2/125 • Number of events 2 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
1.6%
2/125 • Number of events 2 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
0.00%
0/42 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
0.00%
0/51 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
|
Respiratory, thoracic and mediastinal disorders
RSV
|
0.00%
0/125 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
0.80%
1/125 • Number of events 1 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
0.00%
0/42 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
0.00%
0/51 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
|
General disorders
allergy
|
0.80%
1/125 • Number of events 1 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
0.00%
0/125 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
0.00%
0/42 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
0.00%
0/51 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
|
Cardiac disorders
chest pain
|
0.80%
1/125 • Number of events 1 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
0.00%
0/125 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
0.00%
0/42 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
0.00%
0/51 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
|
Gastrointestinal disorders
Complications Due to Gall Stone Surgery
|
0.00%
0/125 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
0.80%
1/125 • Number of events 1 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
0.00%
0/42 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
0.00%
0/51 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
|
Respiratory, thoracic and mediastinal disorders
COPD/Respiratory Failure
|
0.00%
0/125 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
0.80%
1/125 • Number of events 1 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
0.00%
0/42 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
2.0%
1/51 • Number of events 2 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
|
Injury, poisoning and procedural complications
Fall/fall complications
|
1.6%
2/125 • Number of events 2 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
3.2%
4/125 • Number of events 4 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
4.8%
2/42 • Number of events 2 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
7.8%
4/51 • Number of events 4 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
|
Surgical and medical procedures
gallbladder removal
|
0.80%
1/125 • Number of events 1 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
0.00%
0/125 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
0.00%
0/42 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
0.00%
0/51 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
|
General disorders
gout
|
0.00%
0/125 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
0.80%
1/125 • Number of events 1 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
0.00%
0/42 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
0.00%
0/51 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
|
Cardiac disorders
heart attack
|
0.00%
0/125 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
0.80%
1/125 • Number of events 1 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
0.00%
0/42 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
0.00%
0/51 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
|
Cardiac disorders
high blood sugar
|
0.80%
1/125 • Number of events 1 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
0.80%
1/125 • Number of events 1 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
0.00%
0/42 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
0.00%
0/51 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
0.00%
0/125 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
0.80%
1/125 • Number of events 1 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
0.00%
0/42 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
2.0%
1/51 • Number of events 1 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
|
Skin and subcutaneous tissue disorders
skin cancer
|
0.00%
0/125 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
0.80%
1/125 • Number of events 1 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
0.00%
0/42 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
0.00%
0/51 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
|
Gastrointestinal disorders
stomach flu
|
0.00%
0/125 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
0.80%
1/125 • Number of events 1 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
0.00%
0/42 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
0.00%
0/51 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
|
Cardiac disorders
stroke
|
0.00%
0/125 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
0.80%
1/125 • Number of events 1 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
0.00%
0/42 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
2.0%
1/51 • Number of events 1 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
|
General disorders
vertigo
|
0.80%
1/125 • Number of events 1 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
0.00%
0/125 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
0.00%
0/42 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
0.00%
0/51 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
|
Immune system disorders
Arthritis
|
0.00%
0/125 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
0.00%
0/125 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
0.00%
0/42 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
2.0%
1/51 • Number of events 1 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
|
Cardiac disorders
Heart Failure
|
0.00%
0/125 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
0.00%
0/125 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
28.6%
12/42 • Number of events 24 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
41.2%
21/51 • Number of events 34 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
|
Renal and urinary disorders
Kidney Injury
|
0.00%
0/125 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
0.00%
0/125 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
2.4%
1/42 • Number of events 1 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
5.9%
3/51 • Number of events 5 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/125 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
0.00%
0/125 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
2.4%
1/42 • Number of events 1 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
2.0%
1/51 • Number of events 1 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
|
Nervous system disorders
Seizure
|
0.00%
0/125 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
0.00%
0/125 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
0.00%
0/42 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
2.0%
1/51 • Number of events 1 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
|
Musculoskeletal and connective tissue disorders
Pain
|
0.00%
0/125 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
0.00%
0/125 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
2.4%
1/42 • Number of events 1 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
0.00%
0/51 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/125 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
0.00%
0/125 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
0.00%
0/42 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
2.0%
1/51 • Number of events 2 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
|
Gastrointestinal disorders
Diverticulitis
|
0.00%
0/125 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
0.00%
0/125 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
0.00%
0/42 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
3.9%
2/51 • Number of events 2 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
|
Blood and lymphatic system disorders
Hemotology
|
0.00%
0/125 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
0.00%
0/125 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
11.9%
5/42 • Number of events 5 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
7.8%
4/51 • Number of events 7 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
|
Immune system disorders
Immunology
|
0.00%
0/125 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
0.00%
0/125 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
14.3%
6/42 • Number of events 8 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
2.0%
1/51 • Number of events 1 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/125 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
0.00%
0/125 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
2.4%
1/42 • Number of events 1 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
0.00%
0/51 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
|
General disorders
Other
|
0.00%
0/125 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
2.4%
3/125 • Number of events 3 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
0.00%
0/42 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
0.00%
0/51 • Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints.
Caregiver and patient adverse event data was provided by caregivers at each study timepoint (baseline, 3-month, 6-month, 9-month, and 12-month). Caregiver self-reporting of adverse event information was verified against chart reviews performed at the 12-month. Adverse events not reported by the caregiver but discovered during chart reviews were also recorded for the caregiver and the patient.
|
Other adverse events
Adverse event data not reported
Additional Information
Barbara Riegel, PhD, RN, Professor
University of Pennsylvania
Phone: 2158989927
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place