Trial Outcomes & Findings for Atrial Fibrillation Health Literacy and Information Technology Trial (NCT NCT04075994)

Last Updated: 2024-05-30

Results Overview

Proportion of Days Covered (PDC), obtained from collection of electronic prescription and pharmacy fill data, and defined as the proportion of availability of medication for the period of interest, here the period from the date of the baseline to the 12-month examination. PDC range is 0 to 1.00 with higher values indicating greater proportion of days with medication over the 12-month period of study participation as indicated by pharmacy records.

Recruitment status

COMPLETED

Study phase

Target enrollment

243 participants

Primary outcome timeframe

12 months

Results posted on

2024-05-30

Participant Flow

Participant milestones

Participant milestones
Measure	Intervention Receive the relational agent coupled with the AliveCor Kardia heart rate and rhythm monitor for 120-day use. Relational Agent and heart rate and rhythm monitor: Use of the Relational Agent and heart rate and rhythm monitor daily for 120 days.	Usual Care Receive a brochure on atrial fibrillation, the WebMD app and the AliveCor Kardia heart rate and rhythm monitor for 120-day use. Usual Care: Use of the WebMD app and heart rate and rhythm monitor daily for 120 days.
Overall Study STARTED	123	120
Overall Study COMPLETED	110	108
Overall Study NOT COMPLETED	13	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Intervention Receive the relational agent coupled with the AliveCor Kardia heart rate and rhythm monitor for 120-day use. Relational Agent and heart rate and rhythm monitor: Use of the Relational Agent and heart rate and rhythm monitor daily for 120 days.	Usual Care Receive a brochure on atrial fibrillation, the WebMD app and the AliveCor Kardia heart rate and rhythm monitor for 120-day use. Usual Care: Use of the WebMD app and heart rate and rhythm monitor daily for 120 days.
Overall Study Withdrawal by Subject	8	9
Overall Study Adverse Event	2	2
Overall Study Investigator withdrew	3	1

Baseline Characteristics

Atrial Fibrillation Health Literacy and Information Technology Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention n=123 Participants Receive the relational agent coupled with the AliveCor Kardia heart rate and rhythm monitor for 120-day use. Relational Agent and heart rate and rhythm monitor: Use of the Relational Agent and heart rate and rhythm monitor daily for 120 days.	Usual Care n=120 Participants Receive a brochure on atrial fibrillation, the WebMD app and the AliveCor Kardia heart rate and rhythm monitor for 120-day use. Usual Care: Use of the WebMD app and heart rate and rhythm monitor daily for 120 days.	Total n=243 Participants Total of all reporting groups
Age, Continuous	71.9 years n=5 Participants	71.3 years n=7 Participants	71.7 years n=5 Participants
Sex: Female, Male Female	87 Participants n=5 Participants	69 Participants n=7 Participants	156 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants	51 Participants n=7 Participants	87 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	123 Participants n=5 Participants	117 Participants n=7 Participants	240 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	36 Participants n=5 Participants	38 Participants n=7 Participants	74 Participants n=5 Participants
Race (NIH/OMB) White	84 Participants n=5 Participants	77 Participants n=7 Participants	161 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Marital Status Never married/never lived as married	21 Participants n=5 Participants	23 Participants n=7 Participants	44 Participants n=5 Participants
Marital Status Married or living as such	62 Participants n=5 Participants	59 Participants n=7 Participants	121 Participants n=5 Participants
Marital Status Separated or divorced	15 Participants n=5 Participants	18 Participants n=7 Participants	33 Participants n=5 Participants
Marital Status Widowed	25 Participants n=5 Participants	20 Participants n=7 Participants	45 Participants n=5 Participants
Employment Status Working now, full time	13 Participants n=5 Participants	14 Participants n=7 Participants	27 Participants n=5 Participants
Employment Status Working now, part time	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Employment Status Employed but temporarily laid off	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Employment Status Sick or on leave for health reasons	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Employment Status Unemployed, looking for work	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Employment Status Unemployed, not looking for work	3 Participants n=5 Participants	8 Participants n=7 Participants	11 Participants n=5 Participants
Employment Status Homemaker, not working outside the home	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Employment Status Retired from my usual job and not working	82 Participants n=5 Participants	77 Participants n=7 Participants	159 Participants n=5 Participants
Employment Status Retired from my usual job but working for pay	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants
Total family income Less than or equal to $19,999	17 Participants n=5 Participants	12 Participants n=7 Participants	29 Participants n=5 Participants
Total family income $20,000 to $34,999	15 Participants n=5 Participants	20 Participants n=7 Participants	35 Participants n=5 Participants
Total family income $35,000 to $49,999	14 Participants n=5 Participants	18 Participants n=7 Participants	32 Participants n=5 Participants
Total family income $50,000 to $74,999	22 Participants n=5 Participants	17 Participants n=7 Participants	39 Participants n=5 Participants
Total family income $75,000 to $99,999	14 Participants n=5 Participants	13 Participants n=7 Participants	27 Participants n=5 Participants
Total family income Greater than or equal to $100,000	16 Participants n=5 Participants	18 Participants n=7 Participants	34 Participants n=5 Participants
Total family income Don't know	13 Participants n=5 Participants	9 Participants n=7 Participants	22 Participants n=5 Participants
Total family income Prefer not to respond	12 Participants n=5 Participants	13 Participants n=7 Participants	25 Participants n=5 Participants
Education Some high school with no certificate	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Education High school graduate	22 Participants n=5 Participants	25 Participants n=7 Participants	47 Participants n=5 Participants
Education Some vocational/trade school with no certificate	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Education Vocational/trade certificate	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Education Some college with no degree	20 Participants n=5 Participants	22 Participants n=7 Participants	42 Participants n=5 Participants
Education Associate degree	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Education Bachelor degree	20 Participants n=5 Participants	17 Participants n=7 Participants	37 Participants n=5 Participants
Education Graduate/professional school	29 Participants n=5 Participants	21 Participants n=7 Participants	50 Participants n=5 Participants
Education Unknown	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Type of medical insurance None	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Type of medical insurance Medicaid	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Type of medical insurance Medicare	13 Participants n=5 Participants	12 Participants n=7 Participants	25 Participants n=5 Participants
Type of medical insurance Private	32 Participants n=5 Participants	36 Participants n=7 Participants	68 Participants n=5 Participants
Type of medical insurance Other	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Type of medical insurance Medicaid/Medicare	11 Participants n=5 Participants	8 Participants n=7 Participants	19 Participants n=5 Participants
Type of medical insurance Medicaid/Tricare	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Type of medical insurance Medicaid/Private	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Type of medical insurance Medicare/Tricare	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Type of medical insurance Medicare/Private	52 Participants n=5 Participants	55 Participants n=7 Participants	107 Participants n=5 Participants
Type of medical insurance Medicare/Other	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Type of medical insurance Tricare/Private	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Type of medical insurance Private/Other	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Type of medical insurance Great than 2 types	6 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants
Approximate years with Atrial Fibrillation	4 years n=5 Participants	4 years n=7 Participants	4 years n=5 Participants
Warfarin or Direct-acting oral anticoagulant Warfarin (also called Coumadin, Jantoven)	19 Participants n=5 Participants	15 Participants n=7 Participants	34 Participants n=5 Participants
Warfarin or Direct-acting oral anticoagulant Xarelto (Rivaroxaban)	30 Participants n=5 Participants	23 Participants n=7 Participants	53 Participants n=5 Participants
Warfarin or Direct-acting oral anticoagulant Pradaxa (Dabigatran)	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Warfarin or Direct-acting oral anticoagulant Eliquis (Apixaban)	73 Participants n=5 Participants	81 Participants n=7 Participants	154 Participants n=5 Participants
Non-adherence to oral anticoagulation Yes	16 Participants n=5 Participants	17 Participants n=7 Participants	33 Participants n=5 Participants
Non-adherence to oral anticoagulation No	107 Participants n=5 Participants	103 Participants n=7 Participants	210 Participants n=5 Participants
AF Effect on Quality of Life Overall Score	74.1 units on a scale n=5 Participants	73.6 units on a scale n=7 Participants	74.1 units on a scale n=5 Participants
AF Effect on Quality of Life Symptoms Score	87.5 units on a scale n=5 Participants	91.7 units on a scale n=7 Participants	91.7 units on a scale n=5 Participants
AF Effect on Quality of Life Daily Activities Score	66.7 units on a scale n=5 Participants	65.6 units on a scale n=7 Participants	66.7 units on a scale n=5 Participants
AF Effect on Quality of Life Treatment Concerns Score	83.3 units on a scale n=5 Participants	80.6 units on a scale n=7 Participants	80.6 units on a scale n=5 Participants
AF Effect on Quality of Life Satisfaction with how well your current treatment controls your AF	83.3 units on a scale n=5 Participants	83.3 units on a scale n=7 Participants	83.3 units on a scale n=5 Participants
AF Effect on Quality of Life Satisfaction with the extent that treatment has relieved your symptoms of AF	83.3 units on a scale n=5 Participants	83.3 units on a scale n=7 Participants	83.3 units on a scale n=5 Participants
Patient-Reported Outcomes Measurement Information System 29 item instrument (PROMIS-29)-29 Physical Function (T-score)	40.5 Score on a scale n=5 Participants	43.5 Score on a scale n=7 Participants	41.9 Score on a scale n=5 Participants
Patient-Reported Outcomes Measurement Information System 29 item instrument (PROMIS-29)-29 Anxiety (T-score)	40.3 Score on a scale n=5 Participants	48.0 Score on a scale n=7 Participants	48.0 Score on a scale n=5 Participants
Patient-Reported Outcomes Measurement Information System 29 item instrument (PROMIS-29)-29 Depression (T-score)	41.0 Score on a scale n=5 Participants	41.0 Score on a scale n=7 Participants	41.0 Score on a scale n=5 Participants
Patient-Reported Outcomes Measurement Information System 29 item instrument (PROMIS-29)-29 Fatigue (T-score)	51.0 Score on a scale n=5 Participants	51.0 Score on a scale n=7 Participants	51.0 Score on a scale n=5 Participants
Patient-Reported Outcomes Measurement Information System 29 item instrument (PROMIS-29)-29 Sleep Disturbance (T-score)	50.5 Score on a scale n=5 Participants	50.5 Score on a scale n=7 Participants	50.5 Score on a scale n=5 Participants
Patient-Reported Outcomes Measurement Information System 29 item instrument (PROMIS-29)-29 Ability to Participate in Social Roles and Activities (T-score)	51.9 Score on a scale n=5 Participants	51.9 Score on a scale n=7 Participants	51.9 Score on a scale n=5 Participants
Patient-Reported Outcomes Measurement Information System 29 item instrument (PROMIS-29)-29 Pain Interference (T-score)	55.6 Score on a scale n=5 Participants	53.9 Score on a scale n=7 Participants	53.9 Score on a scale n=5 Participants
Patient-Reported Outcomes Measurement Information System 29 item instrument (PROMIS-29)-29 Pain Intensity (Global07)	3 Score on a scale n=5 Participants	3 Score on a scale n=7 Participants	3 Score on a scale n=5 Participants
Health literacy High likelihood of limited health literacy	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Health literacy Possibility of limited health literacy	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Health literacy Adequate health literacy	73 Participants n=5 Participants	70 Participants n=7 Participants	143 Participants n=5 Participants
Brief Health Literacy Screening Instrument Limited	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Brief Health Literacy Screening Instrument Moderate	14 Participants n=5 Participants	27 Participants n=7 Participants	41 Participants n=5 Participants
Brief Health Literacy Screening Instrument Adequate	102 Participants n=5 Participants	85 Participants n=7 Participants	187 Participants n=5 Participants
Patient Health Questionnaire-8	3 units on a scale n=5 Participants	3 units on a scale n=7 Participants	3 units on a scale n=5 Participants
Underwent prior electrophysiologic procedure Underwent electrical cardioversion · No	91 Participants n=5 Participants	81 Participants n=7 Participants	172 Participants n=5 Participants
Underwent prior electrophysiologic procedure Underwent electrical cardioversion · Yes	32 Participants n=5 Participants	39 Participants n=7 Participants	71 Participants n=5 Participants
Underwent prior electrophysiologic procedure Underwent medication cardioversion · No	121 Participants n=5 Participants	118 Participants n=7 Participants	239 Participants n=5 Participants
Underwent prior electrophysiologic procedure Underwent medication cardioversion · Yes	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Underwent prior electrophysiologic procedure Underwent a pacemaker insertion · No	107 Participants n=5 Participants	100 Participants n=7 Participants	207 Participants n=5 Participants
Underwent prior electrophysiologic procedure Underwent a pacemaker insertion · Yes	16 Participants n=5 Participants	20 Participants n=7 Participants	36 Participants n=5 Participants
Underwent prior electrophysiologic procedure Underwent a defibrillator insertion · No	115 Participants n=5 Participants	110 Participants n=7 Participants	225 Participants n=5 Participants
Underwent prior electrophysiologic procedure Underwent a defibrillator insertion · Yes	8 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants
Underwent prior electrophysiologic procedure Underwent a pulmonary vein isolation · No	123 Participants n=5 Participants	120 Participants n=7 Participants	243 Participants n=5 Participants
Underwent prior electrophysiologic procedure Underwent a pulmonary vein isolation · Yes	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Body Mass Index (BMI)	31.7 Weight (kg) / Height^2(m^2) n=5 Participants	29.9 Weight (kg) / Height^2(m^2) n=7 Participants	31.2 Weight (kg) / Height^2(m^2) n=5 Participants
General Health Excellent	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
General Health Very Good	28 Participants n=5 Participants	32 Participants n=7 Participants	60 Participants n=5 Participants
General Health Good	48 Participants n=5 Participants	47 Participants n=7 Participants	95 Participants n=5 Participants
General Health Fair	34 Participants n=5 Participants	29 Participants n=7 Participants	63 Participants n=5 Participants
General Health Poor	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Smoking History Ever smoked cigarettes · No	49 Participants n=5 Participants	58 Participants n=7 Participants	107 Participants n=5 Participants
Smoking History Ever smoked cigarettes · Yes	73 Participants n=5 Participants	62 Participants n=7 Participants	135 Participants n=5 Participants
Smoking History Ever smoked cigarettes · Prefer not to respond	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Smoking History Currently smoke · No	114 Participants n=5 Participants	107 Participants n=7 Participants	221 Participants n=5 Participants
Smoking History Currently smoke · Yes	8 Participants n=5 Participants	13 Participants n=7 Participants	21 Participants n=5 Participants
Smoking History Currently smoke · Prefer not to respond	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Montreal Cognitive Assessment Score less than 19	13 Participants n=5 Participants	8 Participants n=7 Participants	21 Participants n=5 Participants
Montreal Cognitive Assessment Score greater than or equal to 19	33 Participants n=5 Participants	37 Participants n=7 Participants	70 Participants n=5 Participants
Montreal Cognitive Assessment Not assessed	77 Participants n=5 Participants	75 Participants n=7 Participants	152 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Pharmacy data were not available for 8 intervention and 7 usual care participants.

Outcome measures

Outcome measures
Measure	Intervention n=115 Participants Receive the relational agent coupled with the AliveCor Kardia heart rate and rhythm monitor for 120-day use. Relational Agent and heart rate and rhythm monitor: Use of the Relational Agent and heart rate and rhythm monitor daily for 120 days.	Usual Care n=113 Participants Receive a brochure on atrial fibrillation, the WebMD app and the AliveCor Kardia heart rate and rhythm monitor for 120-day use. Usual Care: Use of the WebMD app and heart rate and rhythm monitor daily for 120 days.
Proportion of Days Covered	1.0 Proportion of days covered Interval 0.9 to 1.0	0.9 Proportion of days covered Interval 0.8 to 1.0

SECONDARY outcome

Timeframe: 4, 8 and 12 months

Population: Intervention 4-month: n=111 (11 withdrawals \[w/d\]; 1 missed visit) 8-month: n=109 (total 13 w/d; 1 missed visit) 12-month: n= 108 (total 13 w/d; 2 missed the visit) Usual care 4-months: n=107 (10 w/d; 3 missed visit) 8 months: n=107 (total 10 w/d; 3 missed visit) 12-months: n=103 (total 12 w/d; 5 missed visit)

Self-reported non-adherence to oral anticoagulation with a 3-item instrument with each item scored 1-5 and lower scores indicating adherence. Scores dichotomized to classify participants as adherent (indicated by reporting 1 on all 3 items) or as non-adherent (indicated by reporting ≥ 2 on any of the 3 items).

Outcome measures

Outcome measures
Measure	Intervention n=123 Participants Receive the relational agent coupled with the AliveCor Kardia heart rate and rhythm monitor for 120-day use. Relational Agent and heart rate and rhythm monitor: Use of the Relational Agent and heart rate and rhythm monitor daily for 120 days.	Usual Care n=120 Participants Receive a brochure on atrial fibrillation, the WebMD app and the AliveCor Kardia heart rate and rhythm monitor for 120-day use. Usual Care: Use of the WebMD app and heart rate and rhythm monitor daily for 120 days.
Self-reported Non-adherence 4 Month · Adherent	99 Participants	87 Participants
Self-reported Non-adherence 4 Month · Non-adherent	12 Participants	20 Participants
Self-reported Non-adherence 8 Month · Adherent	99 Participants	87 Participants
Self-reported Non-adherence 8 Month · Non-adherent	10 Participants	20 Participants
Self-reported Non-adherence 12 Month · Adherent	94 Participants	85 Participants
Self-reported Non-adherence 12 Month · Non-adherent	14 Participants	18 Participants

SECONDARY outcome

Timeframe: 4, 8, and 12 months

Population: Intervention arm: 4-month: n=111 (11 withdrawals \[w/d\]; 1 missed visit) 8-month: n=109 (total 13 w/d; 1 missed visit) 12-month: n=108 (total 13 w/d; 2 missed visit) Usual Care: 4-month: n=107 (10 w/d; 3 missed visit) 8-month: n=107 (total 10 w/d; 3 missed visit) 12-month: n=103 (total 12 w/d; 5 missed visit)

Measure Description: Patient-Reported Outcomes Measurement Information System (PROMIS)-29 assesses 7 domains (physical function; depression and sadness; pain interference; satisfaction with participation in social roles and activities; fatigue; anxiety and fear; sleep disturbance), 4 questions each, and Pain Intensity with a single item. The 7 domain scores are transformed using a T-score with a mean of 50, standard deviation of 10, in a referent population. Higher scores indicate worse health for the depression, pain, fatigue, anxiety/sleep domains, while higher scores indicate better health for the physical function and satisfaction domains. The single Pain Intensity item is scored 0 (No pain) to 10 (Worst imaginable pain) in the past 7 days. Further details on PROMIS scoring are available at https://www.healthmeasures.net/images/PROMIS/manuals/PROMIS\_Adult\_Profile\_Scoring\_Manual.pdf.

Outcome measures

Outcome measures
Measure	Intervention n=123 Participants Receive the relational agent coupled with the AliveCor Kardia heart rate and rhythm monitor for 120-day use. Relational Agent and heart rate and rhythm monitor: Use of the Relational Agent and heart rate and rhythm monitor daily for 120 days.	Usual Care n=120 Participants Receive a brochure on atrial fibrillation, the WebMD app and the AliveCor Kardia heart rate and rhythm monitor for 120-day use. Usual Care: Use of the WebMD app and heart rate and rhythm monitor daily for 120 days.
Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Physical Function: 8 month	41.9 Score on a scale Interval 36.7 to 48.3	41.9 Score on a scale Interval 35.6 to 57.0
Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Anxiety: 4 month	40.3 Score on a scale Interval 40.3 to 53.7	48.0 Score on a scale Interval 40.3 to 55.8
Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Fatigue: 12 month	48.6 Score on a scale Interval 46.0 to 57.0	48.6 Score on a scale Interval 43.1 to 57.0
Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Pain Interference: 12 month	55.6 Score on a scale Interval 41.6 to 61.2	55.6 Score on a scale Interval 41.6 to 62.5
Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Pain Intensity (Global 07): 4 month	4 Score on a scale Interval 1.0 to 63.0	3 Score on a scale Interval 1.0 to 6.0
Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Depression: 4 month	41.0 Score on a scale Interval 41.0 to 51.8	41.0 Score on a scale Interval 14.0 to 51.8
Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Depression:8 month	41.0 Score on a scale Interval 41.0 to 49.0	41.0 Score on a scale Interval 41.0 to 51.8
Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Depression: 12 month	41.0 Score on a scale Interval 41.0 to 51.8	41.0 Score on a scale Interval 41.0 to 51.8
Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Fatigue: 4 month	51.0 Score on a scale Interval 46.0 to 57.0	53.1 Score on a scale Interval 43.1 to 58.8
Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Fatigue: 8 month	51.0 Score on a scale Interval 46.0 to 57.0	51.0 Score on a scale Interval 43.1 to 58.8
Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Sleep Disturbance: 4 month	48.4 Score on a scale Interval 43.8 to 54.3	50.5 Score on a scale Interval 41.1 to 56.1
Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Sleep Disturbance: 8 month	48.4 Score on a scale Interval 41.1 to 54.3	50.5 Score on a scale Interval 43.8 to 56.1
Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Sleep Disturbance: 12 month	48.4 Score on a scale Interval 43.8 to 54.3	50.5 Score on a scale Interval 41.1 to 56.1
Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Ability to Participate in Social Roles and Activities: 4 month	51.9 Score on a scale Interval 44.2 to 64.2	51.9 Score on a scale Interval 44.2 to 64.2
Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Ability to Participate in Social Roles and Activities: 8 month	51.9 Score on a scale Interval 44.2 to 58.3	51.9 Score on a scale Interval 44.2 to 58.3
Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Ability to Participate in Social Roles and Activities: 12 month	51.0 Score on a scale Interval 44.2 to 58.3	51.9 Score on a scale Interval 44.2 to 64.2
Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Pain Interference: 4 month	57.1 Score on a scale Interval 41.6 to 62.5	55.6 Score on a scale Interval 41.6 to 61.2
Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Pain Interference: 8 month	55.6 Score on a scale Interval 41.6 to 61.2	55.6 Score on a scale Interval 41.6 to 61.2
Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Pain Intensity (Global 07): 8 month	3 Score on a scale Interval 1.0 to 5.0	3 Score on a scale Interval 1.0 to 5.0
Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Pain Intensity (Global 07): 12 month	4 Score on a scale Interval 2.0 to 6.0	3 Score on a scale Interval 1.0 to 6.0
Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Physical Function: 4 month	41.9 Score on a scale Interval 35.6 to 48.3	41.9 Score on a scale Interval 36.7 to 57.0
Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Physical Function: 12 month	41.9 Score on a scale Interval 36.7 to 48.3	43.5 Score on a scale Interval 36.7 to 57.0
Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Anxiety: 8 month	40.3 Score on a scale Interval 40.3 to 53.7	48.0 Score on a scale Interval 40.3 to 55.8
Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Anxiety: 12 month	40.3 Score on a scale Interval 40.3 to 53.7	40.3 Score on a scale Interval 40.3 to 53.7

SECONDARY outcome

Timeframe: 4, 8 and 12 months

The Atrial Fibrillation Effect on Quality of life (AFEQT) is a widely used measure of atrial fibrillation-specific health-related quality of life. Scores range from 0 to 100 with higher scores indicating superior health-related quality of life in AF.

Outcome measures

Outcome measures
Measure	Intervention n=123 Participants Receive the relational agent coupled with the AliveCor Kardia heart rate and rhythm monitor for 120-day use. Relational Agent and heart rate and rhythm monitor: Use of the Relational Agent and heart rate and rhythm monitor daily for 120 days.	Usual Care n=120 Participants Receive a brochure on atrial fibrillation, the WebMD app and the AliveCor Kardia heart rate and rhythm monitor for 120-day use. Usual Care: Use of the WebMD app and heart rate and rhythm monitor daily for 120 days.
Atrial Fibrillation Effect on Quality of Life (AFEQT) 4 Month	77.8 score on a scale Interval 61.1 to 93.5	79.6 score on a scale Interval 60.2 to 92.6
Atrial Fibrillation Effect on Quality of Life (AFEQT) 8 Month	79.6 score on a scale Interval 65.7 to 91.7	77.8 score on a scale Interval 63.9 to 91.7
Atrial Fibrillation Effect on Quality of Life (AFEQT) 12 Month	76.9 score on a scale Interval 66.2 to 92.6	82.4 score on a scale Interval 62.0 to 92.6

SECONDARY outcome

Timeframe: 12 months

Population: Intervention: n=112 (11 withdrawals prior to month-4 visit, date of first collection of this outcome) Usual care n=110 (10 withdrawals prior to month-4 visit, date of first collection of this outcome)

The number of emergency room visits and hospitalizations quantified at 12 months.

Outcome measures

Outcome measures
Measure	Intervention n=112 Participants Receive the relational agent coupled with the AliveCor Kardia heart rate and rhythm monitor for 120-day use. Relational Agent and heart rate and rhythm monitor: Use of the Relational Agent and heart rate and rhythm monitor daily for 120 days.	Usual Care n=110 Participants Receive a brochure on atrial fibrillation, the WebMD app and the AliveCor Kardia heart rate and rhythm monitor for 120-day use. Usual Care: Use of the WebMD app and heart rate and rhythm monitor daily for 120 days.
Emergency Room (ER) Visits and Hospitalizations	71 ER visits or hospitalization events	163 ER visits or hospitalization events

SECONDARY outcome

Timeframe: 12 months

The number of days of hospitalization ascertained from extraction of electronic health records through the 12 months of study duration. Total days spent in hospital over 12 months were summarized as a single count for each participant.

Outcome measures

Outcome measures
Measure	Intervention n=112 Participants Receive the relational agent coupled with the AliveCor Kardia heart rate and rhythm monitor for 120-day use. Relational Agent and heart rate and rhythm monitor: Use of the Relational Agent and heart rate and rhythm monitor daily for 120 days.	Usual Care n=110 Participants Receive a brochure on atrial fibrillation, the WebMD app and the AliveCor Kardia heart rate and rhythm monitor for 120-day use. Usual Care: Use of the WebMD app and heart rate and rhythm monitor daily for 120 days.
Days of Hospitalization	292 days	638 days

Adverse Events

Intervention

Serious events: 30 serious events

Other events: 18 other events

Deaths: 2 deaths

Usual Care

Serious events: 26 serious events

Other events: 26 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

Additional Information

Dr. Jared Magnani

University of Pittsburgh

Phone: (412)383-0611

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Intervention n=123 participants at risk Receive the relational agent coupled with the AliveCor Kardia heart rate and rhythm monitor for 120-day use. Relational Agent and heart rate and rhythm monitor: Use of the Relational Agent and heart rate and rhythm monitor daily for 120 days.	Usual Care n=120 participants at risk Receive a brochure on atrial fibrillation, the WebMD app and the AliveCor Kardia heart rate and rhythm monitor for 120-day use. Usual Care: Use of the WebMD app and heart rate and rhythm monitor daily for 120 days.
Cardiac disorders Heart failure	13.0% 16/123 • Number of events 18 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	10.0% 12/120 • Number of events 21 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
Cardiac disorders Atrial fibrillation	2.4% 3/123 • Number of events 3 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	5.8% 7/120 • Number of events 12 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
Cardiac disorders Chest pain-cardiac	3.3% 4/123 • Number of events 4 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	0.00% 0/120 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
Cardiac disorders Cardiac arrest	0.00% 0/123 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	0.83% 1/120 • Number of events 2 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
Cardiac disorders Myocardial infarction	1.6% 2/123 • Number of events 2 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	0.00% 0/120 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
Cardiac disorders Aortic valve disease	0.81% 1/123 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	0.00% 0/120 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
Cardiac disorders Atrial flutter	0.81% 1/123 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	0.00% 0/120 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
Cardiac disorders Atrioventricular block first degree	0.00% 0/123 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	0.83% 1/120 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
Cardiac disorders Coronary Artery Disease	0.00% 0/123 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	0.83% 1/120 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
Cardiac disorders Pericarditis	0.00% 0/123 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	0.83% 1/120 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
Cardiac disorders Sinus bradycardia	0.00% 0/123 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	0.83% 1/120 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
General disorders COVID-19	2.4% 3/123 • Number of events 3 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	2.5% 3/120 • Number of events 3 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
General disorders Death NOS	1.6% 2/123 • Number of events 2 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	0.00% 0/120 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
General disorders Edema limbs	0.00% 0/123 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	0.83% 1/120 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
General disorders Fatigue	0.81% 1/123 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	0.00% 0/120 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
General disorders Ambulatory dysfunction	0.81% 1/123 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	0.00% 0/120 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
General disorders Non-cardiac chest pain	0.00% 0/123 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	0.83% 1/120 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
General disorders Pain	0.00% 0/123 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	0.83% 1/120 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.81% 1/123 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	0.83% 1/120 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.81% 1/123 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	0.83% 1/120 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/123 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	0.83% 1/120 • Number of events 2 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/123 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	0.83% 1/120 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
Respiratory, thoracic and mediastinal disorders COPD exacerbation	0.00% 0/123 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	0.83% 1/120 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
Respiratory, thoracic and mediastinal disorders Stridor	0.81% 1/123 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	0.00% 0/120 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
Ear and labyrinth disorders Vertigo	0.81% 1/123 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	0.00% 0/120 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
Respiratory, thoracic and mediastinal disorders Tracheal stenosis	0.81% 1/123 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	0.00% 0/120 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
Respiratory, thoracic and mediastinal disorders Wheezing	0.81% 1/123 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	0.00% 0/120 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
Gastrointestinal disorders Abdominal pain	0.81% 1/123 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	2.5% 3/120 • Number of events 3 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
Gastrointestinal disorders Colonic hemorrhage	0.00% 0/123 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	0.83% 1/120 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
Gastrointestinal disorders Acute upper GI bleed	0.81% 1/123 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	0.00% 0/120 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
Gastrointestinal disorders Hematochezia	0.00% 0/123 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	0.83% 1/120 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
Gastrointestinal disorders Rectal hemorrhage	0.00% 0/123 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	0.83% 1/120 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
Gastrointestinal disorders Small intestinal obstruction	0.81% 1/123 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	0.00% 0/120 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
Nervous system disorders Intracranial hemorrhage	0.81% 1/123 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	0.83% 1/120 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
Nervous system disorders Stroke	0.00% 0/123 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	1.7% 2/120 • Number of events 2 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
Nervous system disorders Transient ischemic attacks	0.00% 0/123 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	1.7% 2/120 • Number of events 2 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
Nervous system disorders Movements involuntary	0.81% 1/123 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	0.00% 0/120 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
Nervous system disorders Syncope	0.00% 0/123 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	0.83% 1/120 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
Metabolism and nutrition disorders Hypoglycemia	0.00% 0/123 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	1.7% 2/120 • Number of events 3 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/123 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	0.83% 1/120 • Number of events 2 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.

Other adverse events
Measure	Intervention n=123 participants at risk Receive the relational agent coupled with the AliveCor Kardia heart rate and rhythm monitor for 120-day use. Relational Agent and heart rate and rhythm monitor: Use of the Relational Agent and heart rate and rhythm monitor daily for 120 days.	Usual Care n=120 participants at risk Receive a brochure on atrial fibrillation, the WebMD app and the AliveCor Kardia heart rate and rhythm monitor for 120-day use. Usual Care: Use of the WebMD app and heart rate and rhythm monitor daily for 120 days.
Cardiac disorders Chest pain-cardiac	0.00% 0/123 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	1.7% 2/120 • Number of events 6 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
Cardiac disorders Atrial fibrillation	1.6% 2/123 • Number of events 2 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	2.5% 3/120 • Number of events 3 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
Cardiac disorders Atrial flutter	0.81% 1/123 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	0.00% 0/120 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
Cardiac disorders Elevated blood pressure	0.81% 1/123 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	0.00% 0/120 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
Cardiac disorders Palpitations	0.00% 0/123 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	0.83% 1/120 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
Injury, poisoning and procedural complications Fall	2.4% 3/123 • Number of events 3 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	1.7% 2/120 • Number of events 5 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
Injury, poisoning and procedural complications Bruising	0.00% 0/123 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	0.83% 1/120 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
Injury, poisoning and procedural complications Fracture	0.00% 0/123 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	0.83% 1/120 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
Injury, poisoning and procedural complications Bleeding varicose vein	0.81% 1/123 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	0.00% 0/120 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
Musculoskeletal and connective tissue disorders Pain in extremity	1.6% 2/123 • Number of events 2 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	1.7% 2/120 • Number of events 3 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
Musculoskeletal and connective tissue disorders Arthritis	0.81% 1/123 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	0.83% 1/120 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/123 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	0.83% 1/120 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
Musculoskeletal and connective tissue disorders Chest wall pain	0.81% 1/123 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	0.00% 0/120 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
Musculoskeletal and connective tissue disorders Impaired mobility	0.00% 0/123 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	0.83% 1/120 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
Musculoskeletal and connective tissue disorders Neck pain	0.81% 1/123 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	0.00% 0/120 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
Gastrointestinal disorders Abdominal pain	0.00% 0/123 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	2.5% 3/120 • Number of events 4 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
Gastrointestinal disorders Nausea	0.00% 0/123 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	0.83% 1/120 • Number of events 2 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
Gastrointestinal disorders Mucositis oral	0.00% 0/123 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	0.83% 1/120 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
Gastrointestinal disorders Rectal hemorrhage	0.00% 0/123 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	0.83% 1/120 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
Gastrointestinal disorders Vomiting	0.00% 0/123 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	0.83% 1/120 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/123 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	4.2% 5/120 • Number of events 6 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/123 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	0.83% 1/120 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.81% 1/123 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	0.00% 0/120 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/123 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	0.83% 1/120 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
General disorders Pain	0.81% 1/123 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	1.7% 2/120 • Number of events 2 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
General disorders Fatigue	0.00% 0/123 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	0.83% 1/120 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
General disorders Flu like symptoms	0.81% 1/123 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	0.00% 0/120 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
General disorders Right leg pain	0.00% 0/123 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	0.83% 1/120 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
General disorders Shortness of breath	0.00% 0/123 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	0.83% 1/120 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
General disorders Viral syndrome	0.00% 0/123 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	0.83% 1/120 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
Vascular disorders Hypertension	0.81% 1/123 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	0.83% 1/120 • Number of events 3 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
Vascular disorders Hypotension	0.81% 1/123 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	0.00% 0/120 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
Nervous system disorders Dizziness	0.81% 1/123 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	0.00% 0/120 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
Nervous system disorders Peripheral motor neuropathy	0.00% 0/123 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	0.83% 1/120 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
Nervous system disorders Presyncope	0.00% 0/123 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	0.83% 1/120 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
Nervous system disorders Transient ischemic attacks	0.00% 0/123 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	0.83% 1/120 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
Blood and lymphatic system disorders Anemia	0.00% 0/123 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	1.7% 2/120 • Number of events 3 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
Infections and infestations Bronchial infection	0.00% 0/123 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	0.83% 1/120 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
Infections and infestations Joint infection	0.00% 0/123 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	0.83% 1/120 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
Infections and infestations Upper respiratory infection	0.00% 0/123 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.	0.83% 1/120 • Number of events 1 • Data collection occurred from date of consent through the participants 12-month visit. The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.