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Trial Outcomes & Findings for Heart Watch Study: a Pragmatic Randomized Controlled Trial (NCT NCT04468321)

NCT ID: NCT04468321

Last Updated: 2025-04-18

Results Overview

Change in the Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) questionnaire global score at 6 months compared to baseline between the Apple Watch and patients randomized to the Withings Move arm at 6 months compared to baseline. Reported on a scale from 0 to 100 with a higher score indicating a better outcome.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

105 participants

Primary outcome timeframe

baseline and 6 months

Results posted on

2025-04-18

Participant Flow

Participant milestones

Participant milestones
Measure
Apple Watch
Patients will be provided with the Apple Watch Series 6 with Irregular Rhythm Detection and ECG capabilities. Apple Watch: Participants will be assigned to the Apple Watch arm to assess the impact of individual use of the Apple Watch on patient-reported and clinical utilization outcomes using Hugo.
Withings Move
Patients will be provided with the Withings Move with activity tracking. Withings Move: Participants will be assigned to the Withings Move arm to assess the impact of individual use of the Withings Move on patient-reported and clinical utilization outcomes using Hugo.
Overall Study
STARTED
70
35
Overall Study
COMPLETED
60
25
Overall Study
NOT COMPLETED
10
10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Heart Watch Study: a Pragmatic Randomized Controlled Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Apple Watch
n=70 Participants
Patients will be provided with the Apple Watch Series 6 with Irregular Rhythm Detection and ECG capabilities. Apple Watch: Participants will be assigned to the Apple Watch arm to assess the impact of individual use of the Apple Watch on patient-reported and clinical utilization outcomes using Hugo.
Withings Move
n=35 Participants
Patients will be provided with the Withings Move with activity tracking. Withings Move: Participants will be assigned to the Withings Move arm to assess the impact of individual use of the Withings Move on patient-reported and clinical utilization outcomes using Hugo.
Total
n=105 Participants
Total of all reporting groups
Age, Continuous
65.2 years
STANDARD_DEVIATION 10.22 • n=5 Participants
70.3 years
STANDARD_DEVIATION 9.55 • n=7 Participants
66.9 years
STANDARD_DEVIATION 10.24 • n=5 Participants
Sex: Female, Male
Female
19 Participants
n=5 Participants
10 Participants
n=7 Participants
29 Participants
n=5 Participants
Sex: Female, Male
Male
51 Participants
n=5 Participants
25 Participants
n=7 Participants
76 Participants
n=5 Participants
Race/Ethnicity, Customized
Race/Ethnicity · American Indian or Alaska Native
1 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
Race/Ethnicity, Customized
Race/Ethnicity · Black or African American
2 Participants
n=5 Participants
3 Participants
n=7 Participants
5 Participants
n=5 Participants
Race/Ethnicity, Customized
Race/Ethnicity · Black or African American and White
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Race/Ethnicity, Customized
Race/Ethnicity · White
67 Participants
n=5 Participants
31 Participants
n=7 Participants
98 Participants
n=5 Participants

PRIMARY outcome

Timeframe: baseline and 6 months

Population: Number of patients that completed the AFEQT questionnaire at 6 months

Change in the Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) questionnaire global score at 6 months compared to baseline between the Apple Watch and patients randomized to the Withings Move arm at 6 months compared to baseline. Reported on a scale from 0 to 100 with a higher score indicating a better outcome.

Outcome measures

Outcome measures
Measure
Apple Watch
n=60 Participants
Patients will be provided with the Apple Watch Series 6 with Irregular Rhythm Detection and ECG capabilities. Apple Watch: Participants will be assigned to the Apple Watch arm to assess the impact of individual use of the Apple Watch on patient-reported and clinical utilization outcomes using Hugo.
Withings Move
n=25 Participants
Patients will be provided with the Withings Move with activity tracking. Withings Move: Participants will be assigned to the Withings Move arm to assess the impact of individual use of the Withings Move on patient-reported and clinical utilization outcomes using Hugo.
Change in Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life)
20.3 score on a scale
Interval 14.7 to 25.8
17.9 score on a scale
Interval 8.6 to 27.2

SECONDARY outcome

Timeframe: baseline and 12 months

Population: Number of patients that completed the AFEQT questionnaire at 12 months

Change in the Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) questionnaire global score at 12 months compared to baseline between the Apple Watch and patients randomized to the Withings Move arm at 12 months compared to baseline. Reported on a scale from 0 to 100 with a higher score indicating a better outcome.

Outcome measures

Outcome measures
Measure
Apple Watch
n=43 Participants
Patients will be provided with the Apple Watch Series 6 with Irregular Rhythm Detection and ECG capabilities. Apple Watch: Participants will be assigned to the Apple Watch arm to assess the impact of individual use of the Apple Watch on patient-reported and clinical utilization outcomes using Hugo.
Withings Move
n=12 Participants
Patients will be provided with the Withings Move with activity tracking. Withings Move: Participants will be assigned to the Withings Move arm to assess the impact of individual use of the Withings Move on patient-reported and clinical utilization outcomes using Hugo.
Change in Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life)
23.5 score on a scale
Interval 16.6 to 30.4
25.0 score on a scale
Interval 11.0 to 39.1

SECONDARY outcome

Timeframe: 6 months

Population: Number of patients that completed the AFEQT Questionnaire at 6 months

Difference within individual Symptoms domain of the Atrial Fibrillation Effect on QualiTy-of-life questionnaire between patients randomized to the Apple Watch and patients randomized to the Withings Move arm over the 6-month period. Reported on a scale from 0 to 100 with a higher score indicating a better outcome

Outcome measures

Outcome measures
Measure
Apple Watch
n=60 Participants
Patients will be provided with the Apple Watch Series 6 with Irregular Rhythm Detection and ECG capabilities. Apple Watch: Participants will be assigned to the Apple Watch arm to assess the impact of individual use of the Apple Watch on patient-reported and clinical utilization outcomes using Hugo.
Withings Move
n=25 Participants
Patients will be provided with the Withings Move with activity tracking. Withings Move: Participants will be assigned to the Withings Move arm to assess the impact of individual use of the Withings Move on patient-reported and clinical utilization outcomes using Hugo.
Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) Domain- Symptoms
21.8 score on a scale
Interval 14.0 to 29.5
13.1 score on a scale
Interval 6.0 to 20.2

SECONDARY outcome

Timeframe: 12 months

Population: Number of patients that completed the AFEQT questionnaire at 12 months

Difference within individual Symptom domain of the Atrial Fibrillation Effect on QualiTy-of-life questionnaire between patients randomized to the Apple Watch and patients randomized to the Withings Move arm over the 12-month period. Reported on a scale from 0 to 100 with a higher score indicating a better outcome

Outcome measures

Outcome measures
Measure
Apple Watch
n=43 Participants
Patients will be provided with the Apple Watch Series 6 with Irregular Rhythm Detection and ECG capabilities. Apple Watch: Participants will be assigned to the Apple Watch arm to assess the impact of individual use of the Apple Watch on patient-reported and clinical utilization outcomes using Hugo.
Withings Move
n=12 Participants
Patients will be provided with the Withings Move with activity tracking. Withings Move: Participants will be assigned to the Withings Move arm to assess the impact of individual use of the Withings Move on patient-reported and clinical utilization outcomes using Hugo.
Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) Domain- Symptoms
23.7 score on a scale
Interval 15.8 to 31.6
25.3 score on a scale
Interval 10.5 to 40.1

SECONDARY outcome

Timeframe: 6 months

Population: Number of patients that completed the AFEQT Questionnaire at 6 months

Difference within individual Daily Activities domain of the Atrial Fibrillation Effect on QualiTy-of-life questionnaire between patients randomized to the Apple Watch and patients randomized to the Withings Move arm over the 6-month period. Reported on a scale from 0 to 100 with a higher score indicating a better outcome

Outcome measures

Outcome measures
Measure
Apple Watch
n=60 Participants
Patients will be provided with the Apple Watch Series 6 with Irregular Rhythm Detection and ECG capabilities. Apple Watch: Participants will be assigned to the Apple Watch arm to assess the impact of individual use of the Apple Watch on patient-reported and clinical utilization outcomes using Hugo.
Withings Move
n=24 Participants
Patients will be provided with the Withings Move with activity tracking. Withings Move: Participants will be assigned to the Withings Move arm to assess the impact of individual use of the Withings Move on patient-reported and clinical utilization outcomes using Hugo.
Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) Domain- Daily Activities
22.1 score on a scale
Interval 14.7 to 29.5
20.5 score on a scale
Interval 8.6 to 32.4

SECONDARY outcome

Timeframe: 12 months

Population: Number of patients that completed the AFEQT questionnaire at 12 months

Difference within individual Daily Activities domain of the Atrial Fibrillation Effect on QualiTy-of-life questionnaire between patients randomized to the Apple Watch and patients randomized to the Withings Move arm over the 12-month period. Reported on a scale from 0 to 100 with a higher score indicating a better outcome

Outcome measures

Outcome measures
Measure
Apple Watch
n=42 Participants
Patients will be provided with the Apple Watch Series 6 with Irregular Rhythm Detection and ECG capabilities. Apple Watch: Participants will be assigned to the Apple Watch arm to assess the impact of individual use of the Apple Watch on patient-reported and clinical utilization outcomes using Hugo.
Withings Move
n=12 Participants
Patients will be provided with the Withings Move with activity tracking. Withings Move: Participants will be assigned to the Withings Move arm to assess the impact of individual use of the Withings Move on patient-reported and clinical utilization outcomes using Hugo.
Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) Domain- Daily Activities
27.2 score on a scale
Interval 18.4 to 36.0
27.2 score on a scale
Interval 8.2 to 46.2

SECONDARY outcome

Timeframe: 6 months

Population: Number of patients that completed the AFEQT Questionnaire at 6 months

Difference within individual Treatment Concern domain of the Atrial Fibrillation Effect on QualiTy-of-life questionnaire between patients randomized to the Apple Watch and patients randomized to the Withings Move arm over the 6-month period. Reported on a scale from 0 to 100 with a higher score indicating a better outcome

Outcome measures

Outcome measures
Measure
Apple Watch
n=60 Participants
Patients will be provided with the Apple Watch Series 6 with Irregular Rhythm Detection and ECG capabilities. Apple Watch: Participants will be assigned to the Apple Watch arm to assess the impact of individual use of the Apple Watch on patient-reported and clinical utilization outcomes using Hugo.
Withings Move
n=24 Participants
Patients will be provided with the Withings Move with activity tracking. Withings Move: Participants will be assigned to the Withings Move arm to assess the impact of individual use of the Withings Move on patient-reported and clinical utilization outcomes using Hugo.
Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) Domain- Treatment Concern
17.1 score on a scale
Interval 11.4 to 22.7
21.0 score on a scale
Interval 10.5 to 31.5

SECONDARY outcome

Timeframe: 12 months

Population: Number of patients that completed the AFEQT questionnaire at 12 months

Difference within individual Treatment Concern domain of the Atrial Fibrillation Effect on QualiTy-of-life questionnaire between patients randomized to the Apple Watch and patients randomized to the Withings Move arm over the 12-month period. Reported on a scale from 0 to 100 with a higher score indicating a better outcome

Outcome measures

Outcome measures
Measure
Apple Watch
n=43 Participants
Patients will be provided with the Apple Watch Series 6 with Irregular Rhythm Detection and ECG capabilities. Apple Watch: Participants will be assigned to the Apple Watch arm to assess the impact of individual use of the Apple Watch on patient-reported and clinical utilization outcomes using Hugo.
Withings Move
n=12 Participants
Patients will be provided with the Withings Move with activity tracking. Withings Move: Participants will be assigned to the Withings Move arm to assess the impact of individual use of the Withings Move on patient-reported and clinical utilization outcomes using Hugo.
Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) Domain- Treatment Concern
17.6 score on a scale
Interval 10.0 to 25.2
21.9 score on a scale
Interval 8.6 to 35.3

SECONDARY outcome

Timeframe: 6 months

Population: Number of patients that completed the AFEQT Questionnaire at 6 months

Difference within individual Treatment Satisfaction domain of the Atrial Fibrillation Effect on QualiTy-of-life questionnaire between patients randomized to the Apple Watch and patients randomized to the Withings Move arm over the 6-month period. Reported on a scale from 0 to 100 with a higher score indicating a better outcome

Outcome measures

Outcome measures
Measure
Apple Watch
n=59 Participants
Patients will be provided with the Apple Watch Series 6 with Irregular Rhythm Detection and ECG capabilities. Apple Watch: Participants will be assigned to the Apple Watch arm to assess the impact of individual use of the Apple Watch on patient-reported and clinical utilization outcomes using Hugo.
Withings Move
n=24 Participants
Patients will be provided with the Withings Move with activity tracking. Withings Move: Participants will be assigned to the Withings Move arm to assess the impact of individual use of the Withings Move on patient-reported and clinical utilization outcomes using Hugo.
Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) Domain- Treatment Satisfaction
19.3 score on a scale
Interval 12.0 to 26.6
11.1 score on a scale
Interval -5.2 to 27.4

SECONDARY outcome

Timeframe: 12 months

Population: Number of patients that completed the AFEQT questionnaire at 12 months

Difference within individual Treatment Satisfaction domain of the Atrial Fibrillation Effect on QualiTy-of-life questionnaire between patients randomized to the Apple Watch and patients randomized to the Withings Move arm over the 12-month period. Reported on a scale from 0 to 100 with a higher score indicating a better outcome

Outcome measures

Outcome measures
Measure
Apple Watch
n=42 Participants
Patients will be provided with the Apple Watch Series 6 with Irregular Rhythm Detection and ECG capabilities. Apple Watch: Participants will be assigned to the Apple Watch arm to assess the impact of individual use of the Apple Watch on patient-reported and clinical utilization outcomes using Hugo.
Withings Move
n=12 Participants
Patients will be provided with the Withings Move with activity tracking. Withings Move: Participants will be assigned to the Withings Move arm to assess the impact of individual use of the Withings Move on patient-reported and clinical utilization outcomes using Hugo.
Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) Domain- Treatment Satisfaction
25.5 score on a scale
Interval 16.9 to 34.2
25.0 score on a scale
Interval 2.3 to 47.6

SECONDARY outcome

Timeframe: 6 months

Population: Responses were received for n=84 participants. Data were missing for n=21 participants.

Anticoagulation use will be assessed at 6 months using the Brief Medication Questionnaire to trend patients' monthly responses about anticoagulation use

Outcome measures

Outcome measures
Measure
Apple Watch
n=60 Participants
Patients will be provided with the Apple Watch Series 6 with Irregular Rhythm Detection and ECG capabilities. Apple Watch: Participants will be assigned to the Apple Watch arm to assess the impact of individual use of the Apple Watch on patient-reported and clinical utilization outcomes using Hugo.
Withings Move
n=24 Participants
Patients will be provided with the Withings Move with activity tracking. Withings Move: Participants will be assigned to the Withings Move arm to assess the impact of individual use of the Withings Move on patient-reported and clinical utilization outcomes using Hugo.
Proportion of Patients Taking Anticoagulants
98.3 percentage of patients
91.6 percentage of patients

SECONDARY outcome

Timeframe: 12 months

Population: Responses were received for n=55 participants. Data were missing for n=50 participants.

Anticoagulation use will be assessed at 12 months using the Brief Medication Questionnaire to trend patients' monthly responses about anticoagulation use

Outcome measures

Outcome measures
Measure
Apple Watch
n=43 Participants
Patients will be provided with the Apple Watch Series 6 with Irregular Rhythm Detection and ECG capabilities. Apple Watch: Participants will be assigned to the Apple Watch arm to assess the impact of individual use of the Apple Watch on patient-reported and clinical utilization outcomes using Hugo.
Withings Move
n=12 Participants
Patients will be provided with the Withings Move with activity tracking. Withings Move: Participants will be assigned to the Withings Move arm to assess the impact of individual use of the Withings Move on patient-reported and clinical utilization outcomes using Hugo.
Proportion of Patients Taking Anticoagulants
90.6 percentage of patients
91.6 percentage of patients

SECONDARY outcome

Timeframe: 6 months

Population: The emergency department visits, observation stays, and all hospitalizations data were not collected due to broken connections between the data aggregating platform and the participant's electronic health record. The team did not discover this until after the participant follow-up period concluded.

Acute care use will be compared between the two groups at 6 months. Acute care is defined as an emergency department visits, observation stays, and all hospitalizations over the 6 month period.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Population: The emergency department visits, observation stays, and all hospitalizations data were not collected due to broken connections between the data aggregating platform and the participant's electronic health record. The team did not discover this until after the participant follow-up period concluded.

Acute care use will be compared between the two groups at 12 months. Acute care is defined as an emergency department visits, observation stays, and all hospitalizations over the 12 month period.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: The outpatient primary care visits, outpatient cardiology or cardiac electrophysiology visits, and scheduled telephone encounters data were not collected due to broken connections between the data aggregating platform and the participant's electronic health record. The team did not discover this until after the participant follow-up period concluded.

Outpatient care use will be compared between the two groups at 6 months. Outpatient care is defined as outpatient primary care visits, outpatient cardiology or cardiac electrophysiology visits, and scheduled telephone encounters.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Population: The outpatient primary care visits, outpatient cardiology or cardiac electrophysiology visits, and scheduled telephone encounters data were not collected due to broken connections between the data aggregating platform and the participant's electronic health record. The team did not discover this until after the participant follow-up period concluded.

Outpatient care use will be compared between the two groups at 12 months. Outpatient care is defined as outpatient primary care visits, outpatient cardiology or cardiac electrophysiology visits, and scheduled telephone encounters.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: The total ECGs and total outpatient heart rhythm monitors data were not collected due to broken connections between the data aggregating platform and the participant's electronic health record. The team did not discover this until after the participant follow-up period concluded.

Rhythm-related diagnostic testing will be assessed at 6 month including total ECGs and total outpatient heart rhythm monitors

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Population: The total ECGs and total outpatient heart rhythm monitors data were not collected due to broken connections between the data aggregating platform and the participant's electronic health record. The team did not discover this until after the participant follow-up period concluded.

Rhythm-related diagnostic testing will be assessed at 12 month including total ECGs and total outpatient heart rhythm monitors

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: The medication data were not collected due to broken connections between the data aggregating platform and the participant's electronic health record. The team did not discover this until after the participant follow-up period concluded.

A composite outcome of rhythm control intervention, which is defined as at least one additional cardioversion, initiation of antiarrhythmic medical therapy, dose escalation of antiarrhythmic medication, change to another antiarrhythmic medication, or ablation for atrial fibrillation over the 6 month period. The medication data will be obtained primarily from electronic health record data.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Population: The medication data were not collected due to broken connections between the data aggregating platform and the participant's electronic health record. The team did not discover this until after the participant follow-up period concluded.

A composite outcome of rhythm control intervention, which is defined as at least one additional cardioversion, initiation of antiarrhythmic medical therapy, dose escalation of antiarrhythmic medication, change to another antiarrhythmic medication, or ablation for atrial fibrillation over the 12 month period. The medication data will be obtained primarily from electronic health record data.

Outcome measures

Outcome data not reported

Adverse Events

Apple Watch

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Withings Move

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Joseph Ross, MD, MHS

Yale University

Phone: 2037852987

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place