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| ID | Type | Description | Link |
|---|---|---|---|
| 6292-2020-R2TC-T12T13 | Other Grant/Funding Number | Medical Device Innovation Consortium, on behalf of the NESTcc |
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| Name | Class |
|---|---|
| Mayo Clinic | OTHER |
| Duke University | OTHER |
| National Evaluation System for health Technology Coordinating Center | OTHER |
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This will be a prospective multi-center, randomized, controlled trial of 150 patients conducted to assess the impact of individual use of the Apple Watch compared to the Withings Move on patient-reported and clinical outcomes at 6 months and up to 1 year.
This is a a randomized, controlled trial to determine the impact of the Apple Watch Series 6 compared to the Withings Move on both patient-reported outcomes and clinical utilization over 6 months and up to 1 year. Our research method will employ a patient-centered health data sharing platform (called Hugo) for real-world surveillance of outcomes in 150 total patients after they receive elective direct current cardioversion (DCCV) or catheter ablation for treatment of atrial fibrillation or atrial flutter. Patients will be enrolled at each of 3 clinical sites: Yale-New Haven Hospital, the Mayo Clinic, and Duke Health. Half of the patients will be randomized to receive the Apple Watch Series 6, while half will receive a control device (Withings Move). Patients will then be queried about specific symptoms related to atrial fibrillation and medication adherence monthly. This project will provide novel and needed post-market data about the Apple Watch Series 6 ECG and irregular rhythm detection notification features and, on a larger scale, help delineate the impact of an innovative digital health technology on real-world patient outcomes.
Specific Aim 1: To assess the impact of using the Apple Watch ECG and irregular rhythm notification features on patient-reported outcomes and clinical utilization after patients receive cardioversion or catheter ablation for atrial fibrillation or atrial flutter.
Specific Aim 2: To determine the accuracy of the Apple Watch ECG compared to physician interpretation of 12-lead ECGs obtained in routine clinical care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apple Watch | Experimental | Patients will be provided with the Apple Watch Series 6 with Irregular Rhythm Detection and ECG capabilities. |
|
| Withings Move | Placebo Comparator | Patients will be provided with the Withings Move with activity tracking. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apple Watch | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) | 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. | baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) | 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. | baseline and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Ross, MD, MHS | Yale University | Principal Investigator |
| Peter Noseworthy, MD | Mayo Clinic | Principal Investigator |
| Sreekanth Vemulapalli, MD | Duke University | Principal Investigator |
| Sanket Dhruva, MD, MHS | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale-New Haven Hospital | New Haven | Connecticut | 06510 | United States | ||
| Mayo Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35234659 | Derived | Dhruva SS, Shah ND, Vemulapalli S, Deshmukh A, Beatty AL, Gamble GM, Freeman JV, Hummel JP, Piccini JP, Akar JG, Ervin K, Arges KL, Emanuel L, Noseworthy PA, Hu T, Bartlett V, Ross JS. Heart Watch Study: protocol for a pragmatic randomised controlled trial. BMJ Open. 2021 Dec 30;11(12):e054550. doi: 10.1136/bmjopen-2021-054550. |
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Once the study has been completed, IPD will be shared in a way which will protect patient confidentiality using a data sharing platform for research purposes
Data will become available once the study has been completed.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) | 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. | Number of patients that completed the AFEQT questionnaire at 6 months | Posted | Mean | 95% Confidence Interval | score on a scale | baseline and 6 months |
|
Adverse event data was collected over 12 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joseph Ross, MD, MHS | Yale University | 2037852987 | joseph.ross@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 17, 2023 | Nov 26, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 11, 2022 | Nov 19, 2024 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 17, 2023 | Nov 19, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| Withings Move | Device | 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 | 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 | 6 months |
| Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) Domain- Symptoms | 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 | 12 months |
| Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) Domain- Daily Activities | 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 | 6 months |
| Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) Domain- Daily Activities | 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 | 12 months |
| Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) Domain- Treatment Concern | 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 | 6 months |
| Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) Domain- Treatment Concern | 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 | 12 months |
| Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) Domain- Treatment Satisfaction | 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 | 6 months |
| Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) Domain- Treatment Satisfaction | 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 | 12 months |
| Proportion of Patients Taking Anticoagulants | Anticoagulation use will be assessed at 6 months using the Brief Medication Questionnaire to trend patients' monthly responses about anticoagulation use | 6 months |
| Proportion of Patients Taking Anticoagulants | Anticoagulation use will be assessed at 12 months using the Brief Medication Questionnaire to trend patients' monthly responses about anticoagulation use | 12 months |
| Proportion of Participants With Acute Care Use at 6 Months | 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. | 6 months |
| Proportion of Participants With Acute Care Use at 12 Months | 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. | 12 months |
| Proportion of Participants With Outpatient Care Use at 6 Months | 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. | 6 months |
| Proportion of Participants With Outpatient Care Use at 12 Months | 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. | 12 months |
| Proportion of Participants With Rhythm-related Diagnostic Testing at 6 Months | Rhythm-related diagnostic testing will be assessed at 6 month including total ECGs and total outpatient heart rhythm monitors | 6 months |
| Proportion of Participants With Rhythm-related Diagnostic Testing at 12 Months | Rhythm-related diagnostic testing will be assessed at 12 month including total ECGs and total outpatient heart rhythm monitors | 12 months |
| Proportion of Participants With Clinical Treatment for Atrial Fibrillation or Flutter | 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. | 6 months |
| Proportion of Participants With Clinical Treatment for Atrial Fibrillation or Flutter | 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. | 12 months |
| Rochester |
| Minnesota |
| 55905 |
| United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 | 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. |
|
|
| Secondary | Change in Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) | 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. | Number of patients that completed the AFEQT questionnaire at 12 months | Posted | Mean | 95% Confidence Interval | score on a scale | baseline and 12 months |
|
|
|
| Secondary | Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) Domain- Symptoms | 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 | Number of patients that completed the AFEQT Questionnaire at 6 months | Posted | Mean | 95% Confidence Interval | score on a scale | 6 months |
|
|
|
| Secondary | Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) Domain- Symptoms | 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 | Number of patients that completed the AFEQT questionnaire at 12 months | Posted | Mean | 95% Confidence Interval | score on a scale | 12 months |
|
|
|
| Secondary | Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) Domain- Daily Activities | 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 | Number of patients that completed the AFEQT Questionnaire at 6 months | Posted | Mean | 95% Confidence Interval | score on a scale | 6 months |
|
|
|
| Secondary | Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) Domain- Daily Activities | 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 | Number of patients that completed the AFEQT questionnaire at 12 months | Posted | Mean | 95% Confidence Interval | score on a scale | 12 months |
|
|
|
| Secondary | Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) Domain- Treatment Concern | 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 | Number of patients that completed the AFEQT Questionnaire at 6 months | Posted | Mean | 95% Confidence Interval | score on a scale | 6 months |
|
|
|
| Secondary | Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) Domain- Treatment Concern | 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 | Number of patients that completed the AFEQT questionnaire at 12 months | Posted | Mean | 95% Confidence Interval | score on a scale | 12 months |
|
|
|
| Secondary | Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) Domain- Treatment Satisfaction | 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 | Number of patients that completed the AFEQT Questionnaire at 6 months | Posted | Mean | 95% Confidence Interval | score on a scale | 6 months |
|
|
|
| Secondary | Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) Domain- Treatment Satisfaction | 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 | Number of patients that completed the AFEQT questionnaire at 12 months | Posted | Mean | 95% Confidence Interval | score on a scale | 12 months |
|
|
|
| Secondary | Proportion of Patients Taking Anticoagulants | Anticoagulation use will be assessed at 6 months using the Brief Medication Questionnaire to trend patients' monthly responses about anticoagulation use | Responses were received for n=84 participants. Data were missing for n=21 participants. | Posted | Number | percentage of patients | 6 months |
|
|
|
| Secondary | Proportion of Patients Taking Anticoagulants | Anticoagulation use will be assessed at 12 months using the Brief Medication Questionnaire to trend patients' monthly responses about anticoagulation use | Responses were received for n=55 participants. Data were missing for n=50 participants. | Posted | Number | percentage of patients | 12 months |
|
|
|
| Secondary | Proportion of Participants With Acute Care Use at 6 Months | 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. | 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. | Posted | 6 months |
|
|
| Secondary | Proportion of Participants With Acute Care Use at 12 Months | 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. | 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. | Posted | 12 months |
|
|
| Secondary | Proportion of Participants With Outpatient Care Use at 6 Months | 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. | 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. | Posted | 6 months |
|
|
| Secondary | Proportion of Participants With Outpatient Care Use at 12 Months | 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. | 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. | Posted | 12 months |
|
|
| Secondary | Proportion of Participants With Rhythm-related Diagnostic Testing at 6 Months | Rhythm-related diagnostic testing will be assessed at 6 month including total ECGs and total outpatient heart rhythm monitors | 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. | Posted | 6 months |
|
|
| Secondary | Proportion of Participants With Rhythm-related Diagnostic Testing at 12 Months | Rhythm-related diagnostic testing will be assessed at 12 month including total ECGs and total outpatient heart rhythm monitors | 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. | Posted | 12 months |
|
|
| Secondary | Proportion of Participants With Clinical Treatment for Atrial Fibrillation or Flutter | 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. | 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. | Posted | 6 months |
|
|
| Secondary | Proportion of Participants With Clinical Treatment for Atrial Fibrillation or Flutter | 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. | 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. | Posted | 12 months |
|
|
| 0 |
| 70 |
| 0 |
| 70 |
| 0 |
| 70 |
| EG001 | 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. | 0 | 35 | 0 | 35 | 0 | 35 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |