Cardiovascular Diseases, Heart Diseases
Conditions
Keywords
Cardiac rehabilitation
Brief summary
The researchers are trying to determine whether a smartwatch and a mobile application, which together deliver activity and goal setting notifications, can increase activity levels for patients enrolled in cardiac rehabilitation.
Detailed description
The VALENTINE Cardiac Rehabilitation Study will evaluate a digital intervention to supplement cardiac rehabilitation for low- and moderate risk patients, integrating a mobile application with physiologic and contextual information from wearables to provide incremental support to patients. The study will be performed in conjunction with planned home-, hybrid-, or center-based cardiac rehabilitation at Michigan Medicine. Participants will be randomized to the control or telehealth group. Both groups will receive a smartwatch and usual care. Participants in the telehealth arm will additionally (1) have access to activity tracking and goal setting through the VALENTINE app; (2) receive micro-randomized, contextually tailored notifications, and (3) receive weekly activity summaries via email, which will also be provided to their exercise physiologist while enrolled in cardiac rehabilitation. Contextually tailored notifications will be one of two types: walking and exercise notifications. Walking notifications are designed to encourage participants to be active though at lower than their target heart rate zone. Participants will receive 1 notification per day, on average, at one of four times. Notifications will be randomized on four dimensions of context. Exercise notifications are designed to encourage participants to exercise within their target heart rate zone. Notifications will be delivered each evening at a time of the participant's choosing. Participants will have a 50% probability of receiving a notification each evening. Notifications will be randomized on two dimensions of context. Participants will be followed for 6-months. Participants in both arms will be asked to complete a 6-minute walk test at baseline, 3-months, and 6-months using their mobile phone and smartwatch. They will additionally complete general and disease-specific quality-of-life questionnaires at baseline and at 6-months. To account for potential measurement error between devices, for primary and secondary analyses, we will perform regression analysis to jointly test the null hypothesis H0: B0(F) = B0(A) = 0 for change between baseline and 6 months where (F) and (A) refer to Fitbit and Apple watches respectively. A secondary analysis will subsequently be performed to determine whether to reject the individual null hypotheses for each of the two devices. For all statistical analyses, the level of significance will be set at p \<0.05.
Interventions
BEHAVIORALTelehealth
Participants will receive weekly activity summaries and tailored notifications about their activity and goal setting behaviors.
BEHAVIORALControl
Participants will get usual care and wear a smartwatch.
Sponsors
Corewell Health West
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
A prospective, randomized-controlled trial where the primary purpose is secondary prevention.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Must be a patient within the Michigan Medicine clinical system with data available in the electronic health record after January 1, 2013. Spectrum Health patients may participate if they have a Michigan Medicine MRN and data is available through connected electronic health records. 2. Age \> 18 and \< 75 3. Owns an Android or iPhone with study supported operating software. 4. Understands English to enable informed consent, completion of study-related surveys, and compliance with study notifications. 5. Enrolled in cardiac rehabilitation within the past 8-weeks based on one of the following indications (listed below) and has completed at least 2 cardiac rehabilitation sessions (includes orientation session; to remain in the study, participants in the hybrid program must complete at least one additional exercise session for a minimum of 2 center-based rehabilitation sessions): * Coronary artery disease (including acute coronary syndromes and stable angina) following percutaneous coronary intervention (PCI) * Coronary artery disease following coronary artery bypass surgery (CABG)\] * Valve repair or replacement (either surgical or percutaneous) * Coronary artery disease or an acute coronary syndrome not requiring revascularization
Exclusion criteria
1. Orthopedic or neurological condition limiting ability to actively engage in exercise training session 2. Greater than mild cognitive impairment 3. Wrist too large to wear a smartwatch comfortably. This will be assessed by asking participants If they have ever had difficulty wearing a watch in the past due to the band being too small. 4. Currently receiving palliative care and/or in hospice care 5. Severe valvular stenosis or regurgitation 6. Unrevascularized left main coronary artery disease (\> 50% obstruction on angiography) or proximal left anterior descending disease (\>70% obstruction on angiography). 7. Exercise-induced ventricular tachycardia 8. Cardiac arrest within the prior 6 months 9. New York Heart Association (NYHA) class III or IV heart failure 10. Pulmonary arterial hypertension treated with inhaled or intravenous pulmonary hypertension-specific therapy 11. Ejection fraction \<40% 12. Determined to be unsafe for participation in this program to augment cardiac rehabilitation as assessed by a clinical nurse or investigative team.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in 6-minute walk distance | Baseline, 6-months | 6-minute walk distance is determined by the 6-minute walk test recorded using a mobile phone paired with a smartwach and recorded in meters. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in average step count | Baseline, 6-months | Change in average step count as determined by smartwatch. Baseline average is the average step count from the first 7 days of wearing the smartwatch. The 6-month average step count is the daily average step count over one week at 6-months. |
Other
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality and Cardiovascular mortality | 6-months | The event numbers will be added together |
| Cardiovascular hospitalizations | 6-months | — |
| Change in 6-minute walk distance | Baseline, 3-months | 6-minute walk distance is determined by the 6-minute walk test recorded using a mobile phone paired with a smartwach and recorded in meters. |
| Proximal outcome for activity notifications. | 1-hour after an activity notification, up to 6-months. | The proximal outcome for activity notifications will be average step count 1-hour after a notification measured by smartwatch. |
| Change in average step count, subgroup analysis | Baseline and 6-months | Change in average step count as determined by smartwatch. Baseline average is the average step count from the first 7 days of wearing the smartwatch. The 6-month average step count is the daily average step count over one week at 6-months. Outcome measures stratified by type of cardiac rehabilitation, age, gender, baseline walk distance, and comfort with digital technology. |
| Subgroup analyses of micro-randomized notifications by notification type | 6-months | Subgroup analyses will be performed to determine which notification types are most effective based on the following features: Loss versus gain framework; Emoji versus no emoji in message; Message personalized with name versus no name ; Message includes hyperlink to study dashboard versus no hyperlink; Message encourages an activity versus anti-sedentary behavior. |
| Change in 6-minute walk distance, subgroup analysis | Baseline and 6-months | 6-minute walk distance is determined by the 6-minute walk test recorded using a mobile phone paired with a smartwach and recorded in meters. Outcome measures will be stratified by type of cardiac rehabilitation, duration of cardiac rehabilitation, age, gender, baseline walk distance, and comfort with digital technology. |
| Proximal outcome for exercise notifications. | The day after an exercise notification, up to 6-months. | The proximal outcome for exercise notifications will be exercise minutes the day after a notification, defined as the number of fairly active and very active minutes on smartwatch. |
Countries
United States
Outcome results
None listed