Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Corewell Health West | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telehealth | Experimental | Participants will be provided with a smartwatch, have access to activity tracking and goal setting through the VALENTINE app, receive micro-randomized, contextually tailored notifications, and receive weekly activity summaries via email, which will be provided to participants and to their exercise physiologist while enrolled in cardiac rehabilitation. |
|
| Control | Active Comparator | Participants will continue to receive usual care and a smartwatch but without access to the micro-randomized notifications or weekly activity summaries. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telehealth | Behavioral | Participants will receive weekly activity summaries and tailored notifications about their activity and goal setting behaviors. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in 6-minute walk distance | 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. | Baseline, 6-months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in average step count | 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. | Baseline, 6-months |
| Measure | Description | Time Frame |
|---|---|---|
| Proximal outcome for activity notifications. | The proximal outcome for activity notifications will be average step count 1-hour after a notification measured by smartwatch. | 1-hour after an activity notification, up to 6-months. |
| Proximal outcome for exercise notifications. |
Inclusion criteria:
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.
Age > 18 and < 75
Owns an Android or iPhone with study supported operating software.
Understands English to enable informed consent, completion of study-related surveys, and compliance with study notifications.
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):
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Brahmajee K Nallamothu | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States | ||
| Spectrum Health |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38887953 | Derived | Golbus JR, Shi J, Gupta K, Stevens R, Jeganathan VSE, Luff E, Boyden T, Mukherjee B, Kohnstamm S, Taralunga V, Kheterpal V, Kheterpal S, Resnicow K, Murphy S, Dempsey W, Klasnja P, Nallamothu BK. Text Messages to Promote Physical Activity in Patients With Cardiovascular Disease: A Micro-Randomized Trial of a Just-In-Time Adaptive Intervention. Circ Cardiovasc Qual Outcomes. 2024 Jul;17(7):e010731. doi: 10.1161/CIRCOUTCOMES.123.010731. Epub 2024 Jun 18. | |
| 38226512 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D017216 | Telemedicine |
| ID | Term |
|---|---|
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
Not provided
Not provided
A prospective, randomized-controlled trial where the primary purpose is secondary prevention.
Not provided
Not provided
Not provided
Not provided
| Control | Behavioral | Participants will get usual care and wear a smartwatch. |
|
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. |
| The day after an exercise notification, up to 6-months. |
| All-cause mortality and Cardiovascular mortality | The event numbers will be added together | 6-months |
| All-cause mortality and Cardiovascular mortality | The event numbers will be added together | 12-months |
| Cardiovascular hospitalizations | 6-months |
| Cardiovascular hospitalizations | 12-months |
| Change in 6-minute walk distance | 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. | Baseline, 3-months |
| Change in 6-minute walk distance, subgroup analysis | 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. | Baseline and 6-months |
| Change in average step count, subgroup analysis | 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. | Baseline and 6-months |
| Subgroup analyses of micro-randomized notifications by notification type | 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. | 6-months |
| Grand Rapids |
| Michigan |
| 49525 |
| United States |
| Derived |
| Atluri N, Mishra SR, Anderson T, Stevens R, Edwards A, Luff E, Nallamothu BK, Golbus JR. Acceptability of a Text Message-Based Mobile Health Intervention to Promote Physical Activity in Cardiac Rehabilitation Enrollees: A Qualitative Substudy of Participant Perspectives. J Am Heart Assoc. 2024 Jan 16;13(2):e030807. doi: 10.1161/JAHA.123.030807. Epub 2024 Jan 16. |
| 35559648 | Derived | Golbus JR, Gupta K, Stevens R, Jeganathan VS, Luff E, Boyden T, Mukherjee B, Klasnja P, Kheterpal S, Kohnstamm S, Nallamothu BK. Understanding Baseline Physical Activity in Cardiac Rehabilitation Enrollees Using Mobile Health Technologies. Circ Cardiovasc Qual Outcomes. 2022 Jul;15(7):e009182. doi: 10.1161/CIRCOUTCOMES.122.009182. Epub 2022 May 13. |
| 35235834 | Derived | Jeganathan VS, Golbus JR, Gupta K, Luff E, Dempsey W, Boyden T, Rubenfire M, Mukherjee B, Klasnja P, Kheterpal S, Nallamothu BK. Virtual AppLication-supported Environment To INcrease Exercise (VALENTINE) during cardiac rehabilitation study: Rationale and design. Am Heart J. 2022 Jun;248:53-62. doi: 10.1016/j.ahj.2022.02.012. Epub 2022 Feb 27. |