Virtual AppLication-supported ENvironment To INcrease Exercise During Cardiac Rehabilitation Study
Condition: Heart Diseases; Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases; Heart Diseases
Study type: Interventional

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.
    

Intervention name(s): Telehealth; Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will receive weekly activity summaries and tailored notifications about their activity and goal setting behaviors.; Participants will get usual care and wear a smartwatch.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A prospective, randomized-controlled trial where the primary purpose is secondary prevention.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Cardiac rehabilitation