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Virtual AppLication-supported ENvironment To INcrease Exercise During Cardiac Rehabilitation Study (VALENTINE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04587882
Recruitment Status : Not yet recruiting
First Posted : October 14, 2020
Last Update Posted : October 14, 2020
Sponsor:
Information provided by (Responsible Party):
Brahmajee K Nallamothu, University of Michigan

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.

Condition or disease Intervention/treatment Phase
Heart Diseases Cardiovascular Diseases Behavioral: Telehealth Behavioral: Control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
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
Official Title: Virtual AppLication-supported ENvironment To INcrease Exercise During Cardiac Rehabilitation Study
Estimated Study Start Date : October 2020
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Telehealth
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.
Behavioral: Telehealth
Participants will receive weekly activity summaries and tailored notifications about their activity and goal setting behaviors.

Active Comparator: Control
Participants will continue to receive usual care and a smartwatch but without access to the micro-randomized notifications or weekly activity summaries.
Behavioral: Control
Participants will get usual care and wear a smartwatch.




Primary Outcome Measures :
  1. Change in 6-minute walk distance [ Time Frame: 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 Outcome Measures :
  1. Change in average step count [ Time Frame: 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 Outcome Measures:
  1. Proximal outcome for activity notifications. [ Time Frame: 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.

  2. Proximal outcome for exercise notifications. [ Time Frame: 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.

  3. All-cause mortality and Cardiovascular mortality [ Time Frame: 6-months ]
    The event numbers will be added together

  4. All-cause mortality and Cardiovascular mortality [ Time Frame: 12-months ]
    The event numbers will be added together

  5. Cardiovascular hospitalizations [ Time Frame: 6-months ]
  6. Cardiovascular hospitalizations [ Time Frame: 12-months ]
  7. Change in 6-minute walk distance [ Time Frame: 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.

  8. Change in 6-minute walk distance, subgroup analysis [ Time Frame: 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.

  9. Change in average step count, subgroup analysis [ Time Frame: 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.

  10. Subgroup analyses of micro-randomized notifications by notification type [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must be a patient within the Michigan Medicine clinical system with data available in the electronic health record after January 1, 2013
  • 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):

    1. Coronary artery disease (including acute coronary syndromes) following percutaneous coronary intervention (PCI)
    2. Coronary artery disease following coronary artery bypass surgery (CABG)]
    3. Valve repair or replacement (either surgical or percutaneous)

Exclusion Criteria:

  • Orthopedic or neurological condition limiting ability to actively engage in exercise training session
  • Greater than mild cognitive impairment
  • 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."
  • Currently receiving palliative care and/or in hospice care
  • Severe valvular stenosis or regurgitation
  • Unrevascularized left main coronary artery disease (> 50% obstruction on angiography) or proximal left anterior descending disease (>70% obstruction on angiography).
  • Exercise-induced ventricular tachycardia
  • Cardiac arrest within the prior 6 months
  • New York Heart Association (NYHA) class III or IV heart failure
  • Ejection fraction <40%
  • Determined to be unsafe for participation in cardiac rehabilitation as assessed by a clinical nurse.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04587882


Contacts
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Contact: Brahmajee Nallamothu, MD, MPH 734-647-1624 bnallamo@umich.edu

Locations
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United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Contact: Brahmajee Nallamothu, MD, Ph.D    734-647-1624    bnallamo@umich.edu   
Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: Brahmajee K Nallamothu University of Michigan
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Responsible Party: Brahmajee K Nallamothu, Professor of Internal Medicine, University of Michigan
ClinicalTrials.gov Identifier: NCT04587882    
Other Study ID Numbers: HUM00162365
First Posted: October 14, 2020    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Brahmajee K Nallamothu, University of Michigan:
Cardiac rehabilitation
Additional relevant MeSH terms:
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Cardiovascular Diseases
Heart Diseases