Digital Health Physical Activity Program for Older Family Care Partners of Patents With Heart Failure
Part of paid clinical trials in Aurora, Colorado.
- Sponsor
- University of Colorado, Denver
- Study ID
- NCT05852509
- Status
- Recruiting
Conditions
- Caregiver Burden
- Heart Failure
Eligibility Criteria
- Sex
- ALL
- Age
- 50 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- TPA4You — BEHAVIORALTPA4You integrates technology components in the form of video-conferencing (e.g., Zoom) with a health coach, wearable sensor (e.g., Fitbit), and personalized text messaging into a package to (a) tailor physical activity (PA) prescriptions based on the family care partners of persons with heart failure (HF-FCP)'s feedback and individual wearable sensor data, (b) provide tailored PA coaching sessions using video-conferencing, and (c) motivate daily exercise using text messages.
- Attention control group — BEHAVIORALParticipants will be given booklets, provided by the NIA, AHA, and National Alliance for Caregiving, that include content about self-care for FCPs' health and well-being, but not specific to PA or exercise. Participants will receive text messages every other day to encourage them to wear the Fitbit device, and to provide friendly greetings and reminders of upcoming survey data collection.
Study Details
The purpose of the Aim 3 study is to conduct a pilot randomized controlled trial to assess feasibility and preliminary effects of the TPA4You intervention.
Key Dates
- Start date
- Jul 1, 2024
- Status verified
- Jan 2026
- Primary completion
- Mar 31, 2027
- Completion
- May 31, 2027
Study Design
- Enrollment
- 32 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Experimental: TPA4You groupParticipants in the TPA4You group will be given an overview of the TPA4You program and PA exercise safety instructions. HF-FCPs will receive 28 PA sessions delivered by the coach over 12 weeks. The coached sessions will taper from 3 days/week (weeks 1-4) to 2 days/week (weeks 5-12) but exercise on 3 days/week will be recommended throughout. Participants will receive tailored motivational text messages every other day to encourage daily exercise and wearing the Fitbit.
- Other: Attention control groupParticipants will be given booklets, provided by the NIA, AHA, and National Alliance for Caregiving that include content about self-care for FCPs' health and well-being, but not specific to PA or exercise. Participants will receive text messages every other day to encourage them to wear the Fitbit device, and to provide friendly greetings and reminders of upcoming survey data collection.
Primary Outcome Measure
Daily physical activity counts [ Time Frame: 6 months ]
Central Contacts
- Dawon Baik, PhD3037241263
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Colorado | Aurora | Colorado | 80045 |
Find similar trials in Aurora, CO
By condition
By specialty
By research site
Related Studies
- Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy ProductsRecruiting · Medtronic · Birmingham, Alabama
- The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With FMRRecruiting · Cardiac Dimensions, Inc. · Gilbert, Arizona
- Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)Recruiting · Duke University · Phoenix, Arizona
- Goals of Care Conversations StudyEnrolling By Invitation · VA Office of Research and Development · Palo Alto, California