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

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • TPA4You — BEHAVIORAL
    TPA4You 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 — BEHAVIORAL
    Participants 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 group
    Participants 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 group
    Participants 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

Locations (1)

FacilityCityStateZIPSite coordinators
University of ColoradoAuroraColorado80045
Assistant Professor
303-724-1812

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