Digital physical activity program for older family caregivers of people with heart failure
Digital Health Physical Activity Program for Older Family Care Partners of Patents With Heart Failure
This pilot will test whether a smartphone-delivered program (TPA4You) can help older family caregivers of people with heart failure become more physically active compared with an attention control.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT05852509 on ClinicalTrials.gov |
What this trial studies
This is a pilot randomized controlled trial that will randomize older family caregivers to the TPA4You digital physical activity program or an attention control group to measure feasibility and preliminary effects. Eligible participants are caregivers aged 50 or older who provide regular unpaid care to a household member with NYHA class II–IV heart failure, are underactive, and are physically able to perform home-based exercise. The intervention is delivered via smartphone and designed for use in the participant's residence with brief structured walking and upper-body resistance activities. Outcomes will focus on feasibility metrics and early signals of change in physical activity and caregiver-related health measures.
Who should consider this trial
Good fit: Ideal candidates are unpaid family caregivers aged 50 or older who spend at least 8 hours per week caring for a household member (also ≥50) with NYHA class II–IV heart failure, are currently underactive, physically able to exercise at home, and own a smartphone.
Not a fit: Patients with medical or functional limitations that prevent safe participation in walking or resistance exercises, those with significant cognitive impairment, or those already meeting recommended activity levels are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the program could help caregivers increase regular physical activity and improve their health and caregiving capacity.
How similar studies have performed: Related digital and home-based physical activity programs have produced modest improvements in activity and wellbeing in older adults, but caregiver-targeted digital PA interventions are limited, so this pilot represents a relatively novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Age greater than or equal to 50 years
* Involved in caring for a household member aged 50 years or older with the New York Heart Association Class II, III or IV HF
* Provide at least 8 hours/week of unpaid care for the past 3 months
* Physically able to engage in structured exercise such as walking, and upper body resistance exercises
* Engage in \< 30 min of moderate-intensity exercise on fewer than 3 days per week
* Able to read, speak, and comprehend 5th grade English
* Own a smartphone
* Reachable by telephone, text messaging, and email
* Have a 6x6ft space fit for physical activity in the place of residence
Exclusion Criteria:
* Medical or functional conditions precluding participation in the physical activity (PA) components of the intervention (e.g., inability to walk one block or climb stairs without chest pain, shortness of breath, dizziness; history of falls; or serious or unstable cardiovascular or pulmonary disease)
* Cognitive impairment (Telephone Interview for Cognitive Status \[TICS\] score \< 25)
* Inability to use technology
* Participation in a PA intervention in the previous 6 months
* Current participation in a PA or behavior change trial
* Physical activity unpreparedness ('Yes' to any questions 1-4 the Physical Activity Readiness Questionnaire \[PAR-Q\]. If participants respond 'yes' to any questions 5-7, we will ask follow-up questions.)
Where this trial is running
Aurora, Colorado
- University of Colorado — Aurora, Colorado, United States (Recruiting)
Study contacts
- Principal investigator: Dawon Baik, PhD — University of Colorado, Denver
- Study coordinator: Dawon Baik, PhD
- Email: dawon.baik@cuanschutz.edu
- Phone: 3037241263
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.