Digital Health Physical Activity Program for Older Family Care Partners of Patents With Heart Failure

NCT ID: NCT05852509

Last Updated: 2026-01-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2027-05-31

Brief Summary

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.

Conditions

Heart Failure; Caregiver Burden

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

TPA4You

Intervention Type: 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

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.

Group Type: OTHER

Attention control group

Intervention Type: 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.

Interventions

TPA4You

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Eligibility 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.)

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dawon Baik, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado

Aurora, Colorado, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Dawon Baik, PhD

Role: CONTACT

dawon.baik@cuanschutz.edu

3037241263

Facility Contacts

Assistant Professor

Role: primary

dawon.baik@cuanschutz.edu

303-724-1812

Other Identifiers

K23AG073471

Identifier Type: NIH

Identifier Source: secondary_id

View Link

21-4757

Identifier Type: -

Identifier Source: org_study_id