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

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure; Caregiver Burden
• Intervention / Treatment: Behavioral: TPA4You; Behavioral: Attention control group

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dawon Baik, PhD; Phone Number: 3037241263; Email: dawon.baik@cuanschutz.edu

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado
      • Contact: Assistant Professor; Phone Number: 303-724-1812; Email: dawon.baik@cuanschutz.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: 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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daily physical activity counts	Daily physical activity counts will be measured using the Fitbit Inspire 2 wearable wristband which is an accelerometer-based activity tracker. Total PA counts will be downloaded from the Fitbit app.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total sleep time	Total sleep time will be measured using the Fitbit Inspire 2 wearable wristband and collected from the Fitbit app.	4 months
Sedentary activity	Sedentary activity will be measured using the Fitbit Inspire 2 wearable wristband which is an accelerometer-based activity tracker. The data will be downloaded from the Fitbit app. Sedentary activity is defined as less than 100 counts/min.	6 months
Physical function	30-Second Chair Stand Test will be used to assess lower-body strength. The coach will explain the test to participants and measure performance. Participants will sit squarely in a stable chair with arms crossed over chest, and, with a straight back rise to a full standing position without use of hands, return to the seated position and repeat for 30 seconds.	6 months
Depression	Depression will be measured using the Center for Epidemiological Studies Depression Scale (CES-D), a 20-item questionnaire rated on a 4-point Likert scale ranging from 0 to 3 (higher scores = worse depressive symptom).	6 months
Anxiety	Anxiety will be measured using the State Trait Anxiety Index, a 20-item questionnaire rated on a 4-point scale with total scores from 1 to 80 (higher scores = worse anxiety symptom).	6 months
Stress	Stress will be measured using the Perceived Stress Scale (PSS), a 10-item questionnaire rated on a 5-point Likert scale ranging from 0 to 4 (higher scores = worse stress).	6 months
Caregiving self-efficacy	Caregiving self-efficacy will be measured using the Revised Scale for Caregiving Self-Efficacy (RSCSE), a 15-item questionnaire rated on an 11-point scale ranging from 0 to 100 (higher scores = better self-efficacy).	6 months
Health related quality of life	Health related quality of life (HRQoL) will be measured using the Short Form 36 version 2,a 36-item questionnaire with 2 domains (physical and psychological health) (higher scores = better HRQoL).	6 months
Usability of TPA4You	Self-reported ease of use and usability of TPA4You will be measured with the refined 20-item Health Information Technology (IT) Usability Evaluation Scale (Health-ITUES) (higher scores = better usability).	6 months
Wake after sleep onset	Wake after sleep onset will be measured using the Fitbit Inspire 2 wearable wristband and collected from the Fitbit app.	6 months
Sleep efficiency	Sleep efficiency will be measured using the Fitbit Inspire 2 wearable wristband and collected from the Fitbit app.	6 months

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Dawon Baik, PhD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: April 18, 2023
• First Submitted That Met QC Criteria: May 1, 2023
• First Posted (Actual): May 10, 2023

Study Record Updates

• Last Update Posted (Actual): January 30, 2026
• Last Update Submitted That Met QC Criteria: January 28, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: physical activity; older adults; heart failure; digital health; family caregivers
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Behavioral Symptoms; Stress, Psychological; Behavior; Caregiver Burden; Heart Failure; Motor Activity
• Other Study ID Numbers: 21-4757; K23AG073471 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No