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Recruiting NCT05852509

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

No phase Interventional Heart Failure Caregiver Burden

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TPA4You, Attention control group.
Who it may be relevant to
Registry conditions: Heart Failure, Caregiver Burden. Basic parameters: from 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • Daily physical activity counts [Time frame: 6 months]
Secondary outcome measures (11)
  • Sedentary activity [Time frame: 6 months]
  • Physical function [Time frame: 6 months]
  • Depression [Time frame: 6 months]
  • Anxiety [Time frame: 6 months]
  • Stress [Time frame: 6 months]
  • Caregiving self-efficacy [Time frame: 6 months]
  • Health related quality of life [Time frame: 6 months]
  • Usability of TPA4You [Time frame: 6 months]
  • Total sleep time [Time frame: 4 months]
  • Wake after sleep onset [Time frame: 6 months]
  • Sleep efficiency [Time frame: 6 months]

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.)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • University of Colorado — Aurora

Publications

  • Baik D, Coats H, Reeder B, Allen LA, Jankowski C. Digital health physical activity coaching for older family caregivers of persons with heart failure - TPA4You: Protocol for a pilot randomized controlled trial. Contemp Clin Trials Commun. 2026 Jan 20;49:101604. doi: 10.1016/j.conctc.2026.101604. eCollection 2026 Feb. PMID 41631240

Identifiers

NCT: NCT05852509 · 21-4757 · K23AG073471

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗