Heart FailureNCT05852509
Digital Health Physical Activity Program for Older Family Care Partners of Patents With Heart Failure
A study testing TPA4You in people with Heart Failure and Caregiver Burden, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure, Caregiver Burden
- What is being tested?
- TPA4You
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2024to 31 May 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Own a smartphone
- Reachable by telephone, text messaging, and email
- Have a 6x6ft space fit for physical activity in the place of residence
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- TPA4You, Attention control group
- Keywords
- heart failure, older adults, family caregivers, digital health, physical activity
- Medical subject headings
- Heart Failure, Caregiver Burden, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TPA4YouBehavioural
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 groupBehavioural
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 group | Role | What they receive |
|---|---|---|
| TPA4You group | Experimental | 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. Receives: Behavioral: TPA4You |
| Attention control group | Other | 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. Receives: Behavioral: Attention control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 6 months
Total sleep time
Total sleep time will be measured using the Fitbit Inspire 2 wearable wristband and collected from the Fitbit app.
Measured: 4 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.
Measured: 6 months
Sleep efficiency
Sleep efficiency will be measured using the Fitbit Inspire 2 wearable wristband and collected from the Fitbit app.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start1 Jul 2024
- Primary completion31 Mar 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Dawon Baik, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05852509
- Sponsor's protocol ID
- 21-4757
- Other IDs
- K23AG073471
- Status last verified
- Sep 2026
- First submitted
- 18 Apr 2023
- Last updated
- 2 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 41631240