NCT05852509

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
12mo left

Started Jul 2024

Typical duration for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress64%
Jul 2024May 2027

First Submitted

Initial submission to the registry

April 18, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

May 10, 2023

Completed
1.1 years until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2027

Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

2.7 years

First QC Date

April 18, 2023

Last Update Submit

January 28, 2026

Conditions

Heart FailureCaregiver Burden

Keywords

heart failureolder adultsfamily caregiversdigital healthphysical activity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • Sedentary activity

    6 months

  • Physical function

    6 months

  • Depression

    6 months

  • Anxiety

    6 months

  • Stress

    6 months

  • +6 more secondary outcomes

Study Arms (2)

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.

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.

Behavioral: Attention control group

Interventions

TPA4YouBEHAVIORAL

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.

TPA4You group
Attention control groupBEHAVIORAL

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.

Attention control group

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado

Aurora, Colorado, 80045, United States

RECRUITING

Related Publications (1)

  • 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: 41631240DERIVED

MeSH Terms

Conditions

Heart FailureCaregiver BurdenMotor Activity

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesStress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Dawon Baik, PhD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dawon Baik, PhD

CONTACT

3037241263dawon.baik@cuanschutz.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2023

First Posted

May 10, 2023

Study Start

July 1, 2024

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

May 31, 2027

Last Updated

January 30, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)