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NCT Number: NCT05852509

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.

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Key information

Conditions

Heart Failure Behavior Behavioral Symptoms Cardiovascular Diseases Caregiver Burden Heart Diseases Motor Activity Stress, Psychological

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado

Aurora, Colorado, 80045, United States

Location status: Recruiting

Location contact

Assistant Professor

CONTACT

[email protected]

303-724-1812

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

TPA4You

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

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.

Primary outcomes

  1. Daily physical activity counts

    Time frame: 6 months

    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.

Secondary outcomes

  1. Sedentary activity

    Time frame: 6 months

    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.

  2. Physical function

    Time frame: 6 months

    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.

  3. Depression

    Time frame: 6 months

    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).

  4. Anxiety

    Time frame: 6 months

    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).

  5. Stress

    Time frame: 6 months

    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. Caregiving self-efficacy

    Time frame: 6 months

    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).

  7. Health related quality of life

    Time frame: 6 months

    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).

  8. Usability of TPA4You

    Time frame: 6 months

    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).

  9. Total sleep time

    Time frame: 4 months

    Total sleep time will be measured using the Fitbit Inspire 2 wearable wristband and collected from the Fitbit app.

  10. Wake after sleep onset

    Time frame: 6 months

    Wake after sleep onset will be measured using the Fitbit Inspire 2 wearable wristband and collected from the Fitbit app.

  11. Sleep efficiency

    Time frame: 6 months

    Sleep efficiency will be measured using the Fitbit Inspire 2 wearable wristband and collected from the Fitbit app.

Study contacts

Contact information is provided by the study sponsor or research team.

Dawon Baik, PhD

CONTACT

[email protected]

3037241263

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
May 10, 2023
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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