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

Not Applicable

Not yet recruiting

• Conditions: Heart Failure; Caregiver Burden
• Interventions: Behavioral: Attention control group; Behavioral: TPA4You

• Registration Number: NCT05852509
• Lead Sponsor: University of Colorado, Denver

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-18
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-01
• Study First Posted: 2023-05-10
• Last Update Submitted: 2023-05-15
• Last Update Posted: 2023-05-17
• Study Start: 2024-06-01
• Primary Completion: 2026-08-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

• Age greater than or equal to 60 years
• Involved in caring for a household member aged 60 years or older with the New York Heart Association Class II, III or IV HF
• Provide at least 10 hours/week of unpaid care for the past 6 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 over the past 6 months
• Able to read, speak, and comprehend 5th grade English
• Own a smartphone
• Reachable by telephone, text messaging, and email

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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]52 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Attention control group	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.
TPA4You group	TPA4You	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.

Primary Outcome Measures

Name	Time	Method
Daily physical activity counts	4 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 Outcome Measures

Name	Time	Method
Caregiving self-efficacy	4 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).
Physical function	3 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.
Anxiety	4 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).
Total sleep time	4 months	Total sleep time will be measured using the Fitbit Inspire 2 wearable wristband and collected from the Fitbit app.
Wake after sleep onset	4 months	Wake after sleep onset will be measured using the Fitbit Inspire 2 wearable wristband and collected from the Fitbit app.
Stress	4 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).
Sedentary activity	4 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.
Usability of TPA4You	3 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).
Depression	4 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).
Health related quality of life	4 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).
Sleep efficiency	4 months	Sleep efficiency will be measured using the Fitbit Inspire 2 wearable wristband and collected from the Fitbit app.