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

Sponsor

University of Colorado, Denver (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05852509

Collaborator

National Institute on Aging (NIA) (NIH)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure Caregiver Burden	Behavioral: TPA4You Behavioral: Attention control group	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

62 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2024

Anticipated Primary Completion Date :

Aug 31, 2026

Anticipated Study Completion Date :

Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TPA4You group 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 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.
Other: 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.	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.

Arm

Intervention/Treatment

Experimental: TPA4You group

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

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.

Other: 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.

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.

Outcome Measures

Primary Outcome Measures

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

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.
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.
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).
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).
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).
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).
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).
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).
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.
Sleep efficiency [4 months]
Sleep efficiency will be measured using the Fitbit Inspire 2 wearable wristband and collected from the Fitbit app.

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

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