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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05852509
• Other study ID #: 21-4757
• Secondary ID: K23AG073471
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: May 2023
• Source: University of Colorado, Denver
• Contact: Dawon Baik, PhD
• Phone: 3037241263
• Email: dawon.baik[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 62
• Est. completion date: December 31, 2026
• Est. primary completion date: August 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Caregiver Burden
• Heart Failure

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Institute on Aging (NIA)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 months
Secondary	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.	4 months
Secondary	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.	3 months
Secondary	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).	4 months
Secondary	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).	4 months
Secondary	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).	4 months
Secondary	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).	4 months
Secondary	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).	4 months
Secondary	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).	3 months
Secondary	Total sleep time	Total sleep time will be measured using the Fitbit Inspire 2 wearable wristband and collected from the Fitbit app.	4 months
Secondary	Wake after sleep onset	Wake after sleep onset will be measured using the Fitbit Inspire 2 wearable wristband and collected from the Fitbit app.	4 months
Secondary	Sleep efficiency	Sleep efficiency will be measured using the Fitbit Inspire 2 wearable wristband and collected from the Fitbit app.	4 months