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

Primary Purpose

Heart Failure, Caregiver Burden

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
TPA4You
Attention control group
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Heart Failure focused on measuring heart failure, older adults, family caregivers, digital health, physical activity

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    TPA4You group

    Attention control group

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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.
    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).
    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).
    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).
    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).
    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).
    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).
    Total sleep time
    Total sleep time will be measured using the Fitbit Inspire 2 wearable wristband and collected from the Fitbit app.
    Wake after sleep onset
    Wake after sleep onset will be measured using the Fitbit Inspire 2 wearable wristband and collected from the Fitbit app.
    Sleep efficiency
    Sleep efficiency will be measured using the Fitbit Inspire 2 wearable wristband and collected from the Fitbit app.

    Full Information

    First Posted
    April 18, 2023
    Last Updated
    May 15, 2023
    Sponsor
    University of Colorado, Denver
    Collaborators
    National Institute on Aging (NIA)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05852509
    Brief Title
    Digital Health Physical Activity Program for Older Family Care Partners of Patents With Heart Failure
    Official Title
    Digital Health Physical Activity Program for Older Family Care Partners of Patents With Heart Failure
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 1, 2024 (Anticipated)
    Primary Completion Date
    August 31, 2026 (Anticipated)
    Study Completion Date
    December 31, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Colorado, Denver
    Collaborators
    National Institute on Aging (NIA)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart Failure, Caregiver Burden
    Keywords
    heart failure, older adults, family caregivers, digital health, physical activity

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    62 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    TPA4You group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Attention control group
    Arm Type
    Other
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    TPA4You
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Attention control group
    Intervention Description
    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 Outcome Measure Information:
    Title
    Daily physical activity counts
    Description
    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.
    Time Frame
    4 months
    Secondary Outcome Measure Information:
    Title
    Sedentary activity
    Description
    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.
    Time Frame
    4 months
    Title
    Physical function
    Description
    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.
    Time Frame
    3 months
    Title
    Depression
    Description
    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).
    Time Frame
    4 months
    Title
    Anxiety
    Description
    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).
    Time Frame
    4 months
    Title
    Stress
    Description
    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).
    Time Frame
    4 months
    Title
    Caregiving self-efficacy
    Description
    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).
    Time Frame
    4 months
    Title
    Health related quality of life
    Description
    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).
    Time Frame
    4 months
    Title
    Usability of TPA4You
    Description
    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).
    Time Frame
    3 months
    Title
    Total sleep time
    Description
    Total sleep time will be measured using the Fitbit Inspire 2 wearable wristband and collected from the Fitbit app.
    Time Frame
    4 months
    Title
    Wake after sleep onset
    Description
    Wake after sleep onset will be measured using the Fitbit Inspire 2 wearable wristband and collected from the Fitbit app.
    Time Frame
    4 months
    Title
    Sleep efficiency
    Description
    Sleep efficiency will be measured using the Fitbit Inspire 2 wearable wristband and collected from the Fitbit app.
    Time Frame
    4 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dawon Baik, PhD
    Phone
    3037241263
    Email
    dawon.baik@cuanschutz.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Dawon Baik, PhD
    Organizational Affiliation
    University of Colorado, Denver
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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