Digital Health Program for Caregiver Burden

Overseen By Dawon Baik, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Cognitive impairment, Unstable cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

62 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called TPA4You, designed to improve caregivers' well-being through guided physical activity. The researchers aim to determine if this program is practical and beneficial by comparing its effects to standard self-care advice. Participants will either follow TPA4You, which includes exercise sessions and motivational texts, or receive general health booklets and reminders. The trial seeks caregivers who spend at least 8 hours a week caring for someone with heart failure and currently engage in less than 90 minutes of moderate exercise weekly. As an unphased trial, it offers caregivers the opportunity to enhance their well-being through innovative support.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the TPA4You intervention is safe?

Research shows that the TPA4You program is generally easy to use. This digital health program, designed for caregivers, focuses on physical activity and offers personalized support through technology. Although specific details on side effects are unavailable, similar technology-based health programs have been manageable for users. Participants in earlier studies used the program without major problems, and it aims to reduce caregiver stress and improve health. So far, no serious side effects have been reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the TPA4You program because it offers a digital health approach specifically tailored for caregivers dealing with high stress and physical demands. Unlike traditional self-care booklets and general advice, TPA4You combines personalized physical activity sessions with motivational text messages, making it an interactive and engaging experience. The use of a coach to guide 28 exercise sessions over 12 weeks, along with the integration of wearable tech like Fitbits, provides continuous support and monitoring, which is not commonly available in existing caregiver support programs. This innovative method aims to significantly reduce caregiver burden by promoting regular exercise and offering consistent motivation.

What evidence suggests that the TPA4You intervention could be effective for reducing caregiver burden?

Research shows that digital tools can help reduce stress and burden on caregivers, at least temporarily. In this trial, participants in the TPA4You group, a digital health program focused on physical activity, will receive exercise sessions and motivational text messages to encourage activity. This program targets older family caregivers, especially those caring for individuals with heart failure. Meanwhile, participants in the attention control group will receive booklets on self-care and friendly text messages. Caregivers who have tried similar programs have reported positive experiences, suggesting these programs might enhance their well-being. While the specific effects of TPA4You are still under study, similar digital programs have effectively supported caregivers. ^{4 6 7 8 9}

Who Is on the Research Team?

Dawon Baik, PhD

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

This trial is for individuals aged 60 or older who are caring for a family member with Class II, III, or IV heart failure. They must provide at least 10 hours of unpaid care weekly, be physically able to exercise, not currently active (less than 30 minutes of moderate exercise less than three times a week), and have basic English literacy and access to a smartphone.

Inclusion Criteria

I have been providing unpaid care for at least 10 hours a week for the past 6 months.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in the TPA4You group receive 28 PA sessions over 12 weeks, with sessions tapering from 3 days/week to 2 days/week, and receive motivational text messages.

12 weeks

Sessions with coach, text messages every other day

Follow-up

Participants are monitored for safety and effectiveness after treatment, including measures of sleep, physical activity, and psychological health.

4 months

What Are the Treatments Tested in This Trial?

Interventions

• Attention control group
• TPA4You

Trial Overview The study is testing the 'TPA4You' digital health program designed to increase physical activity among older caregivers. Participants will either receive this intervention or be placed in an attention control group. The aim is to see if TPA4You is feasible and effective in improving motor skills and reducing caregiver burden.

How Is the Trial Designed?

Group I: TPA4You group Experimental Treatment 1 Intervention

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.

Group II: Attention control group Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0197457225005208

Engagement in a digital health physical activity program ... This study examined the perceptions of older family care partners of persons with heart failure (HF-FCPs) about a tailored digital physical activity program ...

2. news.cuanschutz.edu news.cuanschutz.edu/dbmi/nursing-informatics

Advancing Nursing Informatics Education and Innovation Baik is also leading the development of the TPA4You digital health physical activity program for older family caregivers of individuals with ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10201006/

Digital health interventions to support family caregivers This article aims to provide an updated review of interventions using digital health tools to support family caregivers and the scope of the Human-Centered ...

4. academic.oup.com academic.oup.com/innovateage/article-pdf/7/Supplement_1/782/54745181/igad104.2528.pdf

782 13/15 were spouses. The perceived value of TPA4You ... This study aims to identify intensity of caregiving experience profiles and compare the profiles to multidimensional physical health indicators and health be-.

5. frontiersin.org frontiersin.org/journals/digital-health/articles/10.3389/fdgth.2025.1636084/full

Efficacy of Digital Technology-Based Interventions for ... Conclusion: Digital technology-based interventions demonstrate moderate effectiveness in reducing caregiver burden and stress in the short term. However ...

6. withpower.com withpower.com/trial/phase-heart-failure-5-2024-884f6

Digital Health Program for Caregiver Burden ... TPA4You will have tolerable side effects & efficacy for patients with Caregiver Burden, Heart Failure, Motor Skills, Heart Failure and Caregiver Burden. See

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41129906/

Engagement in a digital health physical activity program ... The findings underscore the importance of technology-supported health strategies tailored to caregiving burden, age-related health ...

8. ctv.veeva.com ctv.veeva.com/study/digital-health-physical-activity-program-for-older-family-care-partners-of-patents-with-heart-failur

Digital Health Physical Activity Program for Older Family Care ... Caregiver Burden. Heart Failure. Treatments. Behavioral: Attention control ... Participants in the TPA4You group will be given an overview of the TPA4You program ...

9. researchgate.net researchgate.net/profile/Dawon-Baik

Dawon BAIK | University of Colorado, Denver | UCD Caregiving for older adults with chronic disease places a considerable burden on FCGs and they tend to neglect their personal health. Generally, physical ...