Coaching Sessions for Caregiver Burden

Overseen By Rebecca S Boxer, MD, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Davis

Disqualifiers: Dementia, Computer access, Deafness, others

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

Compensation: Varies

Number of Visits: 2

68 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist caregivers of people with dementia in planning for unexpected health events by testing an online tool called the Emergency Preparedness Toolkit. The toolkit guides caregivers in transferring care responsibilities to a backup caregiver, ensuring continued care for the person with dementia. Participants will either receive coaching sessions (supportive guidance) to help complete the toolkit or be asked to complete it independently. This trial suits those who live with and provide some care for a spouse or partner with dementia. As an unphased trial, it offers caregivers a unique opportunity to enhance their preparedness and effectively support their loved ones.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems unlikely, as the study focuses on caregiver support rather than medical treatment.

What prior data suggests that these coaching sessions are safe for caregivers?

Research has shown that coaching sessions can be safe and helpful for caregivers. For example, one study found that online health coaching helped caregivers of people with heart failure take better care of themselves and feel less stressed. Another study showed that a remote monitoring and coaching program reduced caregiver stress by 38% in just eight weeks. As a result, caregivers felt less stressed and overwhelmed. These findings suggest that coaching sessions are well-received and can help caregivers manage their duties without adding extra stress. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the potential benefits of coaching sessions in reducing caregiver burden, something traditional treatment options like support groups or counseling don't specifically address. The unique aspect of these coaching sessions is their focus on helping caregivers complete an effective personal training program (EPT), offering a more structured approach compared to self-managed methods. By providing targeted support, the coaching sessions could offer caregivers practical tools to manage stress and improve their overall well-being, which might be a significant improvement over existing strategies.

What evidence suggests that coaching sessions are effective for reducing caregiver burden?

Research has shown that coaching sessions can reduce stress and burden on caregivers. In this trial, participants in the EPT-C group will receive two coaching sessions to assist with completing the EPT. Digital tools, such as online coaching, can offer short-term benefits. Stress management programs have also been shown to lower caregivers' stress levels. Educational programs can enhance caregivers' perceptions of their responsibilities. These findings suggest that coaching sessions might offer valuable support, helping caregivers manage stress and feel more in control. ^{2 3 6 7 8}

Who Is on the Research Team?

Rebecca S Boxer, MD, MS

Principal Investigator

University of California, Davis

Are You a Good Fit for This Trial?

This trial is for spouses or partners over 18 who live with and care for someone with dementia. They must recognize their role as caregivers and be willing to prepare for their own health emergencies using an online toolkit.

Inclusion Criteria

I am the spouse or partner of a person with dementia.

I provide care to someone with a disability.

I live with the person with dementia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants use the Emergency Preparedness Toolkit (EPT) with or without coaching sessions

6 weeks

2 coaching sessions for EPT-C group

Follow-up

Participants are monitored for changes in caregiver confidence, self-efficacy, and preparedness

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Coaching Sessions

Trial Overview The study tests an Emergency Preparedness Toolkit designed to help caregivers of dementia patients plan for unexpected personal health crises, ensuring the person they care for will have a standby caregiver ready.

How Is the Trial Designed?

Group I: EPT-C Active Control 1 Intervention

The EPT-C group will receive two coaching sessions to assist with the completion of the EPT.

Group II: EPT-A Active Control 1 Intervention

The EPT-A group will be responsible for completing the EPT alone, without coaching sessions.

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

The caregiver stress management intervention, PsychoEducation, Paced Respiration, and Relaxation (PEPRR), significantly reduced caregiver distress over 3 months, indicating its efficacy in supporting caregivers of patients undergoing allogeneic hematopoietic stem cell transplant.

Despite the reduction in caregiver distress, the intervention did not lead to a significant improvement in patient quality of life as measured by the FACT-BMT scale, suggesting that the scale may not capture the psychological benefits of caregiver support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized control trial of stress management for caregivers of stem cell transplant patients: Effect on patient quality of life and caregiver distress. Laudenslager, ML., Simoneau, TL., Mikulich-Gilbertson, SK., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11244754/

Health Coaching Improves Outcomes of Informal ... A systematic review of interventions for HF caregivers showed limited effectiveness. With only half impacting caregiver burden and well-being, alternative ...

2. frontiersin.org frontiersin.org/journals/digital-health/articles/10.3389/fdgth.2025.1636084/pdf

based interventions for reducing caregiver burden and stress Conclusion: Digital technology-based interventions demonstrate moderate effectiveness in reducing caregiver burden and stress in the short term.

3. bmcnephrol.biomedcentral.com bmcnephrol.biomedcentral.com/articles/10.1186/s12882-024-03795-5

Stress management training program to address caregiver ... Additionally, a decrease in the average caregiver burden score compared to before the intervention was observed in both groups; yet, notably, ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1471595321003152

Effectiveness of an educational intervention to reduce the ... In this sense, studies carried out in family caregivers have shown how an educational intervention improves the caregiver burden (Aksoydan et al., 2019; ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8205323/

Caregiver Burden - PubMed Central - NIH Caregiver burden can lead to exhaustion, loss of control, stress, chronic disease, loss of self-identity, withdrawal from family and friends, ...

6. cdc.gov cdc.gov/mmwr/volumes/73/wr/mm7334a2.htm

Changes in Health Indicators Among Caregivers The time commitment and responsibilities of caregiving can place an undue emotional, economic, and physical burden on caregivers (2). During ...

7. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/full/10.1002/cncr.35131

Impact of an automated, remote monitoring and coaching ... The SCH intervention reduced overall Caregiver Burden compared to UC (p < .001), with a 38% reduction at 8 weeks and a medium-to-large effect ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0197457225003568

Impact of a community-based educational intervention on ... The results reveal a notable reduction in caregiver burden, with ZBI scores decreasing from 47.14 to 39.55 (p = 0.003). This reduction suggests that caregivers ...