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

Trial Summary

What is the purpose of this trial?

The proposed research will develop and test an online Emergency Preparedness Toolkit to help caregivers prepare for their own unexpected health events. Caregivers of persons with dementia often ignore their own health needs as their primary focus is the care of the person with dementia. This can lead to a caregiver delaying their own care and subsequently emergent health events. The Emergency Preparedness Toolkit provides guidance to the caregiver as to how to identify and transfer care to a standby caregiver. The goal is to provide a caregiver with the security and comfort that the person with dementia will be well cared for while they care for their own health needs.

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 data supports the effectiveness of the treatment Coaching Sessions for reducing caregiver burden?

Research shows that psychological and educational interventions can reduce caregiver distress, which may improve the quality of life for both caregivers and patients. Additionally, counseling and support interventions have been effective in delaying nursing home placement for patients with Alzheimer's, suggesting potential benefits for caregivers. ^{1 2 3 4 5}

Is it safe to participate in coaching sessions for caregiver burden?

The research articles reviewed do not provide specific safety data for coaching sessions for caregiver burden, but they focus on interventions like psychoeducational skill building and psychotherapy, which are generally considered safe for caregivers. ^{6 7 8 9 10}

How do coaching sessions for caregiver burden differ from other treatments for this condition?

Coaching sessions for caregiver burden are unique because they focus on providing personalized support and problem-solving strategies to caregivers, which can be delivered in a home setting. This approach is different from traditional treatments as it emphasizes direct interaction and practical guidance to help caregivers manage stress and improve their caregiving skills. ^{1 11 12 13 14}

Research Team

Rebecca S Boxer, MD, MS

Principal Investigator

University of California, Davis

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Sweden pubmed.ncbi.nlm.nih.gov

Can rehabilitation in the home setting reduce the burden of care for the next-of-kin of stroke victims? [2016]

2. United States pubmed.ncbi.nlm.nih.gov

Interventions to facilitate family caregiving at the end of life. [2022]

3. England 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. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Effect of a psycho-educational intervention for family members on caregiver burdens and psychiatric symptoms in patients with schizophrenia in Shiraz, Iran. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Improving caregiver well-being delays nursing home placement of patients with Alzheimer disease. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Empirically based treatments for family caregiver distress: what works and where do we go from here? [2019]

7. England pubmed.ncbi.nlm.nih.gov

Preserving health of Alzheimer caregivers: impact of a spouse caregiver intervention. [2007]

8. Germany pubmed.ncbi.nlm.nih.gov

Relatives' burden of caring for people screened positive for dementia in primary care : Results of the DelpHi study. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Translating the REACH OUT dementia caregiver intervention into a primary care setting: a pilot study. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Maintaining the potential of a psycho-educational program: efficacy of a booster session after an intervention offered family caregivers at disclosure of a relative's dementia diagnosis. [2015]

11. England pubmed.ncbi.nlm.nih.gov

Problem-solving in caregiver-counselling (PLiP Study): study protocol of a cluster randomized pragmatic trial. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

A dimensional analysis of caregiver burden among spouses and adult children. [2011]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Worry About Caregiving Performance: A Confirmatory Factor Analysis. [2020]

14. United States pubmed.ncbi.nlm.nih.gov

Moving beyond caregiver burden: identifying helpful interventions for family caregivers. [2015]