Caregiver Support for Dementia

Overseen By https://redcap.link/PERSEVERE1

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rush University Medical Center

Disqualifiers: Severe depression, Suicidal ideation, Complicated grief, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

622 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on helping family caregivers of people with Lewy Body Dementia (LBD) by providing better tools and support. It aims to determine if mentoring from experienced caregivers can improve the knowledge, confidence, and well-being of those new to caregiving. Known as PERSEVERE: Peer Mentor Support and Caregiver Education in Lewy Body Dementia, the study will also examine how this support might affect the health and quality of life of the person with LBD. Individuals who have cared for a family member with LBD for less than three years and spend at least 10 hours a week on caregiving may be suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to valuable research that could enhance support systems for caregivers.

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 seems focused on caregiver support rather than medication changes.

What prior data suggests that the PERSEVERE program is safe for caregivers?

Research has shown that the PERSEVERE program, which provides support from experienced caregivers and education for those caring for someone with dementia, is safe for participants. A previous study found that this program was not only popular but also effective in enhancing caregivers' understanding and attitudes about dementia. No major safety issues or negative effects were reported.

In the program, experienced caregivers guide those with less experience through a course on caring for people with dementia. This approach emphasizes education and support rather than medical treatments or drugs, which generally reduces risks. Participants in earlier studies reported benefits without any major problems, indicating that the program is well-received. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Caregiver Support for Dementia trial because it introduces a new way to empower caregivers of individuals with Lewy Body Dementia (LBD) through a peer mentoring system. Unlike standard care, which typically involves professional assistance and support groups, this trial leverages the experience of veteran caregivers to mentor those new to the role, providing them with practical insights and emotional support. This peer-to-peer approach is unique as it taps into shared experiences, fostering a supportive community and potentially improving caregiver well-being and patient outcomes. Additionally, the use of the PERSEVERE curriculum, which is delivered digitally, offers accessible, structured learning tailored to the specific challenges presented by LBD, making it a flexible and comprehensive resource for caregivers.

What evidence suggests that PERSEVERE might be an effective support for LBD caregivers?

Research has shown that support from peer mentors and education for caregivers can greatly assist families caring for individuals with Lewy Body Dementia (LBD). In this trial, the program PERSEVERE connects less experienced caregivers, part of the Caregiver Mentees arm, with trained mentors from the Peer Mentors arm. Studies have found that peer mentoring is practical and beneficial for these caregivers, improving their understanding and attitudes about LBD. This support not only boosts caregivers' confidence but also reduces their stress. By enhancing caregivers' skills, PERSEVERE aims to improve the quality of life for both caregivers and those with LBD, potentially lowering the need for emergency healthcare visits. ^{1 2 3 6 7}

Who Is on the Research Team?

Jori E Fleisher, MD MSCE

Principal Investigator

Rush University Medical Center

Are You a Good Fit for This Trial?

This trial is for family caregivers of individuals with Lewy Body Dementia (LBD), which includes those caring for persons with Parkinson's Disease and dementia. Caregivers who want to improve their knowledge, skills, and confidence in managing LBD challenges are eligible. Specific inclusion and exclusion criteria details were not provided.

Inclusion Criteria

Caregivers must meet the same criteria as Peer Mentors

Peer Mentors must not have any known terminal diagnoses or life expectancy less than 2 years by self-report

I can understand and agree to participate in research.

Exclusion Criteria

Peer Mentors must not have been paid for more than 50% of their caregiving responsibilities

Peer Mentors must not have PHQ-9 greater than 14, PHQ-9 question 9 greater than 1, or BGQ greater than 5

Peer Mentors must not endorse a known terminal diagnosis or life expectancy less than 2 years by self-report

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the PERSEVERE intervention, which includes peer mentor support and caregiver education, for 12 weeks.

12 weeks

Weekly phone or videoconference calls

Follow-up

Participants are monitored for caregiver strain and PLBD outcomes, including healthcare utilization, for six months after the intervention.

6 months

Biweekly online surveys

What Are the Treatments Tested in This Trial?

Interventions

• PERSEVERE

Trial Overview

The PERSEVERE trial tests a program where caregivers are paired with trained peer mentors versus receiving weekly educational materials. The goal is to see if this support improves caregiver mastery, reduces strain, enhances patient quality of life, and decreases healthcare use over a 12-week period.

How Is the Trial Designed?

Group I: Peer mentors Experimental Treatment 1 Intervention

Experienced LBD caregivers with \>3 years' caregiving experience OR caregivers whose loved one with LBD is deceased will be recruited and trained through asynchronous and synchronous online peer mentor training to serve as mentors to less experienced LBD caregivers in the experimental arm.

Group II: Caregiver Mentees Experimental Treatment 1 Intervention

Less experienced LBD family caregivers (\<3 years since care recipient's cognitive impairment and/or hallucinations began) will receive PDF and website versions of the PERSEVERE modular curriculum, covering key areas of knowledge in LBD symptom and progression, caregiver strain and self-care, and links to pre-existing additional resources available on the web through various patient-facing foundations (e.g., Lewy Body Dementia Association, Parkinson's Foundation). These mentees will be matched with a trained peer mentor and will complete weekly phone or videoconference calls with each other, using the PDF and/or web-based curriculum (identical in content) as a guide for practical discussions for 12 weeks. They will complete biweekly online surveys regarding frequency, duration, and content of mentoring calls, and any falls or acute healthcare utilization of their care recipient. After the 12 weeks of mentoring, they will complete biweekly surveys for six months of follow-up.

Group III: Education Group Active Control 1 Intervention

Less experienced LBD family caregivers (\<3 years since care recipient's cognitive impairment and/or hallucinations began) randomized (1:1) to the education group arm will receive weekly emails from the study team delineating key topics in LBD symptom and progression, caregiver strain and self-care, and links to pre-existing additional resources available on the web through various patient-facing foundations (e.g., Lewy Body Dementia Association, Parkinson's Foundation). They will complete biweekly online surveys regarding frequency, duration, and content of mentoring calls, and any falls or acute healthcare utilization of their care recipient. After the 12 weeks of emails, they will complete biweekly surveys for six months of follow-up.

PERSEVERE is already approved in United States for the following indications:

Approved in United States as PERSEVERE for:

• Support and education for caregivers of individuals with Lewy Body Dementia

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials

448

Recruited

247,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

A survey of 962 caregivers of individuals with Lewy body dementia revealed that 80% felt misunderstood in their burden, with many experiencing moderate-to-severe stress and isolation, particularly spousal caregivers.

Despite significant challenges, including medical crises, only 29% of caregivers sought in-home assistance, indicating a need for better access to resources and support services for LBD caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lewy body dementia: caregiver burden and unmet needs. Galvin, JE., Duda, JE., Kaufer, DI., et al.[2023]

A peer mentor-led educational intervention for family caregivers of individuals with Lewy Body Disease (LBD) was found to be feasible and well-received, with 95.3% of calls rated as useful by participants.

The intervention significantly improved caregivers' knowledge about LBD by 13% and their attitudes towards dementia by 7%, demonstrating its effectiveness in supporting caregivers in managing their roles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Learning to PERSEVERE: A pilot study of peer mentor support and caregiver education in Lewy body dementia. Fleisher, JE., Suresh, M., Levin, ME., et al.[2023]

Family carers of individuals with Lewy body dementia experience a high burden due to the rapid decline and complex symptoms associated with the condition, highlighting the need for targeted support services.

The adapted STrAtegies for RelaTives (START) therapy was found to be acceptable and feasible for LBD carers, suggesting it could provide valuable support and coping strategies, warranting further trials to assess its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of START (STrAtegies for RelaTives) adapted for carers of people with Lewy body dementia. Foley, JA., Dore, C., Zarkali, A., et al.[2023]

Patients diagnosed with dementia with Lewy bodies (DLB) have a significantly shorter average survival time of 4.11 years compared to 5.66 years for those with Alzheimer's disease (AD), indicating a difference of 1.60 years (p < 0.01).

The relative risk of death for individuals with DLB is 1.35 times higher than for those with AD (p < 0.01), highlighting the need for increased research and awareness regarding the prognosis of DLB.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survival time and differences between dementia with Lewy bodies and Alzheimer's disease following diagnosis: A meta-analysis of longitudinal studies. Mueller, C., Soysal, P., Rongve, A., et al.[2021]

Caregivers of individuals with dementia with Lewy bodies (DLB) experience significantly higher levels of distress compared to caregivers of those with Alzheimer's disease (AD), with 40% of DLB caregivers reporting moderate to high burden versus 20.2% for AD caregivers.

The study found that caregiver distress is closely linked to the neuropsychiatric symptoms of the person receiving care and their ability to perform daily activities, highlighting the need for tailored support resources for caregivers of DLB patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Caregiver burden in family carers of people with dementia with Lewy bodies and Alzheimer's disease. Svendsboe, E., Terum, T., Testad, I., et al.[2022]

A group-based intervention for individuals with dementia with Lewy bodies (DLB) and their family care partners was found to be feasible and acceptable, with 19 dyads participating and minimal attrition during the four-week program.

Participants reported feeling more in control and better able to cope in multiple areas, suggesting that such interventions can enhance understanding of DLB and reduce social isolation, particularly for those with less prior knowledge and higher stress levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The feasibility and acceptability of a psychosocial intervention to support people with dementia with Lewy bodies and family care partners. Killen, A., Flynn, D., O'Brien, N., et al.[2022]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37385161/

A pilot study of peer mentor support and caregiver education ...

Objective: We assessed feasibility of a peer mentor-led educational intervention and its impact on LBD family caregivers' knowledge, dementia ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06389032

PERSEVERE: Peer Mentor Support and Caregiver ...

Results will illuminate the extent to which leveraging prior LBD caregivers as expert interventionists can improve current caregiver outcomes, and in turn, PLBD ...

3.

lbda.org

lbda.org/peer-mentoring-support-and-caregiver-education-persevere/

Peer Mentoring Support and Caregiver Education ...

This study is testing an educational program for family care partners of people with Parkinson's disease dementia (PDD) or dementia with Lewy bodies (DLB).

4.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1353802023002158

A pilot study of peer mentor support and caregiver ...

Lewy Body Dementia (LBD) family caregivers are grossly underrepresented in research. · Peer mentoring is feasible, satisfactory, and effective for LBD caregivers ...

5.

neurology.org

neurology.org/doi/10.1212/WNL.98.18_supplement.1747

Learning to PERSEVERE: Feasibility and Efficacy of Peer ...

A novel LBD family caregiver peer mentoring program was clearly feasible and well received. Mentors and mentees improved their LBD knowledge and attitudes.

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04649164

Learning to PERSEVERE: Peer Mentor Support and ...

Studies cite a crucial need for education and support of LBD caregivers, who face high rates of caregiver strain and adverse outcomes. Evidence from other ...

7.

neurology.org

neurology.org/doi/abs/10.1212/WNL.0000000000211276

PERSEVERE: National Randomized Controlled Trial of ...

A national virtual randomized controlled trial of a 12-week peer mentor-supported intervention on family caregiver knowledge, attitudes, and strain.