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

Trial Summary

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 data supports the effectiveness of the treatment PERSEVERE for caregivers of people with Lewy Body Dementia?

The PERSEVERE treatment is based on a successful peer mentoring program used in advanced Parkinson's Disease, suggesting it may help caregivers of people with Lewy Body Dementia by providing education and support. Additionally, similar programs like START have shown to reduce depression and anxiety in dementia caregivers, indicating potential benefits for those caring for individuals with Lewy Body Dementia. ^{1 2 3 4 5}

Is the Caregiver Support for Dementia treatment safe for humans?

The research does not provide specific safety data for the Caregiver Support for Dementia treatment, but it suggests that similar interventions, like peer mentoring and educational support, have been successfully used in other conditions without reported safety concerns. ^{1 2 4 5 6}

How is the PERSEVERE treatment different from other treatments for Lewy body dementia?

PERSEVERE is unique because it uses peer mentor support and caregiver education specifically tailored for Lewy body dementia, incorporating input from caregivers themselves, which is not commonly found in other treatments for this condition. ^{1 2 4 5 6}

What is the purpose of this trial?

Lewy Body Dementia (LBD) is the second most common form of degenerative dementia, affecting at least 2.4 million US adults, and the overwhelming majority of persons living with LBD (PLBD) are cared for by family caregivers. LBD caregiver strain: 1) exceeds that of non-LBD dementia caregivers; 2) worsens caregiver physical and mental health; and 3) increases the risk of PLBD hospitalization and institutionalization. LBD progression is complicated by combined motor, cognitive, and neuropsychiatric decline, and is punctuated by falls, infections, dehydration, and neuropsychiatric symptoms leading to acute healthcare utilization. Although family caregivers are uniquely positioned to identify and manage these challenges, which may avert emergency department visits and reduce morbidity, many caregivers lack the knowledge, skills, confidence, resources, and support to do so. The study team aims to 1) quantify the impact of PERSEVERE on caregiver knowledge, attitudes, mastery, and strain; 2) identify the intervention and mentor factors determining implementation fidelity; and 3) test the effects of PERSEVERE on PLBD quality of life and healthcare utilization. This will be accomplished in an NIH Behavioral Model Stage II national, randomized, attention-controlled, 12-week trial of PERSEVERE in 502 LBD caregivers in partnership with the Lewy Body Dementia Association, Parkinson's Foundation, and LBD Caregiver Advisors. The study team will match intervention arm caregivers with a trained peer mentor who will coach them through a modular, theory-based curriculum on LBD knowledge and social support. Attention-control participants will receive weekly, curated links to educational materials. The study team will identify immediate and delayed intervention effects, including mediators of strain at 12 weeks, and caregiver strain and PLBD outcomes at nine months. Implementation fidelity and PLBD healthcare utilization will be tracked biweekly. Qualitative methods will explore the intervention- and mentor-specific factors predicting fidelity, mentee outcomes, and retention. Remote recruitment, mentoring, and community engagement strategies will maximize accessibility and inclusion of underrepresented caregiver groups. Results will illuminate the extent to which leveraging prior LBD caregivers as expert interventionists can improve current caregiver outcomes, and in turn, PLBD outcomes. These results will inform future adaptation and dissemination of this model for other conditions.

Research Team

Jori E Fleisher, MD MSCE

Principal Investigator

Rush University Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Learning to PERSEVERE: A pilot study of peer mentor support and caregiver education in Lewy body dementia. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Caregiver burden in family carers of people with dementia with Lewy bodies and Alzheimer's disease. [2022]

3. England 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. [2021]

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

Lewy body dementia: caregiver burden and unmet needs. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Evaluation of START (STrAtegies for RelaTives) adapted for carers of people with Lewy body dementia. [2023]

6. England 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. [2022]