Caregiver Support for Dementia
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Rush University Medical Center
Disqualifiers: Severe depression, Suicidal ideation, Complicated grief, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
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.
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.
12345Is 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.
12456How 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.
12456Eligibility 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
I am over 18, speak English, and live in the US.
Peer Mentors must not have any known terminal diagnoses or life expectancy less than 2 years by self-report
+4 more
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
+3 more
Trial 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
Participant Groups
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.
3Treatment groups
Experimental Treatment
Active Control
Group I: Peer mentorsExperimental Treatment1 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 MenteesExperimental Treatment1 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 GroupActive Control1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Rush University Medical CenterChicago, IL
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Who Is Running the Clinical Trial?
Rush University Medical CenterLead Sponsor
National Institute on Aging (NIA)Collaborator
References
Learning to PERSEVERE: A pilot study of peer mentor support and caregiver education in Lewy body dementia. [2023]Lewy Body Disease (LBD) is the second most common neurodegenerative disorder. Despite high family caregiver strain and adverse patient and caregiver outcomes, few interventions exist for LBD family caregivers. Based on a successful peer mentoring pilot study in advanced Parkinson's Disease, we revised the curriculum of this peer-led educational intervention incorporating LBD caregiver input.
Caregiver burden in family carers of people with dementia with Lewy bodies and Alzheimer's disease. [2022]To characterise the differences in caregiver distress between carers of people diagnosed with dementia with Lewy bodies (DLB) and people with Alzheimer's disease (AD), with a view to differentiating and improving support for caregivers.
Survival time and differences between dementia with Lewy bodies and Alzheimer's disease following diagnosis: A meta-analysis of longitudinal studies. [2021]To synthesize the evidence across longitudinal studies comparing survival in dementia with Lewy bodies (DLB) and Alzheimer's disease (AD).
Lewy body dementia: caregiver burden and unmet needs. [2023]Lewy body dementia (LBD) is a common cause of dementia but to date, little is known about caregiver burden. The Lewy Body Dementia Association (www.LBDA.org) conducted a web-based survey of 962 caregivers (mean age 56 y; 88% women). The most common initial symptoms were cognitive (48%), motor (39%), or both (13%). Caregivers expressed concerns about fear of future (77%), feeling stressed (54%), loss of social life (52%), and uncertainty about what to do next (50%). Caregivers reported moderate-to-severe burden; 80% felt the people around them did not understand their burden and 54% reported feelings of isolation with spousal caregivers reporting more burden than nonspousal caregivers. Only 29% hired in-home assistance, whereas less than 40% used respite or adult day care, geriatric case managers, or attended a support group meeting. Lack of service utilization occurred despite two-thirds of caregivers reporting medical crises requiring emergency services, psychiatric care, or law enforcement. Caregivers reported preferences for web-based information, directories of LBD expert providers, information on LBD research, and location of local support groups. These findings highlight significant unmet needs for LBD caregivers and provide targets for intervention to reduce caregiver burden. Community resources such as the Lewy Body Dementia Association may serve this end, while also providing practical information and support for caregivers.
Evaluation of START (STrAtegies for RelaTives) adapted for carers of people with Lewy body dementia. [2023]Family carers of people with Lewy body dementia (LBD) have a particularly high burden of care, as LBD has a faster rate of decline, greater physical dependence and additional neuropsychiatric disturbances compared with other dementias. Despite this, there are no evidence-based support services designed specifically for LBD carers. STrAtegies for RelaTives (START) is an eight-session, individually delivered coping therapy that has been shown in a randomised controlled trial to reduce depression and anxiety symptoms and increase quality of life in carers of people with dementia, with effects lasting several years. We adapted START for LBD, and piloted its use both face-to-face and on the phone with 10 carers to test acceptability and indications of similar effects in this group. Our findings suggest that the therapy was acceptable and feasible using either delivery mode, providing much appreciated and needed strategies, education and support for carers of people with LBD. Trials of effectiveness are now needed.
The feasibility and acceptability of a psychosocial intervention to support people with dementia with Lewy bodies and family care partners. [2022]Psychosocial support for people with dementia with Lewy bodies (DLB) and family care partners is frequently lacking, despite the need expressed by those with lived experience. Our objective was to examine the feasibility and acceptability of an intervention designed to build coping capability.