PERSEVERE: Peer Mentor Support and Caregiver Education in Lewy Body Dementia

NCT06389032 | Active Not Recruiting DMC

• 2 other identifiers: 210415031R01AG079128-01A1
• Study Type: interventional
• Target: 622
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lewy Body Dementia; Parkinson Disease Dementia; Dementia With Lewy Bodies; Lewy Body Disease

Outcome Measures

Primary Outcomes (5)

• Multidimensional Caregiver Strain Index (MCSI)

  An 18-item validated measurement of strain of caregiving among informal caregivers. Scores range from 0-72, with higher scores indicating higher caregiver strain.

  Assessed at Weeks 0,12 and 38.

• Quality of Life in Alzheimer's Disease ( QoL-AD)

  A 13-item scale for quality of life for individuals with dementia, validated for caregiver to proxy report on person with dementia's behalf.

  Assessed at Weeks 0, 12 and 38.

• Dementia Attitudes Scale (DAS)

  A validated, 20-item scale measuring participants' attitudes toward dementia and individuals with dementia. Scores can range from 7-140, with higher scores indicating more positive attitudes

  Assessed at Weeks 0,12 and 38

• LBD Knowledge Test ( LBDK)

  A 12-item, multiple-choice test created by the study team to assess participants' level of knowledge of LBD, validated initially in a cohort of healthcare professionals (Hess SP et al, 2022). Calculated scores range from 0-100, with higher scores indicating a greater degree of knowledge of LBD and its effects.

  Assessed at Weeks 0, 12 and 38.

• Baseline PLBD Fall Frequency and Healthcare Utilization Questionnaire

  A 19-item questionnaire, developed in 2020 by PI and study team to quantify number of falls, number of healthcare utilizations, and causes of hospital encounters for a patient for whom mentees are caring. Each item scored individually, with no summary scale or total score.

  Assessed at Week- 0 (Baseline)

Secondary Outcomes (3)

• Fortinsky Caregiver Self-Efficacy Score

  Assessed at Weeks 0, 12 and 38.

• Multidimensional Scale of Perceived Social Support (MSPSS)

  Assessed at Weeks 0,12 and 38.

• Pearlin Mastery Scale

  Assessed at Weeks 0,12 and 38

Other Outcomes (3)

• Frequency and Duration of Mentoring Calls

  Assessed at 2,4,6,8,10 and 12 weeks (Biweekly x 12 weeks)

• Study adherence of Mentors and Mentees

  Assessed at Week 12 and Week 38

• Coverage of target topics; additional topics discussed

  Assessed Weeks 2,4,6,8,10 and 12 weeks (Biweekly x 12 weeks)

Study Arms (3)

Caregiver Mentees

EXPERIMENTAL

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.

Behavioral: Peer Mentor Support and Caregiver Education

Education Group

ACTIVE COMPARATOR

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.

Behavioral: Caregiver Education

Peer mentors

OTHER

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.

Behavioral: Peer Mentor Support and Caregiver Education

Interventions

Peer Mentor Support and Caregiver Education BEHAVIORAL

12- week modular curriculum with handbook (PDF and Website version), additional resources and weekly phone discussions with Lewy Body Dementia (LBD) peer mentor/mentee.

Caregiver Mentees; Peer mentors

Caregiver Education BEHAVIORAL

12-weeks of receiving weekly curated list of Lewy Body Dementia (LBD) educational resources based on the weekly topics via email.

Education Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Peer Mentors
• Participants must be 18 years of age or older.
• participant must be English-speaking.
• Participant must be US-dwelling.
• Participants must be either:
• Individuals currently cohabitating with or spending at least 10 hours weekly on caregiving for a family member diagnosed with LBD, as measured by LBCRS score ≥ 3, OR
• met this criterion in the past if the family member with LBD is deceased.
• Each participant must have access to and comfort with telephone use, including adequate hearing or appropriate assistive devices to communicate by phone.
• Each participant must have access to and comfort with internet use, including a working email address and adequate vision or appropriate assistive devices to be able to open and read email communications and participate in an online mentor training session.
• Each participant must demonstrate the capacity to consent to research participation.
• Each participant must not have any known terminal diagnoses or life expectancy less than 2 years, by self-report.
• If PLBD is alive, their cognitive or visual hallucinations have been present for 3 or more years, or between 2-3 years and caregiver actively opts for the mentor role after review of roles and responsibilities with a study team member.
• Caregivers:
• Participants must be 18 years of age or older.
• participant must be English-speaking.

You may not qualify if:

• Peer mentors
• Individual is less than 18 years of age.
• Individual is not English-speaking.
• Individual is not US-dwelling.
• Individual who does/did not cohabitate with or spend at least 10 hours weekly on caregiving.
• Individual was paid for more than 50% of their caregiving responsibilities.
• Individual does not have access to or comfort with telephone use or lacks adequate hearing or appropriate assistive devices to communicate by phone.
• Individual does not have access to or comfort with internet use, including a working email address or adequate vision or appropriate assistive devices to be able to open and read email communications and participate in an online mentor training session.
• Individual lacks capacity to consent to research participation.
• PHQ-9 greater than 14, indicating severe depression.
• PHQ-9 question 9 (suicidal ideation) greater than 1.
• BGQ greater than 5, indicating complicated grief.
• Individual endorses a known terminal diagnosis or life expectancy less than 2 years, by self-report.
• PLBD cognitive symptom or visual hallucination onset less than 2 years (meeting this criterion qualifies individual as caregiver participant instead)
• PLBD cognitive symptom or visual hallucination onset 2-3 years ago but after one-on-one explanation of mentor role and responsibilities with study team member, does not feel confident in ability to serve as a mentor; may opt for the role of caregiver participant and being randomized to PERSEVERE or attention control.

Sponsors & Collaborators

• Rush University Medical Center: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Lewy Body Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dementia; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Jori E Fleisher, MD MSCE

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator: Jori E Fleisher, MD MSCE, Rush University Medical Center, Department of Neurological Sciences

Study Record Dates

• First Submitted: April 24, 2024
• First Posted: April 29, 2024
• Study Start: May 13, 2024
• Primary Completion (Estimated): October 15, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)