protocolSection identificationModule nctId: NCT06389032, orgStudyIdInfo id: 21041503, secondaryIdInfos id: 1R01AG079128-01A1, type: NIH, link: https://reporter.nih.gov/quickSearch/1R01AG079128-01A1, briefTitle: PERSEVERE in Lewy Body Dementia: A Randomized, Controlled Trial of Peer Mentor Support and Caregiver Education, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-10-15, completionDateStruct date: 2028-06-30, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Rush University Medical Center, class: OTHER, collaborators name: National Institute on Aging (NIA), descriptionModule briefSummary: 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.We aim 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. We 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. We 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., conditionsModule conditions: Lewy Body Dementia, conditions: Parkinson Disease Dementia, conditions: Dementia With Lewy Bodies, conditions: Lewy Body Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 622, type: ESTIMATED, armsInterventionsModule interventions name: Peer Mentor Support and Caregiver Education, interventions name: Caregiver Education, outcomesModule primaryOutcomes measure: Multidimensional Caregiver Strain Index (MCSI), primaryOutcomes measure: Quality of Life in Alzheimer's Disease ( QoL-AD), primaryOutcomes measure: Dementia Attitudes Scale (DAS), primaryOutcomes measure: LBD Knowledge Test ( LBDK), primaryOutcomes measure: Baseline PLBD Fall Frequency and Healthcare Utilization Questionnaire, secondaryOutcomes measure: Fortinsky Caregiver Self-Efficacy Score, secondaryOutcomes measure: Multidimensional Scale of Perceived Social Support (MSPSS), secondaryOutcomes measure: Pearlin Mastery Scale, otherOutcomes measure: Frequency and Duration of Mentoring Calls, otherOutcomes measure: Study adherence of Mentors and Mentees, otherOutcomes measure: Coverage of target topics; additional topics discussed, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Rush University Medical Center, city: Chicago, state: Illinois, zip: 60612, country: United States, contacts name: Persevere Study Team, role: CONTACT, phone: 312-563-3300, email: persevere@rush.edu, contacts name: Dr. Jori Fleisher, MD MSCE, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.85003, lon: -87.65005, hasResults: False