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Behavioural Intervention
Caregiver Support for Dementia
N/A
Recruiting
Led By Dr. Jori Fleisher, MD MSCE
Research Sponsored by Rush University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed at 2,4,6,8,10 and 12 weeks (biweekly x 12 weeks)
Awards & highlights
Summary
"This trial aims to study the impact of an intervention called PERSEVERE on family caregivers of individuals with Lewy Body Dementia. The study will focus on how PERSEVERE can improve caregiver
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since the interventions involve mentor support and education rather than medical treatments or drugs, there aren't typical side effects. However, participants may experience varying levels of emotional or psychological impact from the involvement.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ assessed at 2,4,6,8,10 and 12 weeks (biweekly x 12 weeks)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed at 2,4,6,8,10 and 12 weeks (biweekly x 12 weeks)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Baseline PLBD Fall Frequency and Healthcare Utilization Questionnaire
Dementia Attitudes Scale (DAS)
LBD Knowledge Test ( LBDK)
+2 moreSecondary outcome measures
Fortinsky Caregiver Self-Efficacy Score
Multidimensional Scale of Perceived Social Support (MSPSS)
Pearlin Mastery Scale
Other outcome measures
Coverage of target topics; additional topics discussed
Frequency and Duration of Mentoring Calls
Study adherence of Mentors and Mentees
Trial Design
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.
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Who is running the clinical trial?
Rush University Medical CenterLead Sponsor
431 Previous Clinical Trials
157,779 Total Patients Enrolled
2 Trials studying Lewy Body Disease
143 Patients Enrolled for Lewy Body Disease
National Institute on Aging (NIA)NIH
1,733 Previous Clinical Trials
28,054,381 Total Patients Enrolled
30 Trials studying Lewy Body Disease
22,770 Patients Enrolled for Lewy Body Disease
Dr. Jori Fleisher, MD MSCEPrincipal InvestigatorRush University Medical Center
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