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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

No Placebo-Only Group

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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at 2,4,6,8,10 and 12 weeks (biweekly x 12 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Baseline PLBD Fall Frequency and Healthcare Utilization Questionnaire

Dementia Attitudes Scale (DAS)

LBD Knowledge Test ( LBDK)

+2 more

Secondary study objectives

Fortinsky Caregiver Self-Efficacy Score

Multidimensional Scale of Perceived Social Support (MSPSS)

Pearlin Mastery Scale

Other study objectives

Coverage of target topics; additional topics discussed

Frequency and Duration of Mentoring Calls

Study adherence of Mentors and Mentees

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

Do I qualify?Apply below to find out