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NCT06389032 · ClinicalTrials.gov registry record · NA
PERSEVERE: Peer Mentor Support and Caregiver Education in Lewy Body Dementia
A NA study of Dementia With Lewy Bodies and Lewy Body Dementia, sponsored by Rush University Medical Center.
- Active
- Registry status
- NA
- Development phase
- 622
- Enrollment target
- 1
- Study location
NCT06389032 is a NA study of Dementia With Lewy Bodies and Lewy Body Dementia that is active but no longer recruiting, run by Rush University Medical Center. The registered enrollment target is 622 participants, above the 443-participant average among 22 other Dementia With Lewy Bodies trials with a reported enrollment target (40% higher). The trial reports 1 study location across 1 state.
The verdict
NCT06389032, a NA study of Dementia With Lewy Bodies and Lewy Body Dementia, is active but no longer recruiting, sponsored by Rush University Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 622 participants
- Enrollment target
- 1
- Study location
Study 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 int
Conditions Studied
Interventions
- BEHAVIORAL Peer Mentor Support and Caregiver Education
- BEHAVIORAL Caregiver Education
Study Locations (1)
Illinois
- Rush University Medical Center - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 622 participants |
| Start Date | 2024-05-13 |
| Est. Completion | 2028-06-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06389032
The ClinicalTrials.gov registry entry for NCT06389032 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 622 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 443-participant average among 22 other Dementia With Lewy Bodies trials with a reported enrollment target (40% higher). The listed sponsor is Rush University Medical Center, which has 320 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Dementia With Lewy Bodies appearing as the primary indexed condition, and to 2 interventions - of which Peer Mentor Support and Caregiver Education is the first listed.
NCT06389032 reports 1 study location spanning 1 distinct geographic area - top geographies include Illinois.
Frequently Asked Questions
What is clinical trial NCT06389032 about?
NCT06389032 is a clinical study titled "PERSEVERE: Peer Mentor Support and Caregiver Education in Lewy Body Dementia". 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) wor...
What is the current status of trial NCT06389032?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 622 participants. The study started on 2024-05-13. Estimated completion is 2028-06-30.
What conditions does trial NCT06389032 study?
This clinical trial studies the following conditions: Dementia With Lewy Bodies, Lewy Body Dementia, Lewy Body Disease, Parkinson Disease Dementia.
What interventions are being tested in trial NCT06389032?
The interventions under investigation include: Peer Mentor Support and Caregiver Education (BEHAVIORAL), Caregiver Education (BEHAVIORAL).
Who is sponsoring clinical trial NCT06389032?
This trial is sponsored by Rush University Medical Center, which has 320 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06389032 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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