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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: Active NA study of Dementia With Lewy Bodies and Lewy Body Dementia, sponsored by Rush University Medical Center.
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. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
An 18-item validated measurement of strain of caregiving among informal caregivers. Scores range from 0-72, with higher scores indicating higher caregiver strain.
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 |
What the registry record for NCT06389032 still lists
NCT06389032 is an interventional study that assigns participants to a tested intervention. The registered 622 participants enrollment target is mid-sized for trials with a published cap, above the 443-participant average among 22 other Dementia With Lewy Bodies trials with a reported enrollment target (40% higher).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06389032's enrollment target sits among peer trials
622 6th of 22 higher than 17 of 22 other Dementia With Lewy Bodies trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Dementia With Lewy Bodies trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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