Peer support trial aims to ease the heavy burden on lewy body dementia caregivers
NCT ID NCT06389032
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a 12-week program called PERSEVERE for 502 family caregivers of people with Lewy body dementia (LBD). Caregivers are matched with a trained peer mentor who guides them through lessons on LBD and provides support. The goal is to see if this reduces caregiver strain, improves their attitudes and knowledge, and boosts the quality of life for the person with LBD, compared to just receiving educational links.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 622 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2024
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Peer Mentors 1. Participants must be 18 years of age or older. 2. participant must be English-speaking. 3. Participant must be US-dwelling. 4. Participants must be either: 1. Individuals currently cohabitating with or spending at least 10 hours weekly on caregiving for a family member diagnosed with LBD, as measured by LBCRS score ≥ 3, OR 2. met this criterion in the past if the family member with LBD is deceased. 5. Each participant must have access to and comfort with telephone use, including adequate hearing or appropriate assistive devices to communicate by phone. 6. Each participant must have access to and comfort with internet use, including a working email address and adequate vision or appropriate assistive devices to be able to open and read email communications and participate in an online mentor training session. 7. Each participant must demonstrate the capacity to consent to research participation. 8. Each participant must not have any known terminal diagnoses or life expectancy less than 2 years, by self-report. 9. If PLBD is alive, their cognitive or visual hallucinations have been present for 3 or more years, or between 2-3 years and caregiver actively opts for the mentor role after review of roles and responsibilities with a study team member. 2. Caregivers: 1. Participants must be 18 years of age or older. 2. participant must be English-speaking. 3. Participant must be US-dwelling. 4. Participants must be either: 1. Individuals currently cohabitating with or spending at least 10 hours weekly on caregiving for a family member diagnosed with LBD, as measured by LBCRS score ≥ 3, OR 2. met this criterion in the past if the family member with LBD is deceased. 5. Caregiver must have access to and comfort with telephone use, including adequate hearing or appropriate assistive devices to communicate by phone 6. Caregiver must have access to and comfort with internet use, including a working email address and adequate vision or appropriate assistive devices to be able to open and read email communications and participate in an online mentor training session. 7. Caregiver must demonstrate capacity to consent to research participation. 8. Caregiver must not have any known terminal diagnoses or life expectancy less than 2 years, by self-report 9. PLBD cognitive symptom or visual hallucination onset within the past two years, OR symptoms for 2-3 years and after one-on-one explanation of mentor role and responsibilities with study team member, does not feel confident in ability to serve as a mentor, opts for the role of caregiver participant and being randomized to PERSEVERE or attention control. Exclusion Criteria: 1. Peer mentors 1. Individual is less than 18 years of age. 2. Individual is not English-speaking. 3. Individual is not US-dwelling. 4. Individual who does/did not cohabitate with or spend at least 10 hours weekly on caregiving. 5. Individual was paid for more than 50% of their caregiving responsibilities. 6. Individual does not have access to or comfort with telephone use or lacks adequate hearing or appropriate assistive devices to communicate by phone. 7. Individual does not have access to or comfort with internet use, including a working email address or adequate vision or appropriate assistive devices to be able to open and read email communications and participate in an online mentor training session. 8. Individual lacks capacity to consent to research participation. 9. PHQ-9 greater than 14, indicating severe depression. 10. PHQ-9 question 9 (suicidal ideation) greater than 1. 11. BGQ greater than 5, indicating complicated grief. 12. Individual endorses a known terminal diagnosis or life expectancy less than 2 years, by self-report. 13. PLBD cognitive symptom or visual hallucination onset less than 2 years (meeting this criterion qualifies individual as caregiver participant instead) 14. PLBD cognitive symptom or visual hallucination onset 2-3 years ago but after one-on-one explanation of mentor role and responsibilities with study team member, does not feel confident in ability to serve as a mentor; may opt for the role of caregiver participant and being randomized to PERSEVERE or attention control. 2. Caregivers: 1. Caregiver is less than 18 years of age. 2. Caregiver is not English-speaking. 3. Caregiver is not US-dwelling. 4. Caregiver's PLBD scores 0-2 on LBCRS 5. Caregiver does not cohabitate with or spend at least 10 hours weekly on caregiving. 6. Caregiver is paid for more than 50% of their caregiving responsibilities. 7. PLBD is living in a nursing facility at the time of screening. 8. Caregiver does not have access to or comfort with telephone use, or lacks adequate hearing or appropriate assistive devices to communicate by phone. 9. Caregiver does not have access to or comfort with internet use, including a working email address or adequate vision or appropriate assistive devices to be able to open and read email communications. and participate in an online mentor training session. 10. PHQ-9 greater than 14, indicating severe depression. 11. PHQ-9 question 9 (suicidal ideation) greater than 1. 12. Caregiver lacks capacity to consent to research participation. 13. Caregiver endorses a known terminal diagnosis or life expectancy less than 2 years, by self-report. 14. PLBD cognitive symptoms or visual hallucinations have been present. for less than 3 years, or between 2-3 years and caregiver actively opts for the mentor role.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Rush University Medical Center
Chicago, Illinois, 60612, United States
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