Support and education for caregivers of people with Lewy Body Dementia

PERSEVERE in Lewy Body Dementia: A Randomized, Controlled Trial of Peer Mentor Support and Caregiver Education

This study is testing whether support and education for caregivers of people with Lewy Body Dementia can help them feel more confident and less stressed in their role.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 622 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Rush University Medical Center (Academic / other)
• Locations: 1 site (Chicago, Illinois)
• Trial ID: NCT06389032 on ClinicalTrials.gov

What this trial studies

This study focuses on providing peer mentor support and caregiver education to individuals caring for family members with Lewy Body Dementia (LBD). It aims to quantify the impact of these interventions on caregiver knowledge, attitudes, mastery, and strain. Given the unique challenges faced by LBD caregivers, the study seeks to enhance their skills and confidence in managing the complexities of the condition, potentially reducing emergency department visits and improving overall caregiver well-being.

Who should consider this trial

Good fit: Ideal candidates for this study are family caregivers who are currently providing care for a loved one diagnosed with Lewy Body Dementia or have done so in the past.

Not a fit: Patients who are not currently involved in caregiving or those who do not have a family member diagnosed with Lewy Body Dementia may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly improve the quality of life for both caregivers and patients by reducing caregiver strain and enhancing care management.

How similar studies have performed: While there has been considerable research on caregiver interventions for dementia, this specific approach targeting LBD caregivers is relatively novel and has not been extensively tested.

Eligibility criteria

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.

Where this trial is running

Chicago, Illinois

• Rush University Medical Center — Chicago, Illinois, United States (Recruiting)

Study contacts

• Principal investigator: Jori E Fleisher, MD MSCE — Rush University Medical Center
• Study coordinator: PERSEVERE Study Team

Conditions Lewy Body Dementia; Parkinson Disease Dementia; Dementia With Lewy Bodies; Lewy Body Disease