PERSEVERE: Peer Mentor Support and Caregiver Education in Lewy Body Dementia

Description

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 intervention- and mentor-specific factors predicting fidelity, mentee outcomes, and retention. Remote recruitment, mentoring, and community engagement strategies will maximize accessibility and inclusion of underrepresented caregiver groups. Results will illuminate the extent to which leveraging prior LBD caregivers as expert interventionists can improve current caregiver outcomes, and in turn, PLBD outcomes. These results will inform future adaptation and dissemination of this model for other conditions.

Conditions

Lewy Body Dementia, Parkinson Disease Dementia, Dementia With Lewy Bodies, Lewy Body Disease

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Study Overview

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Study Details

Study overview

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 intervention- and mentor-specific factors predicting fidelity, mentee outcomes, and retention. Remote recruitment, mentoring, and community engagement strategies will maximize accessibility and inclusion of underrepresented caregiver groups. Results will illuminate the extent to which leveraging prior LBD caregivers as expert interventionists can improve current caregiver outcomes, and in turn, PLBD outcomes. These results will inform future adaptation and dissemination of this model for other conditions.

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

PERSEVERE: Peer Mentor Support and Caregiver Education in Lewy Body Dementia

Condition
Lewy Body Dementia
Intervention / Treatment

-

Contacts and Locations

Chicago

Rush University Medical Center, Chicago, Illinois, United States, 60612

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Rush University Medical Center,

Dr. Jori Fleisher, MD MSCE, PRINCIPAL_INVESTIGATOR, Rush University Medical Center

Study Record Dates

2028-06-30