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

NCT04649164 | Completed Results

• 2 other identifiers: 200306045P30AG064200-02
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators propose to adapt, improve, and implement a peer mentor support and caregiver education (PERSEVERE) program to improve LBD-specific caregiving mastery. Lewy body dementia (LBD) is the second most common dementia, comprising Parkinson's Disease (PD) dementia and Dementia with Lewy Bodies. LBD causes deterioration in multiple cognitive, motor, and neuropsychiatric domains, leading to heavy reliance on family caregivers. Patients with LBD are at a far greater risk of hospitalizations for falls, neuro-psychiatric symptoms, and infections, which are often preventable or treatable at home if recognized. Studies cite a crucial need for education and support of LBD caregivers, who face high rates of caregiver strain and adverse outcomes. Evidence from other chronic conditions supports peer mentoring as a potentially effective intervention to provide education and social support. PERSEVERE builds on our team's ongoing work of creating and testing a peer mentoring program for homebound PD patients' caregivers that has shown promising feasibility and acceptability. In the proposed project, the investigators will convene focus groups of former mentors and mentees, along with current caregivers, to provide formative information to shape the revised PERSEVERE curriculum that will include in-person mentor training and a comprehensive mentoring handbook. The curriculum will focus on key areas of LBD caregiving mastery, including: fall prevention, infections, neuropsychiatric symptoms (particularly hallucinations, delusions, anxiety, and depression), and advance directives. The investigators will enroll and train a new cohort of 36 LBD caregiver peer mentors who will be matched with 30 current LBD caregivers. Each pair will be instructed to speak on a weekly basis, using the 16-week structured curriculum as a framework. The study team will support the mentors with monthly conference calls and day-to-day availability for concerns. The investigators will assess the feasibility and fidelity of the intervention via online study diaries tracking the frequency, duration, and content of calls. During mentor training, the investigators will assess the change in mentors' caregiver mastery and LBD knowledge pre- and post-training. During the PERSEVERE intervention, the investigators will determine the change in mentees' caregiver mastery, LBD knowledge, and loneliness.

Conditions

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

Keywords

caregiver strain; caregiving mastery; peer mentor; caregiver education; Lewy Body Disease; Parkinson's Disease; social support

Outcome Measures

Primary Outcomes (1)

• Mastery Scale

  A 7-item scale measuring the extent to which a participant sees life as being under his/her personal control vs. something that is fatalistically ruled. Scores range from 7 to 28, with higher scores indicating greater levels of mastery

  Pre- and post-mentor training; pre- and post-mentoring intervention for mentees (16 weeks)

Secondary Outcomes (7)

• Loneliness Scale

  pre- and post-mentoring intervention for mentees (16 weeks)

• Short Zarit Burden Interview (ZBI-12)

  pre- and post-mentoring intervention for mentees (16 weeks)

• Hospital Anxiety and Depression Scale (HADS) - Anxiety Score

  16 weeks

• Geriatric Depression Scale - Short Form (GDS-SF)

  16 weeks

• Dementia Attitudes Scale (DAS)

  pre- and post-mentoring intervention for mentees (16 weeks)

Other Outcomes (3)

• Frequency of Mentoring Calls

  Assessed at 2, 4, 6, 8, 10, 12, 14, and 16 weeks; summed total phone calls at week 16 reported

• Frequency of Missed Calls

  Assessed at 2, 4, 6, 8, 10, 12, 14, and 16 weeks; summed total missed phone calls at week 16 reported

• Dropout Rate of Mentors and Mentees, Respectively

  Sixteen weeks

Study Arms (3)

Focus group participants

OTHER

Subjects participating in focus groups will be either: 1. caregiver mentees in our previous peer mentoring study 2. peer mentors and completed 16 weeks of mentoring in our previous peer mentoring study 3. current family caregivers of community-dwelling LBD patients in the Chicago area. The investigators will conduct virtual focus groups using a password-protected videoconference platform. The informed consent process will take place online prior to the focus group. Focus groups will be led by a qualified neuropsychologist using open-ended questions. The aim of these groups is to revise and improve upon our previous peer mentor program's curriculum. Participants will be presented with the previous program's curriculum and a variety of proposed educational resources for inclusion in the revised curriculum. The investigators will obtain participants' feedback. Focus groups will be recorded and transcribed.

Other: Focus group to provide feedback on educational materials and mentoring program

Peer mentors

OTHER

Mentors will attend one 6-7 hour virtual training session. Study expectations and logistics will be reviewed with each potential mentor prior to the training session via phone. Informed consent process will take place online via REDCap prior to the training session. Baseline data will be collected via online surveys. Next, mentors will receive training regarding topics including active listening, mentoring, goal-and boundary-setting, an overview of LBD, risk factors for hospitalization, impact on caregiver, practical approaches to symptom management, and caregiving issues. The study team will present the PERSEVERE curriculum and accompanying handbook. The team will solicit questions and lead roleplay conversations. Finally mentors will complete post-training assessments. Once all caregiver mentees (Arm 3) are recruited, the mentors will contact their mentees once weekly by phone for 16 weeks to deliver the PERSEVERE curriculum.

Behavioral: Peer mentor support and caregiver intervention

Caregiver mentees

EXPERIMENTAL

Once Aim 2 is complete and mentors have been trained, caregiver mentees will be matched with mentors by relationship to LBD patient, then by sex and age, as much as possible. The study team will contact mentees once a match is available for them. The mentee will complete baseline primary and secondary outcome assessments online via REDCap, including: mastery and loneliness scales, Short Zarit Burden Interview, Hospital Anxiety and Depression Scale. The team will provide the mentor's contact information and send the PERSEVERE handbook. Mentoring pairs will begin the 16-week peer mentor program. Pairs will be expected to speak for \>15-30 minutes weekly, and to review that week's PERSEVERE topics in the handbook before or during each call to facilitate meaningful conversations. Mentors and mentees will complete online study diaries every 2 weeks. Upon completion of the 16-week mentor program, mentors and mentees will be sent a link to complete postmentoring assessments online.

Behavioral: Peer mentor support and caregiver intervention

Interventions

Peer mentor support and caregiver intervention BEHAVIORAL

Sixteen-week modular curriculum with printed/online workbook, additional resources, and weekly phone discussion with Lewy Body Dementia peer mentor.

Caregiver mentees; Peer mentors

Focus group to provide feedback on educational materials and mentoring program OTHER

Participation in a 2-3 hour focus group to review pilot and revised materials and provide feedback

Focus group participants

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Focus group participants
• Each subject must be 21 years of age or older. A subject may identify as any sex, any race, and any ethnicity.
• Subjects must be either:
• i. Individuals who served as peer mentors in our previous study of caregiver peer mentoring and completed at least 16 weeks of mentoring. ii. Individuals who were caregiver mentees in our previous study of caregiver peer mentoring who completed 16 weeks of mentoring. iii. Current informal family caregivers of community-dwelling LBD patients in the Chicago area, recruited from Rush University System for Health and Advocate Aurora Health, who have not participated in mentoring. c. Each subject must be primarily English-speaking. d. Each subject must be willing and able to attend a virtual, online focus group via an internet- and video-camera-equipped computer, tablet, or smartphone.
• Peer mentors
• Each subject must be 21 years of age or older. A subject may identify as any sex, any race, and any ethnicity.
• Each subject must be a non-professional caregiver (defined as cohabitating with or spending \>10 hours weekly on unpaid caregiving duties) of LBD patients. Mentors may participate regardless of their loved one's status (living at home, institutionalized, or deceased).
• i. If mentors also receive compensation for a portion of their time spent on caregiving duties through state or community programs, they may participate as long as they cohabitate or spend \>10 hours providing unpaid care to their loved one. c. Each subject must have \>2 years of LBD caregiving experience d. Each subject must be primarily English-speaking. e. Each subject must have a working email address and internet access. f. Each subject must have a working telephone number at which he or she can be reached and which he or she is willing to share with the matched mentee.
• g. Each subject who will attend an online peer mentor training session must have an internet- and video-camera-equipped computer, tablet, or smartphone
• Caregiver mentees
• Each subject must be 21 years of age or older. A subject may identify as any sex, any race, and any ethnicity.
• Each subject must be a non-professional, unpaid caregiver, as defined above, of a community-dwelling LBD patient.
• Each subject must be interested in improving their caregiving mastery.
• Each subject must be primarily English-speaking.
• Each subject must have a working email address and internet access.

You may not qualify if:

• Subjects exhibiting symptoms of a severe psychiatric disorder interfering with their ability to participate in the study, as determined by a study team member or the PI.
• Subjects who are primarily non-English-speaking.
• Terminal illness (life expectancy of \< 12 months).

Sponsors & Collaborators

• Rush University Medical Center: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (1)

• Fleisher JE, Suresh M, Levin ME, Hess SP, Akram F, Dodson D, Tosin M, Stebbins GT, Woo K, Ouyang B, Chodosh J. Learning to PERSEVERE: A pilot study of peer mentor support and caregiver education in Lewy body dementia. Parkinsonism Relat Disord. 2023 Aug;113:105492. doi: 10.1016/j.parkreldis.2023.105492. Epub 2023 Jun 24.

  PMID: 37385161 DERIVED

MeSH Terms

Conditions

Lewy Body Disease; Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dementia; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Jori Fleisher
• Organization: Rush University Medical Center

jori_fleisher@rush.edu

3125632900

Study Officials

• Jori E Fleisher, MD MSCE

  Rush University Medical Center, Department of Neurological Scienecs

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2020
• First Posted: December 2, 2020
• Study Start: November 2, 2020
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: January 25, 2023
• Results First Posted: January 25, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)