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

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Peer mentor support and caregiver intervention
Focus group to provide feedback on educational materials and mentoring program
Sponsored by
Rush University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lewy Body Disease focused on measuring caregiver strain, caregiving mastery, peer mentor, caregiver education, Lewy Body Disease, Parkinson's Disease, social support

Eligibility Criteria

21 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Focus group participants

    1. Each subject must be 21 years of age or older. A subject may identify as any sex, any race, and any ethnicity.
    2. 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.

  2. Peer mentors

    1. Each subject must be 21 years of age or older. A subject may identify as any sex, any race, and any ethnicity.
    2. 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

  3. Caregiver mentees

    1. Each subject must be 21 years of age or older. A subject may identify as any sex, any race, and any ethnicity.
    2. Each subject must be a non-professional, unpaid caregiver, as defined above, of a community-dwelling LBD patient.
    3. Each subject must be interested in improving their caregiving mastery.
    4. Each subject must be primarily English-speaking.
    5. Each subject must have a working email address and internet access.
    6. 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 mentor.

Exclusion Criteria:

  1. 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.
  2. Subjects who are primarily non-English-speaking.
  3. Terminal illness (life expectancy of < 12 months).

Sites / Locations

  • Rush University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Experimental

Arm Label

Focus group participants

Peer mentors

Caregiver mentees

Arm Description

Subjects participating in focus groups will be either: caregiver mentees in our previous peer mentoring study peer mentors and completed 16 weeks of mentoring in our previous peer mentoring study 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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Loneliness Scale
A 3-item, validated measurement of a participant's feelings of isolation or disconnectedness. Scores can range from 3-9, with higher scores indicating greater loneliness
Short Zarit Burden Interview (ZBI-12)
A 12-item, validated measurement of caregiver burden in older adults. Scores range from 0-48, with higher scores indicating greater caregiver burden
Hospital Anxiety and Depression Scale (HADS) - Anxiety Score
Anxiety subscale of the Hospital Anxiety and Depression Scale, where seven items measure anxiety. Total possible subscale range 0-21, where higher scores indicate worse outcome/more anxiety. A score >8 on the subscale indicates probable symptoms
Geriatric Depression Scale - Short Form (GDS-SF)
Brief, 15-item, highly validated scale for measuring depression in older adults, total possible range of 0-15, where a score >5 suggests depression
Dementia Attitudes Scale (DAS)
A validated, 20-item scale measuring participants' attitudes toward dementia and individuals with dementia. Scores can range from 7-140, with higher scores indicating more positive attitudes
Duration of Mentoring Calls
Online structured survey of mentoring phone call duration, in minutes
Hospital Anxiety and Depression Scale - Depression Score
Depression subscale of the Hospital Anxiety and Depression Scale, where seven items measure depression. Total possible subscale range 0-21, where higher scores indicate worse outcome/more depression. A score >8 on the subscale indicates probable symptoms

Full Information

First Posted
November 24, 2020
Last Updated
January 6, 2023
Sponsor
Rush University Medical Center
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT04649164
Brief Title
Learning to PERSEVERE: Peer Mentor Support and Caregiver Education in Lewy Body Dementia
Official Title
Learning to PERSEVERE: Peer Mentor Support and Caregiver Education in Lewy Body Dementia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
November 2, 2020 (Actual)
Primary Completion Date
August 31, 2021 (Actual)
Study Completion Date
August 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rush University Medical Center
Collaborators
National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Scientific Premise. PERSEVERE is a theory-based intervention that applies Social Cognitive Theory constructs to the revised Stress Process Model to improve caregiving mastery and ultimately, outcomes. PERSEVERE targets education about common causes of hospitalization in LBD patients combined with social support from trained peer mentors to enhance caregivers' mastery and LBD knowledge. Social Cognitive Theory (SCT) proposes that behavior change is dynamic, affected by expectations, observational learning, and reciprocal influences from the environment. Study procedures. Aim 1 (Fall 2020): Revise the mentor training curriculum, conversation guides, and resource handbook. The team will convene focus groups of previously trained mentors, LBD caregivers, and LBD professionals, present each group with the original mentor curriculum (training presentation slides and handbook) and the proposed educational resources for inclusion in the revised curriculum and obtain their feedback. Framework analysis will be used to guide the revision of the mentoring curriculum, with provision of practical checklists, goal setting, and step-by-step guides for key areas of LBD caregiving mastery in addition to social support, structured as the 16-week PERSEVERE curriculum. Aim 2 (Winter 2021): Recruit and screen 36 peer mentors as PERSEVERE is being revised, followed by two 6-7 hour training sessions for mentors in early 2021. Each selected mentor will attend one training session, where the following content will be delivered: 1) study logistics, expectations, and informed consent; 2) baseline mentor data collection; 3) active listening, mentoring, goal- and boundary-setting; 4) overview of LBD, risk factors for hospitalization, impact on caregiver; and 5) practical approaches to symptom management and caregiving issues. The week-by-week PERSEVERE curriculum will be presented along with the accompanying handbook. The investigators will solicit questions and role-play conversations. The study team will encourage mentors to direct their mentees to call their respective medical teams with specific medical questions, however the study team will inform the mentors that they may contact the study team directly for non-emergent advice and resources. Mentors will complete post-training assessments and will receive a training stipend. Mentors' caregiver mastery will be assessed using Pearlin and Schooler's scale pre- and post-training. Aim 3 (Spring-Summer 2021): Recruit 30 LBD caregivers and conduct baseline assessments including demographics, relationship to LBD patient, and duration of caregiving. Mentors will be matched to caregivers by relationship to LBD patient, then by sex and age, as much as possible. Mentor-mentee pairs will be formed and the PERSEVERE handbook and contact information will be distributed. 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. Discussions are not scripted and will not necessarily be limited to that week's topics. Mentors and mentees will complete online study diaries every 2 weeks, assessing intervention fidelity. Up to 3 reminders will be sent to complete each study diary, and if missing, a team member will call the participant(s). Mentors will participate in a total of 4 recorded monthly conferences with the study team. Mentees' caregiver mastery, strain, anxiety, and depression will be assessed at baseline and after the 16-week program. Feasibility will be assessed via online surveys and study team phone call follow-up. This pilot study will determine the necessary qualities of mentors and matching, the content of the mentor training and PERSEVERE handbook, and the effect sizes of the intervention to determine the sample size for a forthcoming R01.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
87 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Focus group participants
Arm Type
Other
Arm Description
Subjects participating in focus groups will be either: caregiver mentees in our previous peer mentoring study peer mentors and completed 16 weeks of mentoring in our previous peer mentoring study 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.
Arm Title
Peer mentors
Arm Type
Other
Arm Description
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.
Arm Title
Caregiver mentees
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Peer mentor support and caregiver intervention
Intervention Description
Sixteen-week modular curriculum with printed/online workbook, additional resources, and weekly phone discussion with Lewy Body Dementia peer mentor.
Intervention Type
Other
Intervention Name(s)
Focus group to provide feedback on educational materials and mentoring program
Intervention Description
Participation in a 2-3 hour focus group to review pilot and revised materials and provide feedback
Primary Outcome Measure Information:
Title
Mastery Scale
Description
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
Time Frame
Pre- and post-mentor training; pre- and post-mentoring intervention for mentees (16 weeks)
Secondary Outcome Measure Information:
Title
Loneliness Scale
Description
A 3-item, validated measurement of a participant's feelings of isolation or disconnectedness. Scores can range from 3-9, with higher scores indicating greater loneliness
Time Frame
pre- and post-mentoring intervention for mentees (16 weeks)
Title
Short Zarit Burden Interview (ZBI-12)
Description
A 12-item, validated measurement of caregiver burden in older adults. Scores range from 0-48, with higher scores indicating greater caregiver burden
Time Frame
pre- and post-mentoring intervention for mentees (16 weeks)
Title
Hospital Anxiety and Depression Scale (HADS) - Anxiety Score
Description
Anxiety subscale of the Hospital Anxiety and Depression Scale, where seven items measure anxiety. Total possible subscale range 0-21, where higher scores indicate worse outcome/more anxiety. A score >8 on the subscale indicates probable symptoms
Time Frame
16 weeks
Title
Geriatric Depression Scale - Short Form (GDS-SF)
Description
Brief, 15-item, highly validated scale for measuring depression in older adults, total possible range of 0-15, where a score >5 suggests depression
Time Frame
16 weeks
Title
Dementia Attitudes Scale (DAS)
Description
A validated, 20-item scale measuring participants' attitudes toward dementia and individuals with dementia. Scores can range from 7-140, with higher scores indicating more positive attitudes
Time Frame
pre- and post-mentoring intervention for mentees (16 weeks)
Title
Duration of Mentoring Calls
Description
Online structured survey of mentoring phone call duration, in minutes
Time Frame
Assessed at weeks 2, 4, 6, 8, 10, 12, 14, 16; average value calculated at week 16
Title
Hospital Anxiety and Depression Scale - Depression Score
Description
Depression subscale of the Hospital Anxiety and Depression Scale, where seven items measure depression. Total possible subscale range 0-21, where higher scores indicate worse outcome/more depression. A score >8 on the subscale indicates probable symptoms
Time Frame
16 weeks
Other Pre-specified Outcome Measures:
Title
Frequency of Mentoring Calls
Description
Online structured survey of number of calls
Time Frame
Assessed at 2, 4, 6, 8, 10, 12, 14, and 16 weeks; summed total phone calls at week 16 reported
Title
Frequency of Missed Calls
Description
Online structured survey of number of missed calls since last survey
Time Frame
Assessed at 2, 4, 6, 8, 10, 12, 14, and 16 weeks; summed total missed phone calls at week 16 reported
Title
Dropout Rate of Mentors and Mentees, Respectively
Description
Proportion of mentors and mentees, respectively, not completing study per protocol
Time Frame
Sixteen weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. 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 mentor. Exclusion Criteria: 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jori E Fleisher, MD MSCE
Organizational Affiliation
Rush University Medical Center, Department of Neurological Scienecs
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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