- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04649164
Learning to PERSEVERE: Peer Mentor Support and Caregiver Education in Lewy Body Dementia
Study Overview
Status
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Illinois
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Chicago, Illinois, United States, 60612
- Rush University Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Focus group participants
Subjects participating in focus groups will be either:
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. |
Participation in a 2-3 hour focus group to review pilot and revised materials and provide feedback
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Other: Peer mentors
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.
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Sixteen-week modular curriculum with printed/online workbook, additional resources, and weekly phone discussion with Lewy Body Dementia peer mentor.
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Experimental: Caregiver mentees
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.
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Sixteen-week modular curriculum with printed/online workbook, additional resources, and weekly phone discussion with Lewy Body Dementia peer mentor.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mastery Scale
Time Frame: Pre- and post-mentor training; pre- and post-mentoring intervention for mentees (16 weeks)
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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
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Pre- and post-mentor training; pre- and post-mentoring intervention for mentees (16 weeks)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Loneliness Scale
Time Frame: pre- and post-mentoring intervention for mentees (16 weeks)
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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
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pre- and post-mentoring intervention for mentees (16 weeks)
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Short Zarit Burden Interview (ZBI-12)
Time Frame: pre- and post-mentoring intervention for mentees (16 weeks)
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A 12-item, validated measurement of caregiver burden in older adults.
Scores range from 0-48, with higher scores indicating greater caregiver burden
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pre- and post-mentoring intervention for mentees (16 weeks)
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Hospital Anxiety and Depression Scale (HADS) - Anxiety Score
Time Frame: 16 weeks
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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
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16 weeks
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Geriatric Depression Scale - Short Form (GDS-SF)
Time Frame: 16 weeks
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Brief, 15-item, highly validated scale for measuring depression in older adults, total possible range of 0-15, where a score >5 suggests depression
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16 weeks
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Dementia Attitudes Scale (DAS)
Time Frame: pre- and post-mentoring intervention for mentees (16 weeks)
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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
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pre- and post-mentoring intervention for mentees (16 weeks)
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Duration of Mentoring Calls
Time Frame: Assessed at weeks 2, 4, 6, 8, 10, 12, 14, 16; average value calculated at week 16
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Online structured survey of mentoring phone call duration, in minutes
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Assessed at weeks 2, 4, 6, 8, 10, 12, 14, 16; average value calculated at week 16
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Hospital Anxiety and Depression Scale - Depression Score
Time Frame: 16 weeks
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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
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16 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency of Mentoring Calls
Time Frame: Assessed at 2, 4, 6, 8, 10, 12, 14, and 16 weeks; summed total phone calls at week 16 reported
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Online structured survey of number of calls
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Assessed at 2, 4, 6, 8, 10, 12, 14, and 16 weeks; summed total phone calls at week 16 reported
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Frequency of Missed Calls
Time Frame: Assessed at 2, 4, 6, 8, 10, 12, 14, and 16 weeks; summed total missed phone calls at week 16 reported
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Online structured survey of number of missed calls since last survey
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Assessed at 2, 4, 6, 8, 10, 12, 14, and 16 weeks; summed total missed phone calls at week 16 reported
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Dropout Rate of Mentors and Mentees, Respectively
Time Frame: Sixteen weeks
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Proportion of mentors and mentees, respectively, not completing study per protocol
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Sixteen weeks
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jori E Fleisher, MD MSCE, Rush University Medical Center, Department of Neurological Scienecs
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20030604
- 5P30AG064200-02 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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