Lewy Body DiseaseNCT04649164
Learning to PERSEVERE: Peer Mentor Support and Caregiver Education in Lewy Body Dementia
A study testing Peer mentor support and caregiver intervention and Focus group to provide feedback on educational materials and mentoring program in people with Lewy Body Disease and Parkinson Disease Dementia, run by Rush University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Lewy Body Disease, Parkinson Disease Dementia, Dementia With Lewy Bodies
- What is being tested?
- Peer mentor support and caregiver intervention and Focus group to provide feedback on educational materials and mentoring program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2020to 31 Aug 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
- 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.
Show all 16Show fewer
- 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).
- 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.
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
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.
Read the 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.
- Being tested
- Peer mentor support and caregiver intervention, Focus group to provide feedback on educational materials and mentoring program
- Keywords
- caregiver strain, caregiving mastery, peer mentor, caregiver education, Lewy Body Disease, Parkinson's Disease, social support
- Medical subject headings
- Lewy Body Disease, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer mentor support and caregiver interventionBehavioural
Sixteen-week modular curriculum with printed/online workbook, additional resources, and weekly phone discussion with Lewy Body Dementia peer mentor.
Focus group to provide feedback on educational materials and mentoring programOther
Participation in a 2-3 hour focus group to review pilot and revised materials and provide feedback
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Peer mentor support and caregiver intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Pre- and post-mentor training; pre- and post-mentoring intervention for mentees (16 weeks)
Secondary outcomes (7)
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
Measured: pre- and post-mentoring intervention for mentees (16 weeks)
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
Measured: pre- and post-mentoring intervention for mentees (16 weeks)
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
Measured: 16 weeks
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
Measured: 16 weeks
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
Measured: pre- and post-mentoring intervention for mentees (16 weeks)
Duration of Mentoring Calls
Online structured survey of mentoring phone call duration, in minutes
Measured: Assessed at weeks 2, 4, 6, 8, 10, 12, 14, 16; average value calculated at week 16
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
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start2 Nov 2020
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lewy Body DiseaseStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Jori E Fleisher, MD MSCE, Principal investigator, Rush University Medical Center, Department of Neurological Scienecs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04649164
- Sponsor's protocol ID
- 20030604
- Other IDs
- 5P30AG064200-02
- Status last verified
- Jan 2023
- First submitted
- 24 Nov 2020
- Last updated
- 25 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37385161
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Learning to PERSEVERE: Peer Mentor Support and Caregiver Education in Lewy Body Dementia
- ClinicalTrials.gov ID
- NCT04649164
- Acronym / sponsor ID
- 20030604
- Keywords
- caregiver strain, caregiving mastery, peer mentor, caregiver education, Lewy Body Disease, Parkinson's Disease, social support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 2 Dec 2020 (actual)
- Results
- Posted 25 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Focus group participants | Other | Other: Focus group to provide feedback on educational materials and mentoring programSubjects 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. |
| Peer mentors | Other | Behavioral: Peer mentor support and caregiver interventionMentors 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. |
| Caregiver mentees | Experimental | Behavioral: Peer mentor support and caregiver interventionOnce 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. |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Focus group participants
- Peer mentors
- Caregiver mentees
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peer mentor support and caregiver interventionSixteen-week modular curriculum with printed/online workbook, additional resources, and weekly phone discussion with Lewy Body Dementia peer mentor. | Behavioural | Caregiver mentees, Peer mentors |
| Focus group to provide feedback on educational materials and mentoring programParticipation in a 2-3 hour focus group to review pilot and revised materials and provide feedback | Other | Focus group participants |
Primary outcome
Mastery Scale
Time frame: Pre- and post-mentor training; pre- and post-mentoring intervention for mentees (16 weeks)
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
7 secondary outcomes
Loneliness Scale
Time frame: pre- and post-mentoring intervention for mentees (16 weeks)
Short Zarit Burden Interview (ZBI-12)
Time frame: pre- and post-mentoring intervention for mentees (16 weeks)
Hospital Anxiety and Depression Scale (HADS) - Anxiety Score
Time frame: 16 weeks
Geriatric Depression Scale - Short Form (GDS-SF)
Time frame: 16 weeks
Dementia Attitudes Scale (DAS)
Time frame: pre- and post-mentoring intervention for mentees (16 weeks)
Duration of Mentoring Calls
Time frame: Assessed at weeks 2, 4, 6, 8, 10, 12, 14, 16; average value calculated at week 16
Hospital Anxiety and Depression Scale - Depression Score
Time frame: 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37385161Fleisher 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jori E Fleisher, MD MSCE principal investigator
Rush University Medical Center, Department of Neurological Scienecs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer mentor support and caregiver intervention and Focus group to provide feedback on educational materials and mentoring program in people with Lewy Body Disease and Parkinson Disease Dementia, run by Rush University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mastery Scale (time frame: Pre- and post-mentor training; pre- and post-mentoring intervention for mentees (16 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04649164, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2023.