Ignite Creation Date:
2024-05-06 @ 3:28 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04649164
Status:
COMPLETED
Last Update Posted:
2023-01-25
First Post:
2020-11-24
Brief Title:
Learning to PERSEVERE Peer Mentor Support and Caregiver Education in Lewy Body Dementia
Sponsor:
Rush University Medical Center
Organization:
Rush University Medical Center
Study Overview
Official Title:
Learning to PERSEVERE Peer Mentor Support and Caregiver Education in Lewy Body Dementia
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Parkinsons 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 teams 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 Schoolers 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 weeks 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 weeks 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 participants 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 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 Schoolers 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 weeks 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 weeks 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 participants 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5P30AG064200-02 | NIH | None | httpsreporternihgovquickSearch5P30AG064200-02 |