Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04649164 |
Other study ID # |
20030604 |
Secondary ID |
5P30AG064200-02 |
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
November 2, 2020 |
Est. completion date |
August 31, 2021 |
Study information
Verified date |
January 2023 |
Source |
Rush University Medical Center |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical 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. 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.
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.