Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04851431 |
Other study ID # |
1543747 |
Secondary ID |
|
Status |
Completed |
Phase |
Phase 2
|
First received |
|
Last updated |
|
Start date |
January 8, 2019 |
Est. completion date |
January 30, 2021 |
Study information
Verified date |
April 2021 |
Source |
Shepherd Center, Atlanta GA |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Family caregivers often take on the demands of long-term caregiving after ABI. Early efforts
to prepare family caregivers for the caregiving role after discharge from acute ABI inpatient
rehabilitation may be beneficial in many ways. This study will look at the impact of
participation in a one-to-one peer mentor program on the use of family support services and
caregivers' emotional health and well-being (depression symptoms, stress).
Participants in this study will include caregivers of patient admitted to the Shepherd Center
ABI inpatient rehabilitation unit. Caregivers will be randomly selected to participate in the
one-to-one mentor program. The program will include visits with a peer mentor who is the
caregiver of an individual with an acquired brain injury. Participants will be able to choose
a peer mentor that matches their personal situation and preferences. They will meet with the
peer mentor about once a week during the patient's stay at Shepherd Center and may continue
with phone calls up to 30 days post-discharge. Participants will be asked to complete a brief
evaluation after each peer mentor interaction to determine the value of the interactions and
their interest in continuing visits. Participants will be asked to take part in three
interviews that will last 10-15 minutes. The first will be within the first two weeks at
Shepherd Center and the second will be a few days after discharge. A third interview will be
conducted by phone about 30 days post discharge.
Description:
The one-to-one peer mentor intervention will be evaluated for effectiveness on caregiver
outcomes and use of family support services. 40 participants will be enrolled to assess the
impact of one-on-one peer mentor relationships through the completion of the Kingston
Caregiver Stress Scale (KCSS), Patient Health Questionnaire (PHQ-9), and participation in
family support classes.
Participants will be recruited, based on inclusion and exclusion criteria, via in person
meeting, by the study's research coordinator at Shepherd Center. Once a recruited subject
expresses interest in participating in the study, the research coordinator will go over the
informed consent form with the participant and enroll them into the study.
Once informed consent is obtained, enrolled participants will be asked to answer questions
about their demographics and psychological well-being (PHQ-9 and KCSS). At this time, the
participant will be randomized into the peer mentor intervention group or the control group
(receiving general peer support under usual care).
1. Usual Care Peer Support Family support services offered at Shepherd Center under usual
care involves peer mentoring, community support, brain injury education classes, and
workshops. Within 5-10 days of admission, the caregiver of the patient is introduced to
the peer support team. Caregivers are seen by peer mentors within the family support
services on a referral basis from therapists, nurses, counselors, or physicians or on
request from the caregivers/family. There are no scheduled interactions between peer
support and the caregiver, nor is the caregiver assigned a peer mentor. The family is
made aware of resources, but participation is optional for the family/caregiver. Access
to the ABI Peer Support Facebook page is also available and the page is maintained by
the Shepherd Peer Mentors.
2. One-to-One Mentoring Caregiver will be matched based on characteristics such as age,
date of patient injury, level of patient injury, cause of patient injury, marital
status, work status before and after patient injury, interests, and leisure activities.
After participant is matched with a peer mentor, they will be required to have at least
one weekly one-to-one interaction from time of match until 30 days post- discharge. The
use of family support services by the participant will be monitored by peer mentor
reported interactions, as well as attendance in family support classes. The participant
will be asked to briefly review each weekly scheduled one-to-one interaction to ensure
mentorship needs are being met on behalf of the participant.
Participant use of family support services offered by Shepherd Center will be monitored by
attendance and by self-reported use of resources by caregiver, to peer mentors. Peer support
documentation is recorded after each interaction by the peer mentor. Information logged
includes the date, duration of interaction, type of interaction, and topics discussed.
Attempts made at communicating with caregiver is also documented by the peer mentor within
the database. C
Before discharge from Shepherd Center, the participant will be asked to answer questions
about their medical history, family history, and psychological well-being. At 30 days post
discharge, participants will be asked to answer questions about their psychological
well-being (PHQ-9, KCSS). Those in the intervention group will also be asked to give feedback
on the one-to-one peer mentor program (One-to-one Peer Mentor Initiative Survey).