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Effects of Peer Mentoring on Caregivers of Patients With Acquired Brain Injury

Primary Purpose

Acquired Brain Injury, Family Members

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
one-to-one peer mentoring
Sponsored by
Shepherd Center, Atlanta GA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Acquired Brain Injury focused on measuring Peer-to-peer mentoring in self management, Acquired Brain Injury, Family Caregivers, Caregiver stress and burden

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patient admitted for rehabilitation off acquired brain injury Planned discharge to home Family caregiver aged 18 years or older English-speaking

Exclusion Criteria:

  • Discharge location is not home

Sites / Locations

  • Shepherd Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

One-to-One Peer Mentoring

Usual Care

Arm Description

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.

Participants received the usual discharge planning and family support services offered by the ABI program. These services include nurse instruction in care routines, case management support for discharge, peer support services, referral to family counseling and community services as indicated, and general information resources about brain injury. Participants in both the intervention and usual care groups also had access to the online peer support community created for ABI caregivers (facebook.com/shepherdbi.peers). In addition, usual care participants could request one-to-one visits with peer mentors and, indeed, most usual care participants received at least one peer mentoring visit.

Outcomes

Primary Outcome Measures

Participation in family support services
Number of peer support meetings, family orientation classes, and caregiver self-management classes attended by family caregivers during the inpatient stay.
Change in Kingston Caregiver Stress Scale (KCSS) scores
Caregiver stress and burden; scores range from 10-50; higher score reflects higher stress
Change in Patient Health Questionnaire - 9 (PHQ-9) scores
Caregiver depressive symptoms; scores range from 0-27; higher score reflects higher depression

Secondary Outcome Measures

Full Information

First Posted
April 8, 2021
Last Updated
April 15, 2021
Sponsor
Shepherd Center, Atlanta GA
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1. Study Identification

Unique Protocol Identification Number
NCT04851431
Brief Title
Effects of Peer Mentoring on Caregivers of Patients With Acquired Brain Injury
Official Title
Effects of Peer Mentoring on Caregivers of Patients With Acquired Brain Injury
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
January 8, 2019 (Actual)
Primary Completion Date
January 30, 2021 (Actual)
Study Completion Date
January 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shepherd Center, Atlanta GA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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). 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. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acquired Brain Injury, Family Members
Keywords
Peer-to-peer mentoring in self management, Acquired Brain Injury, Family Caregivers, Caregiver stress and burden

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
One-to-One Peer Mentoring
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Participants received the usual discharge planning and family support services offered by the ABI program. These services include nurse instruction in care routines, case management support for discharge, peer support services, referral to family counseling and community services as indicated, and general information resources about brain injury. Participants in both the intervention and usual care groups also had access to the online peer support community created for ABI caregivers (facebook.com/shepherdbi.peers). In addition, usual care participants could request one-to-one visits with peer mentors and, indeed, most usual care participants received at least one peer mentoring visit.
Intervention Type
Behavioral
Intervention Name(s)
one-to-one peer mentoring
Intervention Description
Weekly meetings with a peer family caregiver
Primary Outcome Measure Information:
Title
Participation in family support services
Description
Number of peer support meetings, family orientation classes, and caregiver self-management classes attended by family caregivers during the inpatient stay.
Time Frame
Attendance documented for all classes and meetings held during patients' inpatient stay; average inpatient length of stay is 52 days
Title
Change in Kingston Caregiver Stress Scale (KCSS) scores
Description
Caregiver stress and burden; scores range from 10-50; higher score reflects higher stress
Time Frame
1) baseline, at time of enrollment in the study; 2) within 72 hours of discharge to home; 3) 30-days post-discharge
Title
Change in Patient Health Questionnaire - 9 (PHQ-9) scores
Description
Caregiver depressive symptoms; scores range from 0-27; higher score reflects higher depression
Time Frame
1) baseline, at time of enrollment in the study; 2) within 72 hours of discharge to home; 3) 30-days post-discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patient admitted for rehabilitation off acquired brain injury Planned discharge to home Family caregiver aged 18 years or older English-speaking Exclusion Criteria: Discharge location is not home
Facility Information:
Facility Name
Shepherd Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effects of Peer Mentoring on Caregivers of Patients With Acquired Brain Injury

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