NCT04851431

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 8, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 8, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 20, 2021

Completed
Last Updated

April 20, 2021

Status Verified

April 1, 2021

Enrollment Period

2.1 years

First QC Date

April 8, 2021

Last Update Submit

April 15, 2021

Conditions

Keywords

Peer-to-peer mentoring in self managementAcquired Brain InjuryFamily CaregiversCaregiver stress and burden

Outcome Measures

Primary Outcomes (3)

  • 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.

    Attendance documented for all classes and meetings held during patients' inpatient stay; average inpatient length of stay is 52 days

  • Change in Kingston Caregiver Stress Scale (KCSS) scores

    Caregiver stress and burden; scores range from 10-50; higher score reflects higher stress

    1) baseline, at time of enrollment in the study; 2) within 72 hours of discharge to home; 3) 30-days post-discharge

  • Change in Patient Health Questionnaire - 9 (PHQ-9) scores

    Caregiver depressive symptoms; scores range from 0-27; higher score reflects higher depression

    1) baseline, at time of enrollment in the study; 2) within 72 hours of discharge to home; 3) 30-days post-discharge

Study Arms (2)

One-to-One Peer Mentoring

EXPERIMENTAL

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.

Behavioral: one-to-one peer mentoring

Usual Care

ACTIVE COMPARATOR

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.

Behavioral: one-to-one peer mentoring

Interventions

Weekly meetings with a peer family caregiver

One-to-One Peer MentoringUsual Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Discharge location is not home

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shepherd Center

Atlanta, Georgia, 30309, United States

Location

MeSH Terms

Conditions

Brain InjuriesCaregiver Burden

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesStress, PsychologicalBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director Emeritus, Virginia C Crawford Research Institute

Study Record Dates

First Submitted

April 8, 2021

First Posted

April 20, 2021

Study Start

January 8, 2019

Primary Completion

January 30, 2021

Study Completion

January 30, 2021

Last Updated

April 20, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations