Comparison of Two Interventions for Caregivers of Patients With Acquired Brain Injury

NCT06126549 | Completed

• 1 other identifier: 835
• Study Type: interventional
• Target: 169
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare effectiveness of two interventions for family caregivers of patients with acquired brain injury who are transitioning home after inpatient rehabilitation. The main question it aims to answer is whether these interventions reduce caregiver stress and burden, compared to usual care. Secondary effects include the impact on caregivers' depressive symptoms and perceived self-efficacy as a caregiver. The study will also try to determine if caregivers will engage in these interventions during the acute (inpatient rehabilitation) stage of injury. Participants in the study are family members of the ABI patient, aged 18 year or older, who will be responsible for the patient's care and supervision once discharged home from inpatient rehabilitation. The two interventions, one clinician-led and one peer-led, will be compared to usual care.

Conditions

Acquired Brain Injury

Keywords

Acquired Brain Injury; Inpatient Rehabilitation; Family Caregivers; Caregiver Stress; Caregiver Self-Efficacy

Outcome Measures

Primary Outcomes (1)

• Kingston Caregiver Stress Scale (KCSS)

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

  1) baseline, at time of enrollment in the study and prior to randomization; 2) within 72 hours of discharge to home; 3) 30-days post-discharge; 90-days post-discharge

Secondary Outcomes (2)

• Patient Health Questionnaire - 9 (PHQ-9)

  1) baseline, at time of enrollment in the study and prior to randomization; 2) within 72 hours of discharge to home; 3) 30-days post-discharge; 90-days post-discharge

• Revised Scale for Caregiving Self-Efficacy (SCS-E).

  1) baseline, at time of enrollment in the study and prior to randomization; 2) within 72 hours of discharge to home; 3) 30-days post-discharge; 90-days post-discharge

Other Outcomes (1)

• Patient unplanned hospital readmissions

  Assessed by telephone follow-up interview 30-40 days post-discharge

Study Arms (3)

Usual Care

ACTIVE COMPARATOR

Usual Care (UC) consists of nurse instruction in care routines, case management family support for discharge, referral to family counseling and community services as indicated, and general information resources about brain injury. Usual Care participants also have access to peer support services, including peer mentoring, brain injury education classes, and workshops for caregivers.

Behavioral: Usual Care

Building Better Caregivers

ACTIVE COMPARATOR

Building Better Caregivers (BBC) was developed for caregivers of patients with Alzheimers' Disease and has been adapted for caregivers of patients with ABI. BBC is a peer-led, problem-solving intervention delivered in 6 group workshop sessions. Key components include problem-solving; making an action plan; managing stress and fatigue, difficult care partner behavior, and difficult thoughts/emotions. Each of the workshops last 60 minutes and usually take place once a week over a 6-8 week span of time.

Behavioral: Building Better Caregivers; Behavioral: Usual Care

Problem Solving Training

ACTIVE COMPARATOR

Problem Solving Training (PST) is a clinician-led intervention, administered one-on-one via phone calls, assigned readings, and practice assignments between calls. PST teaches caregivers how to address problems and apply a specific problem-solving technique that calls for brainstorming, consideration, development, and evaluation to address current problems the caregiver may be facing. The training aims to teach the strategy, so caregivers can apply it in the present, as well as the future. Each of the 6 Problem Solving Training Sessions last from 30-60 minutes and usually take place once a week over a 6-week span of time.

Behavioral: Problem Solving Training; Behavioral: Usual Care

Interventions

Building Better Caregivers BEHAVIORAL

Peer-led, group intervention for caregivers focused on problem-solving

Building Better Caregivers

Problem Solving Training BEHAVIORAL

Clinician-led, one-to-one intervention for caregivers focused on problem-solving

Problem Solving Training

Usual Care BEHAVIORAL

Usual discharge training and support offered to family caregivers of ABI patients

Building Better Caregivers; Problem Solving Training; Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Family member of patients admitted to inpatient rehabilitation for acquired brain injury, with a planned discharge to home.
• Able to begin intervention before discharge
• Able to speak and understand English or Spanish

You may not qualify if:

• Patient's discharge location is not to home

Sponsors & Collaborators

• Shepherd Center, Atlanta GA: lead

Study Sites (1)

Shepherd Center

Atlanta, Georgia, 30309, United States

Location

MeSH Terms

Conditions

Brain Injuries; Caregiver Burden

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Stress, Psychological; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Emeritus, Virginia C Crawford Research Institute

Model Details: Evaluation of two interventions to usual care, comparing change over time in three outcome measures: caregiver stress, caregiver depression, caregiver perceived self-efficacy in care management

Study Record Dates

• First Submitted: November 6, 2023
• First Posted: November 13, 2023
• Study Start: February 16, 2021
• Primary Completion: December 15, 2022
• Study Completion: December 15, 2022
• Last Updated: November 15, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)