NCT06126549

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

A Randomized Trial to Compare Effectiveness of Two Interventions for Caregivers of Patients With Acquired Brain Injury

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 169 (actual)
• Sponsor: Shepherd Center, Atlanta GA · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study will evaluate effectiveness of two problem-solving training interventions on caregivers' emotional health and well-being (stress, depressive symptoms, caregiving self-efficacy). Participants are family members of patients with acquired brain injuries (ABI) admitted for inpatient rehabilitation, with a planned discharge home. Caregivers who agree to participate will be randomly assigned to one of three family support interventions. The Building Better Caregiver program is a peer-led group intervention. Problem Solving Training is an individual clinician-led intervention. Both interventions aim to equip caregivers with problem solving tools. The third intervention is existing support and assistance for family members who will be caregivers for patients discharged home after inpatient rehabilitation. This Usual Care is available to all three groups and 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. Caregiver-reported outcome measures (CROs) will be collected in three domains: 1) caregiver stress/burden and emotional health, 2) caregiver perceived self-efficacy in managing their loved-one's care needs, and 3) healthcare utilization by patient and caregiver. We will use three standardized outcome measures: 1) Kingston Caregiver Stress Scale (KCSS), 2) Patient Health Questionnaire (PHQ-9), and 3) Revised Scale for Caregiving Self-Efficacy (SCS-E). The measures will be collected at four timepoints: upon enrollment in the study ("Pre"), within 72 hours of discharge (D/C), and 30 and 90 days post-discharge. The impact of each intervention on the rate of patients' 30-day, unplanned hospital readmissions will also be examined.

Conditions

• Acquired Brain Injury

Interventions

Type	Name	Description
BEHAVIORAL	Building Better Caregivers	Peer-led, group intervention for caregivers focused on problem-solving
BEHAVIORAL	Problem Solving Training	Clinician-led, one-to-one intervention for caregivers focused on problem-solving
BEHAVIORAL	Usual Care	Usual discharge training and support offered to family caregivers of ABI patients

Timeline

• Start date: 2021-02-16
• Primary completion: 2022-12-15
• Completion: 2022-12-15
• First posted: 2023-11-13
• Last updated: 2023-11-15

Locations

1 site across 1 country: United States