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

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.

Study Overview

• Status: Completed
• Conditions: Acquired Brain Injury
• Intervention / Treatment: Behavioral: Usual Care; Behavioral: Building Better Caregivers; Behavioral: Problem Solving Training

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.

• Study Type: Interventional
• Enrollment (Actual): 169
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Shepherd Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Patient's discharge location is not to home

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual Care; 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; Usual discharge training and support offered to family caregivers of ABI patients
Active Comparator: Building Better Caregivers; 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: Usual Care; Usual discharge training and support offered to family caregivers of ABI patients; Behavioral: Building Better Caregivers; Peer-led, group intervention for caregivers focused on problem-solving
Active Comparator: Problem Solving Training; 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: Usual Care; Usual discharge training and support offered to family caregivers of ABI patients; Behavioral: Problem Solving Training; Clinician-led, one-to-one intervention for caregivers focused on problem-solving

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Health Questionnaire - 9 (PHQ-9)	Caregiver depressive symptoms; scores range from 0-27; higher score reflects higher depression	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).	Contains 15 items within 3 subscales (self-efficacy for obtaining respite, responding to disruptive patient behaviors, and controlling upsetting thoughts about caregiving). Items are rated on a 0-100 scale.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient unplanned hospital readmissions	Hospital-wide assessment of number and duration of unplanned hospital readmissions in the 30 days post-discharge	Assessed by telephone follow-up interview 30-40 days post-discharge

Collaborators and Investigators

• Sponsor: Shepherd Center, Atlanta GA

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2021
• Primary Completion (Actual): December 15, 2022
• Study Completion (Actual): December 15, 2022

Study Registration Dates

• First Submitted: November 6, 2023
• First Submitted That Met QC Criteria: November 6, 2023
• First Posted (Actual): November 13, 2023

Study Record Updates

• Last Update Posted (Actual): November 15, 2023
• Last Update Submitted That Met QC Criteria: November 13, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Caregiver Stress; Family Caregivers; Caregiver Self-Efficacy; Acquired Brain Injury; Inpatient Rehabilitation
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries
• Other Study ID Numbers: 835

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No