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

Acquired Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06126549
• Other study ID #: 835
• Status: Completed
• Phase: N/A
• Start date: February 16, 2021
• Est. completion date: December 15, 2022

Study information

• Verified date: November 2023
• Source: Shepherd Center, Atlanta GA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 169
• Est. completion date: December 15, 2022
• Est. primary completion date: December 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Brain Injury
• Brain Injuries
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
United States	Shepherd Center	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Shepherd Center, Atlanta GA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	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