Clinical trial NCT06126549: Comparison of Two Interventions for Caregivers of Patients With Acquired Brain Injury
Official title: A Randomized Trial to Compare Effectiveness of Two Interventions for Caregivers of Patients With Acquired Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acquired Brain Injury
Keywords: Acquired Brain Injury
Inpatient Rehabilitation
Family Caregivers
Caregiver Stress
Caregiver Self-Efficacy
Lead sponsor: Shepherd Center, Atlanta GA
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 169
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Kingston Caregiver Stress Scale (KCSS)
timeFrame: 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:
measure: Patient Health Questionnaire - 9 (PHQ-9)
timeFrame: 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
measure: Revised Scale for Caregiving Self-Efficacy (SCS-E).
timeFrame: 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:
measure: Patient unplanned hospital readmissions
timeFrame: Assessed by telephone follow-up interview 30-40 days post-discharge
Locations:
city: Atlanta
country: United States
facility: Shepherd Center
state: Georgia
Study officials:
References: