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Completed

NCT Number: NCT06126549

Comparison 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.

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Key information

Conditions

Acquired Brain Injury Behavior Behavioral Symptoms Brain Diseases Brain Injuries Caregiver Burden Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Stress, Psychological Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shepherd Center

Atlanta, Georgia, 30309, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Building Better Caregivers

Behavioral

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

Problem Solving Training

Behavioral

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

Usual Care

Behavioral

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

Primary outcomes

  1. Kingston Caregiver Stress Scale (KCSS)

    Time frame: 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

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

Secondary outcomes

  1. Patient Health Questionnaire - 9 (PHQ-9)

    Time frame: 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

    Caregiver depressive symptoms; scores range from 0-27; higher score reflects higher depression

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

    Time frame: 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

    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.

Other outcomes

  1. Patient unplanned hospital readmissions

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

    Hospital-wide assessment of number and duration of unplanned hospital readmissions in the 30 days post-discharge

Sponsors and collaborators

Lead sponsor

Shepherd Center, Atlanta GA

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 13, 2023
Registry last updated
Nov 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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