Acquired Brain InjuryNCT06126549
Comparison of Two Interventions for Caregivers of Patients With Acquired Brain Injury
A study testing Building Better Caregivers and Problem Solving Training in people with Acquired Brain Injury, run by Shepherd Center, Atlanta GA at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acquired Brain Injury
- What is being tested?
- Building Better Caregivers and Problem Solving Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 169 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Feb 2021to 15 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patient's discharge location is not to home
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Building Better Caregivers, Problem Solving Training, Usual Care
- Keywords
- Acquired Brain Injury, Inpatient Rehabilitation, Family Caregivers, Caregiver Stress, Caregiver Self-Efficacy
- Medical subject headings
- Brain Injuries, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Building Better CaregiversBehavioural
Peer-led, group intervention for caregivers focused on problem-solving
Problem Solving TrainingBehavioural
Clinician-led, one-to-one intervention for caregivers focused on problem-solving
Usual CareBehavioural
Usual discharge training and support offered to family caregivers of ABI patients
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | 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. Receives: Behavioral: Usual Care |
| Building Better Caregivers | Active comparator | 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. Receives: Behavioral: Building Better Caregivers; Behavioral: Usual Care |
| Problem Solving Training | Active comparator | 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. Receives: Behavioral: Problem Solving Training; Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kingston Caregiver Stress Scale (KCSS)
Caregiver stress and burden; scores range from 10-50; higher score reflects higher stress
Measured: 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 (2)
Patient Health Questionnaire - 9 (PHQ-9)
Caregiver depressive symptoms; scores range from 0-27; higher score reflects higher depression
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start16 Feb 2021
- Primary completion15 Dec 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- None (open label)
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shepherd Center, Atlanta GA
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Jones, Shepherd Center, Atlanta GA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06126549
- Sponsor's protocol ID
- 835
- Status last verified
- Nov 2023
- First submitted
- 6 Nov 2023
- Last updated
- 15 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial to Compare Effectiveness of Two Interventions for Caregivers of Patients With Acquired Brain Injury
- ClinicalTrials.gov ID
- NCT06126549
- Acronym / sponsor ID
- 835
- Conditions
- Acquired Brain Injury
- Keywords
- Acquired Brain Injury, Inpatient Rehabilitation, Family Caregivers, Caregiver Stress, Caregiver Self-Efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- Shepherd Center, Atlanta GAUniversity, hospital or other
- Study start
- 16 Feb 2021 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Behavioral: Usual CareUsual 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. |
| Building Better Caregivers | Active comparator | Behavioral: Building Better Caregivers, Behavioral: Usual CareBuilding 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. |
| Problem Solving Training | Active comparator | Behavioral: Problem Solving Training, Behavioral: Usual CareProblem 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Patient's discharge location is not to home
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Building Better CaregiversPeer-led, group intervention for caregivers focused on problem-solving | Behavioural | Building Better Caregivers |
| Problem Solving TrainingClinician-led, one-to-one intervention for caregivers focused on problem-solving | Behavioural | Problem Solving Training |
| Usual CareUsual discharge training and support offered to family caregivers of ABI patients | Behavioural | Building Better Caregivers, Problem Solving Training, Usual Care |
Primary outcome
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
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Building Better Caregivers and Problem Solving Training in people with Acquired Brain Injury, run by Shepherd Center, Atlanta GA at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2023.