Clinical trial NCT05307640: Caregiver Wellness After Traumatic Brain Injury (CG-WELL): An Intervention Designed to Promote Well-being in Caregivers of Acute Moderate to Severe Traumatic Brain Injuries
Official title: Caregiver Wellness After Traumatic Brain Injury (CG-WELL): An Intervention Designed to Promote Well-being in Caregivers of Acute Moderate to Severe Traumatic Brain Injuries
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Trauma, Brain
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2022-04-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: After injury, survivors of msTBI depend on informal family caregivers. Upwards of 77% of family caregivers experience poor outcomes, such as adverse life changes, poor health related quality of life, and increased depressive symptoms. Caregivers frequently report minimal support or training to prepare them for their new role. Periods of care transitions, such as ICU discharge, are most difficult. The majority (93%) of previously developed caregiver and caregiver/survivor dyad interventions after msTBI focus on providing information or practical skills to either survivors, or to long-term caregivers (\>6 months post injury), rather than education, support, and skill-building that the new caregiver may use proactively that will benefit the dyad acutely after injury. The Aims of this proposal are to: (1) Determine feasibility, satisfaction, and data trends of CG-Well; and (2) Understand how baseline psychosocial risk factors affect response to CG-Well compared to an Information, Support, and Referral control group. To accomplish this, I will first enroll 6-10 caregivers and tailor CG-well until each finds the intervention acceptable, appropriate, and feasible. I will then enroll 100 (50/group) dyads and determine satisfaction ratings, recruitment, retention, and treatment fidelity of CG-Well. Additionally, I will determine if caregivers report reductions in depressive symptoms and improvements in life changes as a result of improvements in task difficulty and threat appraisal in CG-Well compared to ISR at six months. Information obtained in Aims 1 and 2 will be used to plan a larger Phase III trial of CG-Well. Completing these Aims and the training plan will improve outcomes of caregivers and downstream outcomes of survivors of msTBI, and provide me with the skillset necessary to become an independent researcher who can develop and test high-impact, high-fidelity, sustainable interventions.


Eligibility criteria: Inclusion criteria:

* Survivor and caregiver ≥18 years old
* Survivor GCS 3-12 after resuscitation
* Survivor \< 2 weeks post injury
* English Speaking - survivor and caregiver

Exclusion criteria:

* Patient not expected to survive.
* Pregnant - survivor or caregiver
* Prisoner - survivor or caregiver
* History of pre-existing condition that would interfere with follow-up in caregiver or survivor (e.g., substance abuse, alcoholism, end-stage cancers)
* Major prior debilitating neurological or mental health disorder in caregiver or survivor (e.g., schizophrenia, bipolar, stroke, dementia).

Primary outcomes:
measure: Intervention Satisfaction
timeFrame: 6 months
Secondary outcomes:
measure: Brief Symptom Inventory-18 (BSI-18)
timeFrame: 6 months
measure: Bakas Caregiver Outcomes Scale (BCOS)
timeFrame: 6 months
measure: Oberst Caregiving Burden Scale
timeFrame: 6 months
measure: Appraisal of Caregiving Scale Threat Subscale
timeFrame: 6 months
measure: Feasibility of CG-Well (Recruitment)
timeFrame: up to 30 months
measure: Feasibility of CG-Well (Retention)
timeFrame: 6 months
measure: Feasibility of CG-Well (Treatment Fidelity)
timeFrame: up to 36 months
measure: Feasibility of CG-Well (Number of Log Ins to the website)
timeFrame: up to 36 months
measure: Feasibility of CG-Well (Time that the participant spent in modules)
timeFrame: up to 36 months
measure: Feasibility of CG-Well (Time spent in monthly phone calls with the study team)
timeFrame: up to 36 months
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
Study officials:
References: