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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-16

Study Completion Date

2025-10-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Trauma, Brain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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CG-Well

CG-Well is a web \& phone based psychosocial intervention that teaches caregivers how to obtain information, education \& support

Group Type EXPERIMENTAL

CG-Well

Intervention Type BEHAVIORAL

CG-Well is a web \& phone based psychosocial intervention that teaches caregivers how to obtain information, education \& support

Information Support and Referral

Attention control group that receives phone calls and modules from the Brain Injury Association of America.

Group Type PLACEBO_COMPARATOR

Information Support & Referral (ISR)

Intervention Type BEHAVIORAL

Attention control group that receives phone calls and modules from the Brain Injury Association of America.

Interventions

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CG-Well

CG-Well is a web \& phone based psychosocial intervention that teaches caregivers how to obtain information, education \& support

Intervention Type BEHAVIORAL

Information Support & Referral (ISR)

Attention control group that receives phone calls and modules from the Brain Injury Association of America.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes