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 (CG-Well)

Natalie Kreitzer

Status: Enrolling

Conditions: Trauma, Brain

Treatments: Behavioral: Information Support & Referral (ISR); Behavioral: CG-Well

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05307640

2020-1198 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

CG-Well

Experimental group

Description:

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

Treatment:

Behavioral: CG-Well

Information Support and Referral

Placebo Comparator group

Description:

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

Treatment:

Behavioral: Information Support & Referral (ISR)