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

NCT05307640 | Recruiting DMC

• 1 other identifier: 2020-1198
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Trauma, Brain

Outcome Measures

Primary Outcomes (1)

• Intervention Satisfaction

  Scale Title: Caregiver Intervention Satisfaction Scale. Likert's scale of usability, ease of use, and acceptability of INR or CG-Well A higher score indicates greater satisfaction; 1-5 scale (strongly disagree=1; strongly agree=5)

  6 months

Secondary Outcomes (10)

• Brief Symptom Inventory-18 (BSI-18)

  6 months

• Bakas Caregiver Outcomes Scale (BCOS)

  6 months

• Oberst Caregiving Burden Scale

  6 months

• Appraisal of Caregiving Scale Threat Subscale

  6 months

• Feasibility of CG-Well (Recruitment)

  up to 30 months

Study Arms (2)

CG-Well

EXPERIMENTAL

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

Behavioral: CG-Well

Information Support and Referral

PLACEBO COMPARATOR

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

Behavioral: Information Support & Referral (ISR)

Interventions

CG-Well BEHAVIORAL

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

CG-Well

Information Support & Referral (ISR) BEHAVIORAL

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

Information Support and Referral

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Natalie Kreitzer: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45267, United States

RECRUITING

Related Publications (1)

• Kreitzer N, Fink S, Adeoye O, Kurowski G B, Wade S, Sucharew H, Bakas T. Caregiver Wellness after Traumatic Brain Injury (CG-Well): Protocol for a randomized clinical trial. Contemp Clin Trials Commun. 2024 Aug 24;41:101356. doi: 10.1016/j.conctc.2024.101356. eCollection 2024 Oct.

  PMID: 39280784 DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Referral and Consultation

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Professional Practice; Organization and Administration; Health Services Administration

Central Study Contacts

Emily Werff

CONTACT

513-307-2963; werffel@ucmail.uc.edu

Stephanie Thomas

CONTACT

513-315-4001; notlins@ucmail.uc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor Emergency Medicine

Study Record Dates

• First Submitted: March 14, 2022
• First Posted: April 1, 2022
• Study Start: August 16, 2021
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: March 26, 2025

Record last verified: 2025-03

Locations

US (1)