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

Обзор

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.

Вмешательства

• Поведенческое CG-Well
  CG-Well is a web \& phone based psychosocial intervention that teaches caregivers how to obtain information, education \& support
• Поведенческое Information Support & Referral (ISR)
  Attention control group that receives phone calls and modules from the Brain Injury Association of America.

Первичные конечные точки

• Intervention Satisfaction [Срок оценки: 6 months]

Вторичные конечные точки (10)

• Brief Symptom Inventory-18 (BSI-18) [Срок оценки: 6 months]
• Bakas Caregiver Outcomes Scale (BCOS) [Срок оценки: 6 months]
• Oberst Caregiving Burden Scale [Срок оценки: 6 months]
• Appraisal of Caregiving Scale Threat Subscale [Срок оценки: 6 months]
• Feasibility of CG-Well (Recruitment) [Срок оценки: up to 30 months]
• Feasibility of CG-Well (Retention) [Срок оценки: 6 months]
• Feasibility of CG-Well (Treatment Fidelity) [Срок оценки: up to 36 months]
• Feasibility of CG-Well (Number of Log Ins to the website) [Срок оценки: up to 36 months]
• Feasibility of CG-Well (Time that the participant spent in modules) [Срок оценки: up to 36 months]
• Feasibility of CG-Well (Time spent in monthly phone calls with the study team) [Срок оценки: up to 36 months]

Критерии участия

Критерии включения

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

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Организация здравоохранения

Центры проведения

США · 1 центр

• University of Cincinnati — Cincinnati

Публикации

• 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

Идентификаторы

NCT: NCT05307640 · 2020-1198

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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