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临床试验/NCT05307640
NCT05307640招募中不适用

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

Natalie Kreitzer2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年8月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
2
主要终点
Intervention Satisfaction

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

CG-Well

Experimental

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

干预措施: CG-Well (Behavioral)

Information Support and Referral

Placebo Comparator

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

干预措施: Information Support & Referral (ISR) (Behavioral)

结局指标

主要结局

Intervention Satisfaction

时间窗: 6 months

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)

次要结局

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

研究者

发起方
Natalie Kreitzer
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Natalie Kreitzer

Associate Professor Emergency Medicine

University of Cincinnati

研究点 (2)

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