Modular Scheduled Telephone Intervention for Caregivers of Persons With Traumatic Brain Injury: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 153
- 试验地点
- 2
- 主要终点
- Composite measure based on the Bakas Caregiving Outcomes Scale and the Brief Symptom Inventory
研究概览
简要总结
This study seeks to determine if problem-based telephone counseling improves quality of life and emotional well-being for caregivers of persons with moderate to severe traumatic brain injury (TBI).
详细描述
Caregivers and patients with TBI are recruited from the acute medical and inpatient rehabilitation units at Harborview Medical Center and the University of Washington Medical Center in Seattle, WA. After informed consent is obtained, information is gathered from the caregiver about his/her living situation, support systems, and the nature of the caregiving relationship. Additional information is gathered from the person with TBI about how he/she is doing cognitively, socially, and emotionally. Prior to discharge home, caregivers are randomly selected to receive either standard care (typical support and/or resources) or standard care plus problem-based telephone counseling.
The telephone follow-up group receives a telephone call from a caregiver support specialist at 2, 4, 6, 8, 10, 12, 14, and 16 weeks after discharge of the patient with TBI home with the option of two additional calls. During those calls, the caregiver support specialist provides training on problem-solving skills along with education on topics of interest to caregivers of persons with TBI.
An outcome assessment is done at 6 months and 1 year after discharge home.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Family member or other person having a long-term relationship (at least one year) with person with TBI admitted to hospital and discharged home from acute care, inpatient rehabilitation, and/or skilled nursing facility within 7 months of date of injury.
- •Sufficient English to permit communication without an interpreter.
排除标准
- •Lack of a telephone.
- •Lack of a permanent home address.
结局指标
主要结局
Composite measure based on the Bakas Caregiving Outcomes Scale and the Brief Symptom Inventory
时间窗: 6 mos and 1 year post discharge home
次要结局
- Brief Symptom Inventory (person with TBI)(6 mos post discharge home)
- Caregiver resource utilization(6 mos and 1 year post discharge home)
- Caregiver community participation as measured by the PART-O(6 mos and 1 year post discharge home)
- Caregiver employment(6 mos and 1 year post discharge home)
- Perceived Quality of Life (person with TBI)(6 mos post discharge home)
研究者
Janet Powell
Associate Professor
University of Washington