CAREGIVER: An Randomized Clinical Trial (RCT) to Improve the Burden and Distress of Caring for Persons With Decompensated Cirrhosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 2
- 主要终点
- Change in burden of caregivers measured using the Zarit Burden Interview (ZBI -12)
研究概览
简要总结
The goal of this study is to enroll caretakers of patients with decompensated cirrhosis to determine if written emotional disclosure or resilience training interventions reduce distress and burden among primary informal caregivers.
Caretakers that meet eligibility will complete baseline assessments in person, or if necessary, over the phone and be randomized to be in one of three arms of this study. Materials specific to each study arm will be mailed to the caretakers home along with instructions. Overall, the study will take approximately 2 months and a qualitative interview will also be completed around 3-6 months post-baseline.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary informal caregiver for a patient with a clinical diagnosis of decompensated cirrhosis with either of the following three clinical criteria:
- •Child-Turcotte Pugh (CTP) Class A/B/C cirrhosis with an all cause hospitalization within the previous 30 days.
- •CTP Class B or C cirrhosis with one of the following within the prior 6 months from the date of enrollment:
- •Ascites (requiring paracentesis or diuretics)
- •Overt Hepatic Encephalopathy (requiring lactulose or rifaximin/flagyl/neomycin)
- •Spontaneous Bacterial Peritonitis (SBP)
- •Hepatic Hydrothorax (requiring diuretics or thoracentesis)
- •Variceal Bleed (with 1 or more recurrences)
- •Hepatocellular Carcinoma (HCC)
- •Any Barcelona Clinic Liver Cancer (BCLC) Stage with CTP Class B or C
- •BCLC Stage C or D with CTP Class A
排除标准
- •Non-English speaking
- •Unable or unwilling to provide verbal consent
- •Severe cognitive impairment
- •Caregiver is participating in another interventional study
- •Caregiver has used a personal diary within the past 12 months
结局指标
主要结局
Change in burden of caregivers measured using the Zarit Burden Interview (ZBI -12)
时间窗: At baseline and then at 4 week and 8 weeks
The short form of the ZBI is a validated short 12-item questionnaire measuring perceived burden associated with care giving. Participants rate each item on a 5-point scale ranging from 0 (never) to 4 (nearly always) the range of possible score is 0 (less burden) to 48 (more burden).
次要结局
- Change in Distress Thermometer (DT)(At baseline and then at 4 week and 8 weeks)
- Change in Visual Analogue Score (VAS)(At baseline and then at 4 week and 8 weeks)
- Change in Caregiver Captivity Index (CCI)(At baseline and then at 4 week and 8 weeks)
研究者
Elliot B. Tapper
Assistant Professor of Internal Medicine
University of Michigan