Technology Assisted Stepped Collaborative Care Intervention (TASCCI) to Improve Patient-centered Outcomes in Hemodialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Change in pain from baseline to 12 weeks
研究概览
简要总结
This study evaluates a collaborative care intervention in reducing depression, fatigue and pain symptoms and improving health related quality of life in hemodialysis patients. Half of participants will receive the collaborative care intervention, while the other half will receive technology delivered health education information.
详细描述
End-stage renal disease patients on hemodialysis experience substantial symptom burden with fatigue, pain and depression among the most debilitating and existing as symptom clusters. These symptom clusters can exacerbate one another, and are independent and strong predictors of poor health-related quality of life in hemodialysis patients. This study will look at the effect of a 12 week stepped care intervention on changes in depression, pain or fatigue and health related quality of life.
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)
盲法说明
Patient reported outcomes will be administered centrally by blinded interviewers using computer-assisted telephone interviewing (CATI).
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
- •18 years or older
- •undergoing thrice-weekly maintenance hemodialysis for > 3 months
- •English speaking
- •able to provide informed consent
- •no evidence of thought disorder, delusions or active suicidal ideation
排除标准
- •thought disorder, delusions or active suicidal ideation
- •active substance abuse
- •too ill or cognitively impaired to participate based on clinicians' judgment
- •anticipated life expectancy of less than 1 year
- •unable or unwilling to adhere to study protocol
- •participating in another clinical trial or taking an investigational drug
- •scheduled for living donor kidney transplant within next 6 months
- •relocating to another dialysis unit within 6 months
结局指标
主要结局
Change in pain from baseline to 12 weeks
时间窗: Baseline and Post 12 week intervention
Pain symptoms will be measured using the Brief Pain Inventory
Change in fatigue from baseline to 12 weeks
时间窗: Baseline and Post 12 week intervention
Fatigue symptoms will be measured using the FACIT-F
Change in depression from baseline to 12 weeks
时间窗: Baseline and Post 12 week intervention
Depressive symptoms will be measured using the Beck Depression Inventory-II
次要结局
- Change in adherence to hemodialysis treatments(Baseline and Post 12 week intervention)
- Change in adherence to medications(Baseline, 3 month, 6 month, 12 month)
- Change in adherence to fluid restriction(Baseline, 3 month, 6 month, 12 month)
研究者
Manisha Jhamb
Associate Professor of Medicine
University of Pittsburgh