Feasibility of Implementing Home Medication Review among End-Stage Renal Disease Patients in the Community-Setting in Udupi District: A Pharmacoeconomic Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- The primary outcome of the study is the assessment of reduction in the cost between pre and post intervention.
研究概览
简要总结
This study is conducted in 4 phases. Phase 1 focuses on systematically assessing the impact of HMR especially in dialysis patients through the scoping review. Phase 2 involves conducting the Qualitative Interviews to understand the perspectives of healthcare professionals and patients with respect to the cost associated with the dialysis, economic burden and other healthcare facilities available. In the next step, based on the findings from the literature review and interviews, an intervention will be developed and piloted in a small cohort of 12 patients. Following the pilot, outcomes will be evaluated to estimate the required sample size for the main study. The final phase will be implemented across two centers, starting with baseline assessments, followed by the intervention. Outcomes will be assessed at three time points—3, 6, and 12 months—focusing on reducing overall costs and economic burden, as well as improving quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •ESRD patients undergoing dialysis treatment for 2-3 sessions per week.
- •ESRD patients who are 18 years and above.
- •ESRD patients who are able to talk and give consent.
排除标准
- •The patients who are not undergoing dialysis treatment.
- •Pediatric ESRD patients ESRD patients who are bedridden.
- •ESRD patients who are paralyzed.
- •ESRD patients who are not willing to give consent due to other reasons.
- •The patients who are having cultural limitations.
结局指标
主要结局
The primary outcome of the study is the assessment of reduction in the cost between pre and post intervention.
时间窗: The patients will be followed-up in 4 time-points. Firstly, before providing the intervention and 3,6 and 12 months after providing the intervention.
次要结局
- The secondary outcome of the study is to assess the Quality of Life of the patients between pre and post intervention.(The patients will be followed-up in 4 time-points. Firstly, before providing the intervention and 3,6 and 12 months after providing the intervention.)
研究者
Sushanth K
Manipal College of Pharmaceutical Sciences