Clinical Trial for Shared Decision Making Model for Choosing Pharmacotherapy in ADPKD Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 340
- 试验地点
- 18
- 主要终点
- Percent change in htTKV from baseline to 12 months
研究概览
简要总结
The purpose of this study is to generate clinical evidence and assess the feasibility of a shared decision-making (SDM) model for the selection of Tolvaptan in patients with ADPKD.
详细描述
Autosomal dominant polycystic kidney disease (ADPKD) patients, eligible to taking tolvaptan, have to decide whether to take tolvaptan regarding critical factors such as water intake, side effects, and their personal values and preferences. Our study aims to develop and validate a shared decision-making (SDM) model for ADPKD patients considering tolvaptan therapy.
The SDM model we developed include a patient decision aid, educational materials and self-monitoring tools, all provided by a mobile application. This model was built to deliver enough knowledge and considerations during a decision-making process, which would be helpful for patients to reach a decision on tolvaptan.
Through the multi-center hybrid randomized controlled trial, the model's effectiveness and feasibility will be evaluated. Improvements in treatment outcomes, patient satisfaction, adherence, and quality of life are anticipated. This study can propose a structured, patient-centered framework for therapeutic decision-making in ADPKD patients.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants between the age of 18 to 80
- •Participants with a diagnosis with CKD stage 2 or 3
- •Participants with a diagnosis with ADPKD classified as 1C, 1D, or 1E according to Mayo classification
- •Participants with the ability to communicate and use digital devices
- •Participants with no severe visual impairment and cognitive dysfunction
排除标准
- •Participants who were previously exposured to tolvaptan
- •Participants who are contraindicated to tolvaptan
- •Participants who were judged ineligible by the investigator
结局指标
主要结局
Percent change in htTKV from baseline to 12 months
时间窗: From enrollment to the end of treatment at 1 months
Calculate percent change in height adjusted total kidney volume (htTKV) from baseline to 12 months.
次要结局
未报告次要终点