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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
340
Shared decision making model for choosing pharmacotherapy in ADPKD patients. This newly developed shared decision making model follows the SHARE approach and includes patient education, identifying values and preferences, reaching a decision and evaluating.
Usual care for ADPKD patients
Hallym University Kangnam Sacred Heart Hospital
Anyang-si, Gyeonggi-do, South Korea
NOT_YET_RECRUITINGSeoul National University Hospital
Seoul, Republic of Korea, South Korea
RECRUITINGInjeUniversityBusanPaikHospital
Percent change in htTKV from baseline to 12 months
Calculate percent change in height adjusted total kidney volume (htTKV) from baseline to 12 months.
Time frame: From enrollment to the end of treatment at 1 months
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Busan, South Korea
Keimyung University Dongsan Medical Center
Daegu, South Korea
NOT_YET_RECRUITINGChonnam National University Hospital
Gwangju, South Korea
NOT_YET_RECRUITINGKangbuk Samsung Hospital
Seoul, South Korea
NOT_YET_RECRUITINGAsan Medical Center
Seoul, South Korea
NOT_YET_RECRUITINGSeoul National University Boramae Hospital
Seoul, South Korea
NOT_YET_RECRUITINGKorea University Guro Hospital
Seoul, South Korea
NOT_YET_RECRUITING