NCT06618638

Shared Decision Making for Choosing Autosomal DOminant Polycystic Kidney Disease Treatment

Clinical Trial for Shared Decision Making Model for Choosing Pharmacotherapy in ADPKD Patients

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 340 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• ADPKD (autosomal Dominant Polycystic Kidney Disease)

Interventions

Type	Name	Description
BEHAVIORAL	Shared decision making model	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.
BEHAVIORAL	Usual Care	Usual care for ADPKD patients

Timeline

• Start date: 2024-10-21
• Primary completion: 2026-09-30
• Completion: 2026-09-30
• First posted: 2024-10-01
• Last updated: 2024-11-07

Locations

9 sites across 1 country: South Korea