Shared Decision Making for Choosing Autosomal DOminant Polycystic Kidney Disease Treatment

Not Applicable

Recruiting

• Conditions: ADPKD (autosomal Dominant Polycystic Kidney Disease)
• Interventions: Behavioral: Shared decision making model; Behavioral: Usual Care

• Registration Number: NCT06618638
• Lead Sponsor: Seoul National University Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2024-09-26
• Study First Submitted QC: 2024-09-26
• Study First Posted: 2024-10-01
• Study Start: 2024-10-21
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-05
• Last Update Posted: 2024-11-07
• Primary Completion: 2026-09-30
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 340

Inclusion Criteria

• 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

Exclusion Criteria

• Participants who were previously exposured to tolvaptan
• Participants who are contraindicated to tolvaptan
• Participants who were judged ineligible by the investigator

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SDM group	Shared decision making model	-
Conventional group	Usual Care	-

Primary Outcome Measures

Name	Time	Method
Percent change in htTKV from baseline to 12 months	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.

Trial Locations

Locations (9)

Hallym University Kangnam Sacred Heart Hospital; 🇰🇷 Anyang-si, Gyeonggi-do, Korea, Republic of

InjeUniversityBusanPaikHospital; 🇰🇷 Busan, Korea, Republic of

Keimyung University Dongsan Medical Center; 🇰🇷 Daegu, Korea, Republic of

Chonnam National University Hospital; 🇰🇷 Gwangju, Korea, Republic of

Kangbuk Samsung Hospital; 🇰🇷 Seoul, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Boramae Hospital; 🇰🇷 Seoul, Korea, Republic of

Korea University Guro Hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Republic of Korea, Korea, Republic of