Shared Decision Making for Choosing Autosomal DOminant Polycystic Kidney Disease Treatment (SDM-ADOPT)

Seoul National University

Status: Enrolling

Conditions: ADPKD (autosomal Dominant Polycystic Kidney Disease)

Treatments: Behavioral: Usual Care; Behavioral: Shared decision making model

Study type: Interventional

Funder types: Other

Identifiers

NCT06618638

HV23C182600

Details and patient eligibility

About

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.

Full 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.

Enrollment: 340 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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340 participants in 2 patient groups

SDM group

Experimental group

Description:

SDM group receives treatment using a shared decision-making model.

Treatment:

Behavioral: Shared decision making model

Conventional group

Other group

Description:

Conventional group receives treatment as usual.

Treatment:

Behavioral: Usual Care