Shared Decision Making for Choosing Autosomal DOminant Polycystic Kidney Disease Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

340 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-21

Study Completion Date

2026-09-30

Brief Summary

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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.

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Detailed Description

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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

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ADPKD (autosomal Dominant Polycystic Kidney Disease)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SDM group

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

Group Type EXPERIMENTAL

Shared decision making model

Intervention Type BEHAVIORAL

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.

Conventional group

Conventional group receives treatment as usual.

Group Type OTHER

Usual Care

Intervention Type BEHAVIORAL

Usual care for ADPKD patients

Interventions

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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.

Intervention Type BEHAVIORAL

Usual Care

Usual care for ADPKD patients

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yong Chul Kim

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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