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

November 5, 2024 updated by: Seoul National University Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

340

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of, 47392
        • Not yet recruiting
        • InjeUniversityBusanPaikHospital
        • Contact:
      • Daegu, Korea, Republic of, 42601
        • Not yet recruiting
        • Keimyung University Dongsan Medical Center
        • Contact:
      • Gwangju, Korea, Republic of, 61469
        • Not yet recruiting
        • Chonnam National University Hospital
        • Contact:
        • Contact:
          • Phone Number: +8210-5594-0851
      • Seoul, Korea, Republic of, 05505
        • Not yet recruiting
        • Asan Medical Center
        • Contact:
      • Seoul, Korea, Republic of, 03181
        • Not yet recruiting
        • Kangbuk Samsung Hospital
        • Contact:
      • Seoul, Korea, Republic of, 08308
        • Not yet recruiting
        • Korea University Guro Hospital
        • Contact:
      • Seoul, Korea, Republic of, 07061
        • Not yet recruiting
        • Seoul National University Boramae Hospital
        • Contact:
    • Gyeonggi-do
      • Anyang-si, Gyeonggi-do, Korea, Republic of, 14068
        • Not yet recruiting
        • Hallym University Kangnam Sacred Heart Hospital
        • Contact:
        • Contact:
    • Republic of Korea
      • Seoul, Republic of Korea, Korea, Republic of, 03080
        • Recruiting
        • Seoul National University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SDM group
SDM group receives treatment using a shared decision-making model.
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.
Other: Conventional group
Conventional group receives treatment as usual.
Behavioral: Usual Care
Usual care for ADPKD patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent change in htTKV from baseline to 12 months
Time Frame: 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.
From enrollment to the end of treatment at 1 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Asan Medical Center
Chonnam National University Hospital
Korea University Guro Hospital
Seoul National University
Seoul National University Boramae Hospital
Kangbuk Samsung Hospital
Keimyung University Dongsan Medical Center
Hallym University Kangnam Sacred Heart Hospital
InjeUniversityBusanPaikHospital

Investigators

  • Principal Investigator: Yong Chul Kim, Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 21, 2024

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

September 26, 2024

First Submitted That Met QC Criteria

September 26, 2024

First Posted (Actual)

October 1, 2024

Study Record Updates

Last Update Posted (Estimated)

November 7, 2024

Last Update Submitted That Met QC Criteria

November 5, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HV23C182600

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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