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NCT Number: NCT06618638

Shared Decision Making for Choosing Autosomal DOminant Polycystic Kidney Disease Treatment

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.

Recruiting

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hallym University Kangnam Sacred Heart Hospital, Anyang-si, Gyeonggi-do, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Shared decision making model

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.

Usual Care

Behavioral

Usual care for ADPKD patients

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jisun Chun

CONTACT

[email protected]

+82-2-2072-4072

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

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

Registry information

Official study title

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

Acronym: SDM-ADOPT

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 1, 2024
Registry last updated
Nov 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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