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Recruiting NCT06618638

Shared Decision Making for Choosing Autosomal DOminant Polycystic Kidney Disease Treatment

No phase Interventional ADPKD (autosomal Dominant Polycystic Kidney Disease)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Shared decision making model, Usual Care.
Who it may be relevant to
Registry conditions: ADPKD (autosomal Dominant Polycystic Kidney Disease). Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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.
  • Behavioral Usual Care
    Usual care for ADPKD patients

Primary outcome measures

  • Percent change in htTKV from baseline to 12 months [Time frame: From enrollment to the end of treatment at 1 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

South Korea · 9 centers
  • Hallym University Kangnam Sacred Heart Hospital — Anyang-si
  • Seoul National University Hospital — Seoul
  • InjeUniversityBusanPaikHospital — Busan
  • Keimyung University Dongsan Medical Center — Daegu
  • Chonnam National University Hospital — Gwangju
  • Kangbuk Samsung Hospital — Seoul
  • Asan Medical Center — Seoul
  • Seoul National University Boramae Hospital — Seoul
  • … and 1 more center

Identifiers

NCT: NCT06618638 · HV23C182600

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗