Decision-making support for choosing treatment in kidney disease
Clinical Trial for Shared Decision Making Model for Choosing Pharmacotherapy in ADPKD Patients
This study is testing a new mobile app that helps patients with a specific type of kidney disease make better treatment choices about a medication called tolvaptan.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 340 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Seoul National University Hospital Academic / other |
| Locations | 9 sites (Anyang-si, Gyeonggi-do and 8 other locations) |
| Trial ID | NCT06618638 on ClinicalTrials.gov |
What this trial studies
This study aims to develop and validate a shared decision-making (SDM) model for patients with autosomal dominant polycystic kidney disease (ADPKD) who are considering treatment with tolvaptan. The SDM model includes a patient decision aid, educational materials, and self-monitoring tools delivered through a mobile application. By evaluating the model's effectiveness and feasibility in a multi-center hybrid randomized controlled trial, the study seeks to improve treatment outcomes, patient satisfaction, adherence, and quality of life for participants. The approach emphasizes patient-centered decision-making based on individual values and preferences.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 80 with a diagnosis of ADPKD classified as 1C, 1D, or 1E and chronic kidney disease (CKD) stage 2 or 3.
Not a fit: Patients who have previously been exposed to tolvaptan or are contraindicated to its use will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could empower patients with ADPKD to make informed treatment decisions that align with their personal values and improve their overall health outcomes.
How similar studies have performed: Other studies have shown success with shared decision-making approaches in chronic disease management, indicating potential for this model to be effective as well.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Anyang-si, Gyeonggi-do and 8 other locations
- Hallym University Kangnam Sacred Heart Hospital — Anyang-si, Gyeonggi-do, South Korea (Not_yet_recruiting)
- Seoul National University Hospital — Seoul, Republic of Korea, South Korea (Recruiting)
- InjeUniversityBusanPaikHospital — Busan, South Korea (Not_yet_recruiting)
- Keimyung University Dongsan Medical Center — Daegu, South Korea (Not_yet_recruiting)
- Chonnam National University Hospital — Gwangju, South Korea (Not_yet_recruiting)
- Kangbuk Samsung Hospital — Seoul, South Korea (Not_yet_recruiting)
- Asan Medical Center — Seoul, South Korea (Not_yet_recruiting)
- Seoul National University Boramae Hospital — Seoul, South Korea (Not_yet_recruiting)
- Korea University Guro Hospital — Seoul, South Korea (Not_yet_recruiting)
Study contacts
- Principal investigator: Yong Chul Kim — Seoul National University Hospital
- Study coordinator: Jisun Chun
- Email: adpkdsdm@gmail.com
- Phone: +82-2-2072-4072
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.