ADPKD (autosomal Dominant Polycystic Kidney Disease)
Conditions
Keywords
Autosomal Dominant Polycystic Kidney Disease, Shared Decision Making, Hybrid Randomized Controlled Trial type 1, Tolvaptan
Brief summary
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
BEHAVIORALShared 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.
BEHAVIORALUsual Care
Usual care for ADPKD patients
Sponsors
Seoul National University
Hallym University Kangnam Sacred Heart Hospital
Kangbuk Samsung Hospital
Korea University Guro Hospital
Seoul National University Boramae Hospital
Asan Medical Center
InjeUniversityBusanPaikHospital
Chonnam National University Hospital
Keimyung University Dongsan Medical Center
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent change in htTKV from baseline to 12 months | 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. |
Countries
South Korea
Contacts
Primary ContactJisun Chun
Outcome results
None listed