Shared Decision Making for Choosing Autosomal DOminant Polycystic Kidney Disease Treatment
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSeoul National University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Participants who were previously exposured to tolvaptan
Participants who are contraindicated to tolvaptan
Participants who were judged ineligible by the investigator
Trial design
Design model
Parallel
Treatments tested in this trial
Shared decision making model
BehavioralShared 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
BehavioralUsual care for ADPKD patients
Treatment groups
340 Participants
are divided into 2 treatment groupsGroup A: SDM groupExperimental treatment 1 intervention
Group B: Conventional groupOther 1 intervention
Trial outcomes
Primary outcomes
1
Percent change in htTKV from baseline to 12 months
Calculate percent change in height adjusted total kidney volume (htTKV) from baseline to 12 months.
Time frame
From enrollment to the end of treatment at 1 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Seoul National University Hospital
Lead sponsor
Seoul National University
Collaborator
Hallym University Kangnam Sacred Heart Hospital
Collaborator
Kangbuk Samsung Hospital
Collaborator
Korea University Guro Hospital
Collaborator
Seoul National University Boramae Hospital
Collaborator
Asan Medical Center
Collaborator
InjeUniversityBusanPaikHospital
Collaborator
Chonnam National University Hospital
Collaborator
Keimyung University Dongsan Medical Center
Collaborator
Source ClinicalTrials.gov