Clinical trial NCT06618638: Shared Decision Making for Choosing Autosomal DOminant Polycystic Kidney Disease Treatment
Official title: Clinical Trial for Shared Decision Making Model for Choosing Pharmacotherapy in ADPKD Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ADPKD (autosomal Dominant Polycystic Kidney Disease)
Keywords: Autosomal Dominant Polycystic Kidney Disease
Shared Decision Making
Hybrid Randomized Controlled Trial type 1
Tolvaptan
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Seoul National University
name: Hallym University Kangnam Sacred Heart Hospital
name: Kangbuk Samsung Hospital
name: Korea University Guro Hospital
name: Seoul National University Boramae Hospital
name: Asan Medical Center
name: InjeUniversityBusanPaikHospital
name: Chonnam National University Hospital
name: Keimyung University Dongsan Medical Center
First posted: 2024-10-01
Enrollment: 340
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percent change in htTKV from baseline to 12 months
timeFrame: From enrollment to the end of treatment at 1 months
Secondary outcomes:
Other outcomes:
Locations:
city: Anyang-si
country: Korea, Republic of
facility: Hallym University Kangnam Sacred Heart Hospital
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Republic of Korea
city: Busan
country: Korea, Republic of
facility: InjeUniversityBusanPaikHospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Boramae Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Yong Chul Kim
role: PRINCIPAL_INVESTIGATOR
References: