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RecruitingNCT06618638SDM-ADOPTUpdated Nov 7, 2024

Shared Decision Making for Choosing Autosomal DOminant Polycystic Kidney Disease Treatment

An interventional study of Shared decision making model and Usual Care in ADPKD (autosomal Dominant Polycystic Kidney Disease), sponsored by Seoul National University Hospital. Recruiting at 9 sites in Korea, Republic of. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-11-07.

Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2024; still recruiting 2 years later.

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Phase
Not applicable
Study type
Interventional
Enrollment
340
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • ADPKD (autosomal Dominant Polycystic Kidney Disease)

Keywords

  • Autosomal Dominant Polycystic Kidney Disease
  • Shared Decision Making
  • Hybrid Randomized Controlled Trial type 1
  • Tolvaptan
03

In context

Polycystic Kidney, Autosomal Dominant

185 studies on the registry are indexed under Polycystic Kidney, Autosomal Dominant; 42 are open to participants now.

This study's planned enrollment of 340 is above the median of 51 across 138 interventional studies indexed under Polycystic Kidney, Autosomal Dominant.

Browse Polycystic Kidney, Autosomal Dominant studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,900 studies on the registry; 274 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Browse Seoul National University Hospital studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Participants who were previously exposured to tolvaptan
  • Participants who are to tolvaptan
  • Participants who were judged ineligible by the investigator
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
340 participants (estimated)

Study arms

  • Experimental
    SDM group

    SDM group receives treatment using a shared decision-making model.

    Behavioral: Shared decision making model

  • Other
    Conventional group

    Conventional group receives treatment as usual.

    Behavioral: Usual Care

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

06

What researchers measure

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 months

07

Study locations

1 of 9 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2024 (actual). Primary completion is estimated for Sep 2026, 23 months after the start.

Of 23 interventional studies with no phase under Polycystic Kidney, Autosomal Dominant, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 54. This study's planned 23 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 26, 2024
First posted
Oct 1, 2024
StartActual
Oct 21, 2024
Primary completionEst.
Sep 30, 2026
CompletionEst.
Sep 30, 2026
Last update
Nov 7, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 7, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06618638
Lead sponsor
Seoul National University Hospital
Collaborators
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
Responsible party
Sponsor
First posted
Oct 1, 2024
Start date
Oct 21, 2024
Primary completion
Sep 30, 2026 (estimated)
Completion
Sep 30, 2026 (estimated)
Last update
Nov 7, 2024

Study contacts

Jisun Chun
Contact
adpkdsdm@gmail.com
+82-2-2072-4072
Yong Chul Kim
principal investigator · Seoul National University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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