ADPKD (autosomal Dominant Polycystic Kidney Disease)SDM-ADOPTNCT06618638
Shared Decision Making for Choosing Autosomal DOminant Polycystic Kidney Disease Treatment
A study testing Shared decision making model in people with ADPKD (autosomal Dominant Polycystic Kidney Disease), run by Seoul National University Hospital at 9 sites in South Korea.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- ADPKD (autosomal Dominant Polycystic Kidney Disease)
- What is being tested?
- Shared decision making model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 9 sitesSouth Korea
- Study dates
- 21 Oct 2024to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Participants who were previously exposured to tolvaptan
- Participants who are contraindicated to tolvaptan
- Participants who were judged ineligible by the investigator
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
South Korea9 sites, 9 recruiting
- Not yet recruiting
Hallym University Kangnam Sacred Heart Hospital
Anyang-si, Gyeonggi-do, 14068
Hayne Cho Park, +8210-2045-2513, loveyouseo@naver.com
+8210-5304-9728, hellocherry@hanmail.net
- Not yet recruiting
InjeUniversityBusanPaikHospital
Busan, 47392
Yeong Hoon Kim, +8251-890-8644, crc.yeoh@gmail.com
- Not yet recruiting
Keimyung University Dongsan Medical Center
Daegu, 42601
Seungyeup Han, +8210-5027-1250, kmudki@gmail.com
- Not yet recruiting
Chonnam National University Hospital
Gwangju, 61469
Eun Hui Bae, +8262-220-6292, dudduwnd@naver.com
+8210-5594-0851
- Recruiting
Seoul National University Hospital
Seoul, Republic of Korea, 03080
Jisun Chun, +82-2-2072-0335, adpkdsdm@gmail.com
- Not yet recruiting
Kangbuk Samsung Hospital
Seoul, 03181
Kyu-Beck Lee, +8210-9387-6074, hyun_0351.kim@samsung.com
- Not yet recruiting
Asan Medical Center
Seoul, 05505
Chung Hee Baek, +8210-2909-2523, kbyjh7@gmail.com
- Not yet recruiting
Seoul National University Boramae Hospital
Seoul, 07061
Yun Kyu Oh, +8210-2515-7485, jmp6036@naver.com
- Not yet recruiting
Korea University Guro Hospital
Seoul, 08308
Jieun Kim, +8210-4559-8359, nurse100337@gmail.com
About this study
Official title: Clinical Trial for Shared Decision Making Model for Choosing Pharmacotherapy in ADPKD Patients
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.
- Being tested
- Shared decision making model, Usual Care
- Keywords
- Autosomal Dominant Polycystic Kidney Disease, Shared Decision Making, Hybrid Randomized Controlled Trial type 1, Tolvaptan
- Medical subject headings
- Polycystic Kidney, Autosomal Dominant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shared decision making modelBehavioural
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.
Usual CareBehavioural
Usual care for ADPKD patients
| Study group | Role | What they receive |
|---|---|---|
| SDM group | Experimental | SDM group receives treatment using a shared decision-making model. Receives: Behavioral: Shared decision making model |
| Conventional group | Other | Conventional group receives treatment as usual. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in htTKV from baseline to 12 months
Calculate percent change in height adjusted total kidney volume (htTKV) from baseline to 12 months.
Measured: From enrollment to the end of treatment at 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start21 Oct 2024
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADPKD (autosomal Dominant Polycystic Kidney Disease)Studies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- 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
- Investigators
- Yong Chul Kim, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06618638
- Sponsor's protocol ID
- HV23C182600
- Acronym
- SDM-ADOPT
- Status last verified
- Nov 2024
- First submitted
- 26 Sep 2024
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial for Shared Decision Making Model for Choosing Pharmacotherapy in ADPKD Patients
- ClinicalTrials.gov ID
- NCT06618638
- Acronym / sponsor ID
- SDM-ADOPT / HV23C182600
- Keywords
- Autosomal Dominant Polycystic Kidney Disease, Shared Decision Making, Hybrid Randomized Controlled Trial type 1, Tolvaptan
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- 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
- Study start
- 21 Oct 2024 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SDM group | Experimental | Behavioral: Shared decision making modelSDM group receives treatment using a shared decision-making model. |
| Conventional group | Other | Behavioral: Usual CareConventional group receives treatment as usual. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Participants who were previously exposured to tolvaptan
- Participants who are contraindicated to tolvaptan
- Participants who were judged ineligible by the investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shared decision making modelShared 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. | Behavioural | SDM group |
| Usual CareUsual care for ADPKD patients | Behavioural | Conventional group |
Primary outcome
Percent change in htTKV from baseline to 12 months
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yong Chul Kim principal investigator
Seoul National University Hospital
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shared decision making model in people with ADPKD (autosomal Dominant Polycystic Kidney Disease), run by Seoul National University Hospital at 9 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jisun Chun (+82-2-2072-4072, adpkdsdm@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change in htTKV from baseline to 12 months (time frame: From enrollment to the end of treatment at 1 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2024.