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| Name | Class |
|---|---|
| Seoul National University | OTHER |
| Hallym University Kangnam Sacred Heart Hospital | OTHER |
| Kangbuk Samsung Hospital | OTHER |
| Korea University Guro Hospital |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SDM group | Experimental | SDM group receives treatment using a shared decision-making model. |
|
| Conventional group | Other | Conventional group receives treatment as usual. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shared decision making model | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change in htTKV from baseline to 12 months | Calculate percent change in height adjusted total kidney volume (htTKV) from baseline to 12 months. | From enrollment to the end of treatment at 1 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jisun Chun | Contact | +82-2-2072-4072 | adpkdsdm@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Yong Chul Kim | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hallym University Kangnam Sacred Heart Hospital | Not yet recruiting | Anyang-si | Gyeonggi-do | 14068 | South Korea |
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| OTHER |
| Seoul National University Boramae Hospital | OTHER |
| Asan Medical Center | OTHER |
| InjeUniversityBusanPaikHospital | UNKNOWN |
| Chonnam National University Hospital | OTHER |
| Keimyung University Dongsan Medical Center | OTHER |
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|
| Usual Care | Behavioral | Usual care for ADPKD patients |
|
| Seoul National University Hospital | Recruiting | Seoul | Republic of Korea | 03080 | South Korea |
|
| InjeUniversityBusanPaikHospital | Not yet recruiting | Busan | 47392 | South Korea |
|
| Keimyung University Dongsan Medical Center | Not yet recruiting | Daegu | 42601 | South Korea |
|
| Chonnam National University Hospital | Not yet recruiting | Gwangju | 61469 | South Korea |
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| Kangbuk Samsung Hospital | Not yet recruiting | Seoul | 03181 | South Korea |
|
| Asan Medical Center | Not yet recruiting | Seoul | 05505 | South Korea |
|
| Seoul National University Boramae Hospital | Not yet recruiting | Seoul | 07061 | South Korea |
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| Korea University Guro Hospital | Not yet recruiting | Seoul | 08308 | South Korea |
|
| ID | Term |
|---|---|
| D016891 | Polycystic Kidney, Autosomal Dominant |
| ID | Term |
|---|---|
| D007690 | Polycystic Kidney Diseases |
| D052177 | Kidney Diseases, Cystic |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D000072661 | Ciliopathies |
| D030342 | Genetic Diseases, Inborn |
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