Shared Decision Making for Choosing renAl Replacement Therapy in Chronic Kidney Disease Patients
NCT ID: NCT04976166
Last Updated: 2022-03-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
1194 participants
INTERVENTIONAL
2021-02-26
2024-12-31
Brief Summary
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Despite these recommendations, pre-dialysis educations are often infrequent. Many patients feel unprepared. Wrong or insufficient understanding due to insufficient explanation of treatment can lead to negative emotions. This may lead to a situation in which the patient loses the opportunity to make patient's own choices, resulting in emergency dialysis or dialysis modality that is not suitable for patients. Therefore, this study aims to evaluate whether SDM has an effect on the choice of RRT among CKD patients.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Conventional group
Videos and leaflets will be provided. Patients will have education using leaflets for 5 minutes in each hospital at months 0 and 2, respectively.
Education
education as usual
Extensive Informed Decision Making group
Videos, leaflets, and intensive learning materials will be provided. Patients in the EIDM group will receive more informed and detailed education than those in the conventional group. Patients will have education for more than 10 minutes at months 0 and 2, respectively.
Education
More informed and detailed education
Shared Decision Making group
Videos, leaflets, and intensive learning materials will be provided. Patients will check self-assessment items, and then have education according to the patients' preference using a self-developed counseling calendar. Patients will have education for more than 10 minutes at months 0 and 2, respectively.
Education
Shared decision making
Interventions
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Education
More informed and detailed education
Education
Shared decision making
Education
education as usual
Eligibility Criteria
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Inclusion Criteria
1. Patients with grade 5 of chronic kidney disease \[defined as a creatinine-based estimated glomerular filtration rate (eGFR) \< 15 ml/dL/1.73m2 at least 2 times at intervals of 2 weeks or longer\]
2. Patients with the cystatin C-based eGFR \< 15 ml/dL/1.73m2 at least once if the creatinine-based eGFR does not accurately evaluate the kidney function of patient due to patient characteristics
3. Patients whose nephrologist require renal replacement therapy within 12 months due to the patient's comorbidities even when the eGFR is 15ml/dL/1.73m2 or higher
* Patients aged between 19 and 80 years
* Patients who understand the study
* Patients who have no permanent access device for long-term maintenance dialysis
Exclusion Criteria
* Patients whose life expectancy is less than 6 months due to underlying diseases
* Patients who have enrolled in other clinical trials within 3 months or plan to participate in other clinical trials during this clinical trial period
* Patients judged by the investigator to be inappropriate for participation in this clinical trial
19 Years
80 Years
ALL
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Sejoong Kim
Professor
Principal Investigators
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Sejoong Sejoong, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Bundang Hospital
Locations
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Bundang Seoul National University Hospital
Seongnam-si, Gyeonggi-do, South Korea
Kyungpook National University Chilgok Hospital
Daegu, , South Korea
Kyungpook National University Hospital
Daegu, , South Korea
Daejeon Eulji Medical Center
Daejeon, , South Korea
Dongguk University Ilsan Hospital
Goyang, , South Korea
Chonnam National University Hospital
Gwangju, , South Korea
Gachon University Gil Medical Center
Incheon, , South Korea
Pusan National University Hospital
Pusan, , South Korea
Ewha Woman's University Seoul Hospital
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Kyung Hee University Hospital at Gangdong
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Seoul National University Boramae Medical Center
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital
Seoul, , South Korea
The Catholic University of Korea Eunpyeong St. Mary's Hospital
Seoul, , South Korea
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul, , South Korea
Ulsan University Hospital
Ulsan, , South Korea
Yonsei University Wonju Severance Christian Hospital
Wŏnju, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SDMART
Identifier Type: -
Identifier Source: org_study_id
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