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Shared Decision Making for Choosing renAl Replacement Therapy in Chronic Kidney Disease Patients (SDM-ART Trial)
Shared decision making (SDM) is an approach where clinicians and patients make decisions together using the best available evidence. An understanding of the patient's treatment goals, the advantages and disadvantages of treatment options, and the likelihood of achieving the outcomes are important to patients. International guidelines recommend that all patients with chronic kidney disease (CKD) at pre-dialysis stage should be educated to improve their knowledge and understanding of their condition and to choose the options for renal replacement therapy (RRT). 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.
This study will be conducted as a multicenter, open-label, randomized, pragmatic clinical trial. A total of 1,194 participants with CKD considering RRT will be randomized into 3 groups. Patients in the conventional group will have education using leaflets. Patients in the extensive informed decision making (EIDM) group will receive more detailed education using intensive learning materials than those in the conventional group. Shared decision making (SDM) group patients will have education according to questionnaires of self-assessment items using a self-developed counseling calendar.
Age
19 - 80 years
Sex
ALL
Healthy Volunteers
No
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
Start Date
February 26, 2021
Primary Completion Date
December 1, 2024
Completion Date
December 1, 2024
Last Updated
March 25, 2022
1,194
ESTIMATED participants
Education
BEHAVIORAL
Education
BEHAVIORAL
Education
BEHAVIORAL
Lead Sponsor
Seoul National University Hospital
NCT06495385
NCT07446296
Data Source & Attribution
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