Shared Decision Making for Choosing renAl Replacement Therapy in Chronic Kidney Disease Patients
SDM-ART
1 other identifier
interventional
1,194
1 country
19
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2021
Longer than P75 for not_applicable
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 26, 2021
CompletedFirst Submitted
Initial submission to the registry
June 21, 2021
CompletedFirst Posted
Study publicly available on registry
July 26, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedMarch 25, 2022
March 1, 2022
3.8 years
June 21, 2021
March 9, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The ratio of hemodialysis to non-hemodialysis
To compare the proportion of hemodialysis versus non-hemodialysis (peritoneal dialysis and kidney transplantation) treatments among the groups
12 months
Secondary Outcomes (5)
Economic efficiency using a cost-utility analysis
Month 2, and 12
Patients' satisfaction assessed by Patient Satisfaction Questionnaire (ZUF-8)
Month 0, 2, and 12
Patients' evaluation of the SDM process assessed by Shared Decision-Making Questionnaire (SDM-Q-9)
Month 0, 2, and 12
Patients' adherence to medication assessed by Morisky 8-item Medication Adherence Scale (MMAS-8)
Month 0, 2, and 12
unplanned dialysis
12 months
Study Arms (3)
Conventional group
ACTIVE COMPARATORVideos and leaflets will be provided. Patients will have education using leaflets for 5 minutes in each hospital at months 0 and 2, respectively.
Extensive Informed Decision Making group
EXPERIMENTALVideos, 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.
Shared Decision Making group
EXPERIMENTALVideos, 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.
Interventions
Eligibility Criteria
You may qualify if:
- Patients with chronic kidney disease whose nephrologist predicts initiation of renal replacement therapy within 12 months:
- Patients with grade 5 of chronic kidney disease \[defined as a creatinine-based estimated glomerular filtration rate (eGFR) \< 15 ml/dL/1.73m2 at least 2 times at intervals of 2 weeks or longer\]
- 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
- 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
You may not qualify if:
- Patients who have contraindication to perform peritoneal dialysis due to abdominal surgery
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Bundang Seoul National University Hospital
Seongnam-si, Gyeonggi-do, 13620, 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sejoong Sejoong, MD,PhD
Seoul National University Bundang Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 21, 2021
First Posted
July 26, 2021
Study Start
February 26, 2021
Primary Completion
December 1, 2024
Study Completion
December 1, 2024
Last Updated
March 25, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share