Chronic Kidney Disease Stage 5SDM-ARTNCT04976166
Shared Decision Making for Choosing renAl Replacement Therapy in Chronic Kidney Disease Patients
A study testing Education in people with Chronic Kidney Disease Stage 5, run by Seoul National University Hospital at 19 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Chronic Kidney Disease Stage 5
- What is being tested?
- Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,194 participants
- Where
- 19 sitesSouth Korea
- Study dates
- 26 Feb 2021to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
South Korea19 sites
Kyungpook National University Chilgok Hospital
Daegu
Kyungpook National University Hospital
Daegu
Daejeon Eulji Medical Center
Daejeon
Dongguk University Ilsan Hospital
Goyang
Chonnam National University Hospital
Gwangju
Gachon University Gil Medical Center
Incheon
Pusan National University Hospital
Pusan
Bundang Seoul National University Hospital
Seongnam-si, Gyeonggi-do, 13620
Ewha Woman's University Seoul Hospital
Seoul
Korea University Guro Hospital
Seoul
Kyung Hee University Hospital at Gangdong
Seoul
Samsung Medical Center
Seoul
Seoul National University Boramae Medical Center
Seoul
Seoul National University Hospital
Seoul
Severance Hospital
Seoul
The Catholic University of Korea Eunpyeong St. Mary's Hospital
Seoul
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul
Ulsan University Hospital
Ulsan
Yonsei University Wonju Severance Christian Hospital
Wŏnju
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Chronic Kidney Disease Stage 5
- Being tested
- Education
- Keywords
- chronic kidney disease, dialysis, shared decision making
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationBehavioural
More informed and detailed education
EducationBehavioural
Shared decision making
EducationBehavioural
education as usual
| Study group | Role | What they receive |
|---|---|---|
| Conventional group | Active comparator | Videos and leaflets will be provided. Patients will have education using leaflets for 5 minutes in each hospital at months 0 and 2, respectively. Receives: Behavioral: Education |
| Extensive Informed Decision Making group | Experimental | 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. Receives: Behavioral: Education |
| Shared Decision Making group | Experimental | 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. Receives: Behavioral: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (5)
Economic efficiency using a cost-utility analysis
The incremental cost-utility ratio (ICUR) is calculated by the ratio of differences in costs and utilities.
Measured: Month 2, and 12
Patients' satisfaction assessed by Patient Satisfaction Questionnaire (ZUF-8)
The ZUF-8 is an 8-items questionnaire to assess satisfaction in patients using a scale from 1,"poor" to 4,"excellent". Originally, ZUF-8 used a 4-point scale, but in this study, the investigators further extended the scoring system of this questionnaire from four to five incremental stages of perceived satisfaction, i.e. "poor (1)," rather good (2)," good (3)," very good (4)," extraordinary (5)". The minimum value is 8 and the maximum value is 40. Higher scores mean a better outcome.
Measured: Month 0, 2, and 12
Patients' evaluation of the SDM process assessed by Shared Decision-Making Questionnaire (SDM-Q-9)
The SDM-Q-9 questionnaire is a nine item measure. Items are reported with six response options ranging from 0, "completely disagree", to 5, "completely agree". In this study, six response options were converted into five incremental stages, i.e. "strongly disagree (1)," somewhat disagree (2)," neither disagree nor agree (3)," somewhat agree (4)," strongly agree (5)". To calculate the total scale score, items are summed resulting in a range from 9-45. Higher scores reflect a participant's participation in shared decision making regarding their treatment.
Measured: Month 0, 2, and 12
Patients' adherence to medication assessed by Morisky 8-item Medication Adherence Scale (MMAS-8)
The MMAS-8 is an 8-items questionnaire and the scale included 7 items with yes/no response options and 1 item with a 5-point Likert scale response option. Cumulative score based on 8 items are used to obtain final adherence score ranging from 0 to 8. Adherence is defined accordingly as low (score 0-5), medium (score 6-7) and high (score 8).
Measured: Month 0, 2, and 12
unplanned dialysis
To compare the rate of unplanned dialysis among the groups
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2021
- Study start26 Feb 2021
- Primary completion31 Jul 2026
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease Stage 5Studies 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
- 1,194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sejoong Kim, Seoul National University Hospital
- Investigators
- Sejoong Sejoong, MD,PhD, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04976166
- Sponsor's protocol ID
- SDMART
- Acronym
- SDM-ART
- Status last verified
- Sep 2026
- First submitted
- 21 Jun 2021
- Last updated
- 8 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shared Decision Making for Choosing renAl Replacement Therapy in Chronic Kidney Disease Patients (SDM-ART Trial)
- ClinicalTrials.gov ID
- NCT04976166
- Acronym / sponsor ID
- SDM-ART / SDMART
- Conditions
- Chronic Kidney Disease Stage 5
- Keywords
- chronic kidney disease, dialysis, shared decision making
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,194 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 26 Feb 2021 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 26 Jul 2021 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional group | Active comparator | Behavioral: EducationVideos 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 | Experimental | Behavioral: EducationVideos, 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 | Experimental | Behavioral: EducationVideos, 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. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with chronic kidney disease whose nephrologist predicts initiation of renal replacement therapy within 12 months:
- Patients aged between 19 and 80 years
- Patients who understand the study
- Patients who have no permanent access device for long-term maintenance dialysis
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| EducationMore informed and detailed education | Behavioural | Extensive Informed Decision Making group |
| EducationShared decision making | Behavioural | Shared Decision Making group |
| Educationeducation as usual | Behavioural | Conventional group |
Primary outcome
The ratio of hemodialysis to non-hemodialysis
Time frame: 12 months
To compare the proportion of hemodialysis versus non-hemodialysis (peritoneal dialysis and kidney transplantation) treatments among the groups
5 secondary outcomes
Economic efficiency using a cost-utility analysis
Time frame: Month 2, and 12
Patients' satisfaction assessed by Patient Satisfaction Questionnaire (ZUF-8)
Time frame: Month 0, 2, and 12
Patients' evaluation of the SDM process assessed by Shared Decision-Making Questionnaire (SDM-Q-9)
Time frame: Month 0, 2, and 12
Patients' adherence to medication assessed by Morisky 8-item Medication Adherence Scale (MMAS-8)
Time frame: Month 0, 2, and 12
unplanned dialysis
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Sejoong Sejoong, MD,PhD principal investigator
Seoul National University Bundang Hospital
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education in people with Chronic Kidney Disease Stage 5, run by Seoul National University Hospital at 19 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 7 inclusion and 4 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: finished, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The ratio of hemodialysis to non-hemodialysis (time frame: 12 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 8 Sep 2026.