Shared Decision Making for Choosing renAl Replacement Therapy in Chronic Kidney Disease Patients (SDM-ART)

  • STATUS
    Recruiting
  • End date
    Dec 9, 2024
  • participants needed
    1194
  • sponsor
    Seoul National University Hospital
Updated on 9 April 2022

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.

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.

Details
Condition Chronic Kidney Disease Stage 5
Treatment Education
Clinical Study IdentifierNCT04976166
SponsorSeoul National University Hospital
Last Modified on9 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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