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NCT Number: NCT04976166

Shared Decision Making for Choosing renAl Replacement Therapy in Chronic Kidney Disease Patients

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.

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Key information

Conditions

Chronic Kidney Disease Stage 5 Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bundang Seoul National University Hospital, Seongnam-si, Gyeonggi-do, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Education

Behavioral

More informed and detailed education

Primary outcomes

  1. 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

Secondary outcomes

  1. Economic efficiency using a cost-utility analysis

    Time frame: Month 2, and 12

    The incremental cost-utility ratio (ICUR) is calculated by the ratio of differences in costs and utilities.

  2. Patients' satisfaction assessed by Patient Satisfaction Questionnaire (ZUF-8)

    Time frame: Month 0, 2, and 12

    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.

  3. Patients' evaluation of the SDM process assessed by Shared Decision-Making Questionnaire (SDM-Q-9)

    Time frame: Month 0, 2, and 12

    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.

  4. Patients' adherence to medication assessed by Morisky 8-item Medication Adherence Scale (MMAS-8)

    Time frame: Month 0, 2, and 12

    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).

  5. unplanned dialysis

    Time frame: 12 months

    To compare the rate of unplanned dialysis among the groups

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Acronym: SDM-ART

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jul 26, 2021
Registry last updated
Sep 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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