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

Primary Purpose

Chronic Kidney Disease Stage 5

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Education
Education
Education
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease Stage 5 focused on measuring chronic kidney disease, dialysis, shared decision making

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with chronic kidney disease whose nephrologist predicts initiation of renal replacement therapy within 12 months:

    1. 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]
    2. 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
    3. 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

Sites / Locations

  • Bundang Seoul National University HospitalRecruiting
  • Kyungpook National University Chilgok HospitalRecruiting
  • Kyungpook National University HospitalRecruiting
  • Daejeon Eulji Medical CenterRecruiting
  • Dongguk University Ilsan HospitalRecruiting
  • Chonnam National University HospitalRecruiting
  • Gachon University Gil Medical CenterRecruiting
  • Pusan National University HospitalRecruiting
  • Ewha Woman's University Seoul HospitalRecruiting
  • Korea University Guro HospitalRecruiting
  • Kyung Hee University Hospital at GangdongRecruiting
  • Samsung Medical CenterRecruiting
  • Seoul National University Boramae Medical CenterRecruiting
  • Seoul National University HospitalRecruiting
  • Severance HospitalRecruiting
  • The Catholic University of Korea Eunpyeong St. Mary's HospitalRecruiting
  • The Catholic University of Korea Seoul St. Mary's HospitalRecruiting
  • Ulsan University HospitalRecruiting
  • Yonsei University Wonju Severance Christian HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Conventional group

Extensive Informed Decision Making group

Shared Decision Making group

Arm Description

Videos and leaflets will be provided. Patients will have education using leaflets for 5 minutes in each hospital at months 0 and 2, respectively.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Economic efficiency using a cost-utility analysis
The incremental cost-utility ratio (ICUR) is calculated by the ratio of differences in costs and utilities.
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.
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.
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).
unplanned dialysis
To compare the rate of unplanned dialysis among the groups

Full Information

First Posted
June 21, 2021
Last Updated
March 9, 2022
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04976166
Brief Title
Shared Decision Making for Choosing renAl Replacement Therapy in Chronic Kidney Disease Patients
Acronym
SDM-ART
Official Title
Shared Decision Making for Choosing renAl Replacement Therapy in Chronic Kidney Disease Patients (SDM-ART Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 26, 2021 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease Stage 5
Keywords
chronic kidney disease, dialysis, shared decision making

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1194 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional group
Arm Type
Active Comparator
Arm Description
Videos and leaflets will be provided. Patients will have education using leaflets for 5 minutes in each hospital at months 0 and 2, respectively.
Arm Title
Extensive Informed Decision Making group
Arm Type
Experimental
Arm Description
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.
Arm Title
Shared Decision Making group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Education
Intervention Description
More informed and detailed education
Intervention Type
Behavioral
Intervention Name(s)
Education
Intervention Description
Shared decision making
Intervention Type
Behavioral
Intervention Name(s)
Education
Intervention Description
education as usual
Primary Outcome Measure Information:
Title
The ratio of hemodialysis to non-hemodialysis
Description
To compare the proportion of hemodialysis versus non-hemodialysis (peritoneal dialysis and kidney transplantation) treatments among the groups
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Economic efficiency using a cost-utility analysis
Description
The incremental cost-utility ratio (ICUR) is calculated by the ratio of differences in costs and utilities.
Time Frame
Month 2, and 12
Title
Patients' satisfaction assessed by Patient Satisfaction Questionnaire (ZUF-8)
Description
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.
Time Frame
Month 0, 2, and 12
Title
Patients' evaluation of the SDM process assessed by Shared Decision-Making Questionnaire (SDM-Q-9)
Description
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.
Time Frame
Month 0, 2, and 12
Title
Patients' adherence to medication assessed by Morisky 8-item Medication Adherence Scale (MMAS-8)
Description
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).
Time Frame
Month 0, 2, and 12
Title
unplanned dialysis
Description
To compare the rate of unplanned dialysis among the groups
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sejoong Kim, MD,PhD
Phone
+82-10-9496-4899
Email
sejoong@snubh.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sejoong Sejoong, MD,PhD
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bundang Seoul National University Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sejoong Kim, MD,PhD
Phone
+82-10-94964899
Email
sejoong2@snu.ac.kr
Facility Name
Kyungpook National University Chilgok Hospital
City
Daegu
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Kyungpook National University Hospital
City
Daegu
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Daejeon Eulji Medical Center
City
Daejeon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Dongguk University Ilsan Hospital
City
Goyang
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Chonnam National University Hospital
City
Gwangju
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Gachon University Gil Medical Center
City
Incheon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Pusan National University Hospital
City
Pusan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Ewha Woman's University Seoul Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Korea University Guro Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Kyung Hee University Hospital at Gangdong
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Boramae Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Severance Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
The Catholic University of Korea Eunpyeong St. Mary's Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
The Catholic University of Korea Seoul St. Mary's Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Ulsan University Hospital
City
Ulsan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Yonsei University Wonju Severance Christian Hospital
City
Wonju
Country
Korea, Republic of
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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

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