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

NCT ID: NCT04976166

Last Updated: 2022-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1194 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-26

Study Completion Date

2024-12-31

Brief Summary

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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

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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

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Chronic Kidney Disease Stage 5

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Conventional group

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

Group Type ACTIVE_COMPARATOR

Education

Intervention Type BEHAVIORAL

education as usual

Extensive Informed Decision Making group

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.

Group Type EXPERIMENTAL

Education

Intervention Type BEHAVIORAL

More informed and detailed education

Shared Decision Making group

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.

Group Type EXPERIMENTAL

Education

Intervention Type BEHAVIORAL

Shared decision making

Interventions

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Education

More informed and detailed education

Intervention Type BEHAVIORAL

Education

Shared decision making

Intervention Type BEHAVIORAL

Education

education as usual

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sejoong Kim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sejoong Sejoong, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

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Bundang Seoul National University Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status RECRUITING

Kyungpook National University Chilgok Hospital

Daegu, , South Korea

Site Status RECRUITING

Kyungpook National University Hospital

Daegu, , South Korea

Site Status RECRUITING

Daejeon Eulji Medical Center

Daejeon, , South Korea

Site Status RECRUITING

Dongguk University Ilsan Hospital

Goyang, , South Korea

Site Status RECRUITING

Chonnam National University Hospital

Gwangju, , South Korea

Site Status RECRUITING

Gachon University Gil Medical Center

Incheon, , South Korea

Site Status RECRUITING

Pusan National University Hospital

Pusan, , South Korea

Site Status RECRUITING

Ewha Woman's University Seoul Hospital

Seoul, , South Korea

Site Status RECRUITING

Korea University Guro Hospital

Seoul, , South Korea

Site Status RECRUITING

Kyung Hee University Hospital at Gangdong

Seoul, , South Korea

Site Status RECRUITING

Samsung Medical Center

Seoul, , South Korea

Site Status RECRUITING

Seoul National University Boramae Medical Center

Seoul, , South Korea

Site Status RECRUITING

Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Severance Hospital

Seoul, , South Korea

Site Status RECRUITING

The Catholic University of Korea Eunpyeong St. Mary's Hospital

Seoul, , South Korea

Site Status RECRUITING

The Catholic University of Korea Seoul St. Mary's Hospital

Seoul, , South Korea

Site Status RECRUITING

Ulsan University Hospital

Ulsan, , South Korea

Site Status RECRUITING

Yonsei University Wonju Severance Christian Hospital

Wŏnju, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Sejoong Kim, MD,PhD

Role: CONTACT

+82-10-9496-4899

Facility Contacts

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Sejoong Kim, MD,PhD

Role: primary

+82-10-94964899

Other Identifiers

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SDMART

Identifier Type: -

Identifier Source: org_study_id

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