Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2025-12-28 @ 9:59 AM
Study NCT ID:
NCT04976166
Status:
UNKNOWN
Last Update Posted:
2022-03-25
First Post:
2021-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Shared Decision Making for Choosing renAl Replacement Therapy in Chronic Kidney Disease Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004522', 'term': 'Educational Status'}], 'ancestors': [{'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1194}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-02-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-09', 'studyFirstSubmitDate': '2021-06-21', 'studyFirstSubmitQcDate': '2021-07-18', 'lastUpdatePostDateStruct': {'date': '2022-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The ratio of hemodialysis to non-hemodialysis', 'timeFrame': '12 months', 'description': 'To compare the proportion of hemodialysis versus non-hemodialysis (peritoneal dialysis and kidney transplantation) treatments among the groups'}], 'secondaryOutcomes': [{'measure': 'Economic efficiency using a cost-utility analysis', 'timeFrame': 'Month 2, and 12', 'description': 'The incremental cost-utility ratio (ICUR) is calculated by the ratio of differences in costs and utilities.'}, {'measure': "Patients' satisfaction assessed by Patient Satisfaction Questionnaire (ZUF-8)", 'timeFrame': 'Month 0, 2, and 12', '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.'}, {'measure': "Patients' evaluation of the SDM process assessed by Shared Decision-Making Questionnaire (SDM-Q-9)", 'timeFrame': 'Month 0, 2, and 12', '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.'}, {'measure': "Patients' adherence to medication assessed by Morisky 8-item Medication Adherence Scale (MMAS-8)", 'timeFrame': 'Month 0, 2, and 12', '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).'}, {'measure': 'unplanned dialysis', 'timeFrame': '12 months', 'description': 'To compare the rate of unplanned dialysis among the groups'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['chronic kidney disease', 'dialysis', 'shared decision making'], 'conditions': ['Chronic Kidney Disease Stage 5']}, 'descriptionModule': {'briefSummary': "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).\n\nDespite 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.", 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with chronic kidney disease whose nephrologist predicts initiation of renal replacement therapy within 12 months:\n\n 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\\]\n 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\n 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\n* Patients aged between 19 and 80 years\n* Patients who understand the study\n* Patients who have no permanent access device for long-term maintenance dialysis\n\nExclusion Criteria:\n\n* Patients who have contraindication to perform peritoneal dialysis due to abdominal surgery\n* Patients whose life expectancy is less than 6 months due to underlying diseases\n* Patients who have enrolled in other clinical trials within 3 months or plan to participate in other clinical trials during this clinical trial period\n* Patients judged by the investigator to be inappropriate for participation in this clinical trial"}, 'identificationModule': {'nctId': 'NCT04976166', 'acronym': 'SDM-ART', 'briefTitle': 'Shared Decision Making for Choosing renAl Replacement Therapy in Chronic Kidney Disease Patients', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Shared Decision Making for Choosing renAl Replacement Therapy in Chronic Kidney Disease Patients (SDM-ART Trial)', 'orgStudyIdInfo': {'id': 'SDMART'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional group', '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.', 'interventionNames': ['Behavioral: Education']}, {'type': 'EXPERIMENTAL', 'label': 'Extensive Informed Decision Making group', '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.', 'interventionNames': ['Behavioral: Education']}, {'type': 'EXPERIMENTAL', 'label': 'Shared Decision Making group', '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.", 'interventionNames': ['Behavioral: Education']}], 'interventions': [{'name': 'Education', 'type': 'BEHAVIORAL', 'description': 'More informed and detailed education', 'armGroupLabels': ['Extensive Informed Decision Making group']}, {'name': 'Education', 'type': 'BEHAVIORAL', 'description': 'Shared decision making', 'armGroupLabels': ['Shared Decision Making group']}, {'name': 'Education', 'type': 'BEHAVIORAL', 'description': 'education as usual', 'armGroupLabels': ['Conventional group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13620', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sejoong Kim, MD,PhD', 'role': 'CONTACT', 'email': 'sejoong2@snu.ac.kr', 'phone': '+82-10-94964899'}], 'facility': 'Bundang Seoul National University Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}, {'city': 'Daegu', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Kyungpook National University Chilgok Hospital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Daegu', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Kyungpook National University Hospital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Daejeon', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Daejeon Eulji Medical Center', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'city': 'Goyang', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Dongguk University Ilsan Hospital', 'geoPoint': {'lat': 36.21689, 'lon': 127.19731}}, {'city': 'Gwangju', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Chonnam National University Hospital', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'city': 'Incheon', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Gachon University Gil Medical Center', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'city': 'Pusan', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Pusan National University Hospital', 'geoPoint': {'lat': 36.3809, 'lon': 128.3681}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': "Ewha Woman's University Seoul Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Korea University Guro Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Kyung Hee University Hospital at Gangdong', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Seoul National University Boramae Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': "The Catholic University of Korea Eunpyeong St. Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': "The Catholic University of Korea Seoul St. Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Ulsan', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Ulsan University Hospital', 'geoPoint': {'lat': 35.53722, 'lon': 129.31667}}, {'city': 'Wŏnju', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Yonsei University Wonju Severance Christian Hospital', 'geoPoint': {'lat': 37.35139, 'lon': 127.94528}}], 'centralContacts': [{'name': 'Sejoong Kim, MD,PhD', 'role': 'CONTACT', 'email': 'sejoong@snubh.org', 'phone': '+82-10-9496-4899'}], 'overallOfficials': [{'name': 'Sejoong Sejoong, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Bundang Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Sejoong Kim', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}