Ignite Creation Date:
2025-12-25 @ 4:35 AM
Ignite Modification Date:
2025-12-26 @ 3:37 AM
Study NCT ID:
NCT04289818
Status:
COMPLETED
Last Update Posted:
2022-11-02
First Post:
2020-02-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effectiveness of "CARE Coaching Model" as an Effort to Empower Type 2 Diabetes Mellitus Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-01', 'studyFirstSubmitDate': '2020-02-10', 'studyFirstSubmitQcDate': '2020-02-27', 'lastUpdatePostDateStruct': {'date': '2022-11-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline HbA1c at 3 months', 'timeFrame': '3 month after intervention', 'description': 'Glycemic Control'}, {'measure': 'Change from Baseline HbA1c at 6 months', 'timeFrame': '6 month after intervention', 'description': 'Glycemic Control'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline Fasting Plasma Glucose at 3 months', 'timeFrame': '3 month after intervention', 'description': 'Glycemic Control'}, {'measure': 'Change from Baseline 2-hours post prandial plasma glucose at 3 months', 'timeFrame': '3 months after intervention', 'description': 'Glycemic control'}, {'measure': 'Change from HDL-cholesterol at 3 months', 'timeFrame': '3 months after intervention', 'description': 'Diabetes mellitus control'}, {'measure': 'Change from LDL-cholesterol at 3 months', 'timeFrame': '3 months after intervention', 'description': 'Diabetes mellitus control'}, {'measure': 'Change from Triglycerides at 3 months', 'timeFrame': '3 months after intervention', 'description': 'diabetes mellitus control'}, {'measure': 'Change from Total Cholesterol at 3 months', 'timeFrame': '3 months after intervention', 'description': 'Diabetes mellitus control'}, {'measure': 'Change of Body mass index at 3 months', 'timeFrame': '3 month after intervention', 'description': 'Diabetes mellitus control'}, {'measure': 'Change calorie intake at 3 months', 'timeFrame': '3 month after intervention', 'description': 'life style parameter'}, {'measure': 'International Physical Activity Questionnaire (IPAQ) questionnaire', 'timeFrame': 'baseline, 3 month and 6 months after intervention', 'description': 'consist of several question about activities in the whole week. Scoring divided into 3 categories : low, moderate, high. This questionnaire is to describe activities no to divided whether high score means good or bad'}, {'measure': 'EQ-5D quality of life questionnaire', 'timeFrame': 'baseline, 3 month and 6 months after intervention', 'description': 'This questionnaire consist of several question with 5 main outcome mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Subjects will answer the question with fully, half or none.'}, {'measure': 'Change from Baseline Fasting Plasma Glucose at 6 months', 'timeFrame': '6 month after intervention', 'description': 'Glycemic Control'}, {'measure': 'Change from Baseline 2-hours post prandial plasma glucose at 6 months', 'timeFrame': '6 months after intervention', 'description': 'Glycemic Control'}, {'measure': 'Change from HDL-cholesterol at 6 months', 'timeFrame': '6 months after intervention', 'description': 'diabetes mellitus Control'}, {'measure': 'Change from LDL-cholesterol at 6 months', 'timeFrame': '6 months after intervention', 'description': 'diabetes mellitus Control'}, {'measure': 'Change from Triglycerides at 6 months', 'timeFrame': '6 months after intervention', 'description': 'diabetes mellitus Control'}, {'measure': 'Change from Total Cholesterol at 6 months', 'timeFrame': '6 months after intervention', 'description': 'diabetes mellitus Control'}, {'measure': 'Change from systolic and diastolic blood pressure at 6 months', 'timeFrame': '6 months after intervention', 'description': 'diabetes mellitus Control'}, {'measure': 'Change calorie intake at 6 months', 'timeFrame': '6 months after intervention', 'description': 'life style parameter'}, {'measure': 'Change of Body mass index at 6 months', 'timeFrame': '6 months after intervention', 'description': 'diabetes mellitus control'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetes Mellitus', 'Health coaching'], 'conditions': ['Diabetes Type 2']}, 'descriptionModule': {'briefSummary': 'In Indonesia and others countries, only 30.8% patients with type 2 diabetes mellitus (T2DM) achieved glycemic control with HbA1c \\<7%. Optimal pharmacological treatment alone does not guarantee an optimal outcome, therefore it should be combined with lifestyle management. Health coaching helps T2DM patients increase self awareness to improve and maintain behavior which play a role in self-management. This study aims to evaluate the impact of health coaching on glycemic control on T2DM patients.', 'detailedDescription': 'Subjects randomized into 2 groups: control and intervention group. All subject received education class in top of standard treatment. Intervention group received additional personal health coaching.\n\nEducation and health coaching was given for 12 sessions every 2 weeks with 12 different themes for each session. Health coaching were given by International certified health coach.\n\nLaboratory examination and questionnaire collected at baseline, 3 and 6 months after intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* T2DM patients\n* aged 30-60 years old\n* HbA1C \\> 7.5% within the past 3 months\n* able to write and read.\n\nExclusion Criteria:\n\n* Patients with cognitive disease (such as dementia)\n* having hearing problem or sight problem\n* unable to live independently on daily basis\n* having disease that may affect HbA1c result (eg: hemolytic anemia)'}, 'identificationModule': {'nctId': 'NCT04289818', 'briefTitle': 'The Effectiveness of "CARE Coaching Model" as an Effort to Empower Type 2 Diabetes Mellitus Patients', 'organization': {'class': 'OTHER', 'fullName': 'Indonesia University'}, 'officialTitle': 'Efektivitas "CARE Coaching Model" Sebagai Upaya Pemberdayaan Pasien Diabetes Untuk Meningkatkan Status Kesehatan Dan Perilaku Pengendalian Diabetes', 'orgStudyIdInfo': {'id': 'PS002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Conventional Education Class'}, {'type': 'EXPERIMENTAL', 'label': 'Coaching', 'description': 'Health Coaching', 'interventionNames': ['Other: Health Coaching']}], 'interventions': [{'name': 'Health Coaching', 'type': 'OTHER', 'description': 'Health Coaching as face to face with a coach', 'armGroupLabels': ['Coaching']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10430', 'city': 'Jakarta Pusat', 'state': 'DKI Jakarta', 'country': 'Indonesia', 'facility': 'Faculty of Medicine, Universitas Indonesia', 'geoPoint': {'lat': -6.1818, 'lon': 106.8223}}], 'overallOfficials': [{'name': 'Pradana Soewondo, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fakultas Kedokteran Universitas Indonesia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indonesia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Endocrinologist', 'investigatorFullName': 'Prof. Dr. dr. Pradana Soewondo, SpPD-KEMD', 'investigatorAffiliation': 'Indonesia University'}}}}