Ignite Creation Date:
2025-12-24 @ 7:19 PM
Ignite Modification Date:
2026-02-27 @ 10:05 AM
Study NCT ID:
NCT06688903
Status:
RECRUITING
Last Update Posted:
2025-02-25
First Post:
2024-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
App-based Diabetes Management and Community-based Interventions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-23', 'studyFirstSubmitDate': '2024-11-12', 'studyFirstSubmitQcDate': '2024-11-12', 'lastUpdatePostDateStruct': {'date': '2025-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HbA1c', 'timeFrame': '6 months', 'description': 'HbA1c over 6 months'}], 'secondaryOutcomes': [{'measure': 'Physical activity as measured by number of steps', 'timeFrame': '6 months', 'description': 'Physical activity over 6 months'}, {'measure': 'Physical activity as measured by moderate to vigorous active minutes', 'timeFrame': '6 months', 'description': 'Physical activity over 6 months'}, {'measure': 'Physical activity as measured by GPAQ', 'timeFrame': '6 months', 'description': 'Physical activity as measured by GPAQ'}, {'measure': 'Patient activation score as measured by patient activation measure', 'timeFrame': '6 months', 'description': 'Difference in patient activation score between intervention and control over 6 months'}, {'measure': 'Medication adherence as measured by MARS-5', 'timeFrame': '6 months', 'description': 'Difference in medication adherence between intervention and control over 6 months'}, {'measure': 'Quality of life as measured by EQ-5D-5L', 'timeFrame': '6 months', 'description': 'Difference in quality of life between intervention and control over 6 months'}, {'measure': 'Healthcare cost as measured by cost of consultations, lab tests, medications, admission', 'timeFrame': '6 months', 'description': 'Healthcare cost over 6 months'}, {'measure': 'Healthcare cost as measured by WPAI', 'timeFrame': '6 months', 'description': 'Healthcare cost over 6 months'}, {'measure': 'Maintenance of the intervention effects on HbA1c', 'timeFrame': '6 months', 'description': 'HbA1c over 6 months after the 6-month intervention'}, {'measure': 'Maintenance of the intervention effects on blood pressure', 'timeFrame': '6 months', 'description': 'Blood pressure over 6 months after the 6-month intervention'}, {'measure': 'Maintenance of the intervention effects on total cholesterol', 'timeFrame': '6 months', 'description': 'Total cholesterol over 6 months after the 6-month intervention'}, {'measure': 'Maintenance of the intervention effects on high-density lipoprotein (HDL)', 'timeFrame': '6 months', 'description': 'HDL over 6 months after the 6-month intervention'}, {'measure': 'Maintenance of the intervention effects on low-density lipoprotein (LDL)', 'timeFrame': '6 months', 'description': 'LDL over 6 months after the 6-month intervention'}, {'measure': 'Maintenance of the intervention effects on triglycerides', 'timeFrame': '6 months', 'description': 'Triglycerides over 6 months after the 6-month intervention'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus Type 2']}, 'descriptionModule': {'briefSummary': 'Community-based health coaching interventions play a vital role in complementing the traditional chronic disease management model for type 2 diabetes patients. Compared to conventional approaches that often focus on periodic clinical visits, community-based coaching could provide continuous, personalised support within patients in everyday environments. Health coaches work directly with patients to set realistic goals, develop individualised action plans, and provide ongoing motivation and accountability. This personalised attention helps to improve self-management skills, such as medication adherence, dietary choices, and physical activity, which are crucial for chronic disease management and preventing complications. Our mobile health app, EMPOWER+ has multiple logging features, gamified elements to help users set goals and provide rewards, educational resources, and personalised nudges generated based on real users; inputs and predictive modeling. It has demonstrated some preliminary effectiveness and acceptability within the clinical settings. This trial aims to assess its effectiveness, adoption, and sustainability in the less-controlled community settings, preparing for its large implementation in the future.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 21 years and above\n* Having been diagnosed with type 2 diabetes mellitus\n* Having most recent HbA1c ≥ 6.5%\n* Physically able to exercise\n* Able to read, write, and converse in English\n* Able to comply with study procedures\n\nExclusion Criteria:\n\n* Requiring assistance with basic activities of daily living (BADL)\n* Have planned major operation or surgical procedure within 6 months from the time of recruitment\n* Current pregnant or lactating'}, 'identificationModule': {'nctId': 'NCT06688903', 'briefTitle': 'App-based Diabetes Management and Community-based Interventions', 'organization': {'class': 'OTHER', 'fullName': 'Singapore General Hospital'}, 'officialTitle': 'EMPOWERing Patients With Chronic Diseases Through Smartphone App, Health Coaching and Community-based Intervention', 'orgStudyIdInfo': {'id': '202409-00001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'interventionNames': ['Behavioral: App-based diabetes management and community-based health coaching']}], 'interventions': [{'name': 'App-based diabetes management and community-based health coaching', 'type': 'BEHAVIORAL', 'description': 'All participants will use the EMPOWER+ app and a Fitbit wearable. They will also received community-based health coaching and/or other prescribed structured programmes.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Singapore', 'status': 'NOT_YET_RECRUITING', 'country': 'Singapore', 'contacts': [{'name': 'Lian Leng Low', 'role': 'CONTACT', 'email': 'low.lian.leng@singhealth.com.sg', 'phone': '91051097'}], 'facility': 'Singapore General Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'city': 'Singapore', 'status': 'RECRUITING', 'country': 'Singapore', 'contacts': [{'name': 'Research coordinators', 'role': 'CONTACT', 'email': 'empower@singhealth.com.sg', 'phone': '6562223222'}, {'name': 'Lian Leng Low, Masters', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Singapore General Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'centralContacts': [{'name': 'Research coordinators', 'role': 'CONTACT', 'email': 'empower@singhealth.com.sg', 'phone': '6562223222'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Singapore General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}