Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-28 @ 6:44 PM
Study NCT ID:
NCT05097534
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-12-24
First Post:
2021-09-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comprehensive Community Approach for Diabetes Prevention and Care for a Vulnerable Population in Galveston
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2021-12-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-17', 'studyFirstSubmitDate': '2021-09-22', 'studyFirstSubmitQcDate': '2021-10-15', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline HbA1c', 'timeFrame': 'at 6 months', 'description': 'measurement of hemoglobin A1c (HbA1c %)'}, {'measure': 'Change from baseline HbA1c', 'timeFrame': 'at 12 months', 'description': 'measurement of hemoglobin A1c (HbA1c %)'}], 'secondaryOutcomes': [{'measure': 'Change from baseline weight', 'timeFrame': 'at 6 months', 'description': 'measurement of body weight in Kg'}, {'measure': 'Change from baseline weight', 'timeFrame': 'at 12 months', 'description': 'measurement of body weight in Kg'}, {'measure': 'Change from baseline blood pressure', 'timeFrame': 'at 6 months', 'description': 'measurement of systolic and diastolic blood pressure in mm Hg'}, {'measure': 'Change from baseline blood pressure', 'timeFrame': 'at 12 months', 'description': 'measurement of systolic and diastolic blood pressure in mm Hg'}, {'measure': 'Change from baseline lipid profile', 'timeFrame': 'at 6 months', 'description': 'measurement of lipid profile: Total Cholesterol, Triglycerides, High-Density Lipoprotein, and Low-Density Lipoprotein in mg/dL'}, {'measure': 'Change from baseline lipid profile', 'timeFrame': 'at 12 months', 'description': 'measurement of lipid profile: Total Cholesterol, Triglycerides, High-Density Lipoprotein, and Low-Density Lipoprotein in mg/dL'}, {'measure': 'Change from baseline frequency of provider encounter', 'timeFrame': 'at 6 months', 'description': 'Frequency of provider encounter'}, {'measure': 'Change from baseline frequency of provider encounter', 'timeFrame': 'at 12 months', 'description': 'Frequency of provider encounter'}, {'measure': 'Change from baseline frequency of feet examination for neuropathy', 'timeFrame': 'at 6 months', 'description': 'Frequency of feet examination for neuropathy'}, {'measure': 'Change from baseline frequency of feet examination for neuropathy', 'timeFrame': 'at 12 months', 'description': 'Frequency of feet examination for neuropathy'}, {'measure': 'Change from baseline frequency of urine exam for microalbuminuria', 'timeFrame': 'at 6 months', 'description': 'Frequency of urine exam for microalbuminuria'}, {'measure': 'Change from baseline frequency of urine exam for microalbuminuria', 'timeFrame': 'at 12 months', 'description': 'Frequency of urine exam for microalbuminuria'}, {'measure': 'Change from baseline frequency of oral health checkup', 'timeFrame': 'at 6 months', 'description': 'Frequency of oral health checkup'}, {'measure': 'Change from baseline frequency of oral health checkup', 'timeFrame': 'at 12 months', 'description': 'Frequency of oral health checkup'}, {'measure': 'Change from baseline frequency of eye fundus examination', 'timeFrame': 'at 6 months', 'description': 'Frequency of eye fundus examination'}, {'measure': 'Change from baseline frequency of eye fundus examination', 'timeFrame': 'at 12 months', 'description': 'Frequency of eye fundus examination'}, {'measure': 'Change from baseline frequency of emergency care visits for treatment of T2-related issues', 'timeFrame': 'at 6 months', 'description': 'Frequency of emergency care visits for treatment of T2-related issues'}, {'measure': 'Change from baseline frequency of emergency care visits for treatment of T2-related issues', 'timeFrame': 'at 12 months', 'description': 'Frequency of emergency care visits for treatment of T2-related issues'}, {'measure': 'Change from baseline frequency of hospitalizations and re-admissions', 'timeFrame': 'at 6 months', 'description': 'Frequency of hospitalizations and re-admissions'}, {'measure': 'Change from baseline frequency of hospitalizations and re-admissions', 'timeFrame': 'at 12 months', 'description': 'Frequency of hospitalizations and re-admissions'}, {'measure': 'Participation in iDSMES classes (for those in the intervention arm only)', 'timeFrame': 'at 12 months', 'description': 'Participation in iDSMES classes (total number of sessions attended)'}, {'measure': 'Lifestyle change outcomes (for those in the intervention arm only)', 'timeFrame': 'every session through study completion, an average of 1 year', 'description': 'Physical activity minutes in the last week prior to session'}, {'measure': 'Change from baseline patient-centeredness', 'timeFrame': 'at 6 months', 'description': 'General self-rated Health (GSRH): a single item survey- self-administered single question such as "in general, would you say that your health is? excellent, very good, good, fair, or poor?", where excellent is scored as "5" and poor is scored as "0".'}, {'measure': 'Change from baseline patient-centeredness', 'timeFrame': 'at 12 months', 'description': 'General self-rated Health (GSRH): a single item survey- self-administered single question such as "in general, would you say that your health is? excellent, very good, good, fair, or poor?", where excellent is scored as "5" and poor is scored as "0".'}, {'measure': 'Change from baseline secondary diabetes self-management behaviors', 'timeFrame': 'at 6 months', 'description': 'fifty-six-item survey. This includes a series of secondary diabetes self-management behaviors to explore mediating factors that might influence changes in glycemic control. We will assess the proportion of individuals with severe hypoglycemic episodes and use the brief modified Block seven-item diet screener with a four-week time horizon to determine the number of servings per day of fruit and vegetables.'}, {'measure': 'Change from baseline secondary diabetes self-management behaviors', 'timeFrame': 'at 12 months', 'description': 'fifty-six-item survey. This includes a series of secondary diabetes self-management behaviors to explore mediating factors that might influence changes in glycemic control. We will assess the proportion of individuals with severe hypoglycemic episodes and use the brief modified Block seven-item diet screener with a four-week time horizon to determine the number of servings per day of fruit and vegetables.'}, {'measure': 'Change from baseline self-efficacy in managing diabetes', 'timeFrame': 'at 6 months', 'description': 'This self-management resource center validated eight-item survey on patient confidence in performing certain activities. The survey is scored from 0 to 10 on a visual analog scale (VAS).'}, {'measure': 'Change from baseline self-efficacy in managing diabetes', 'timeFrame': 'at 12 months', 'description': 'This self-management resource center validated eight-item survey on patient confidence in performing certain activities. The survey is scored from 0 to 10 on a visual analog scale (VAS).'}, {'measure': 'Change from baseline diabetes distress', 'timeFrame': 'at 6 months', 'description': 'a two-item screening tool on 17 potential problems in the life of patients with diabetes. Patients are asked to score the distress ensuing from each problem during the last month from 1 to 6, where 1 is "Not a problem" and 6 is "a very serious problem".'}, {'measure': 'Change from baseline diabetes distress', 'timeFrame': 'at 12 months', 'description': 'a two-item screening tool on 17 potential problems in the life of patients with diabetes. Patients are asked to score the distress ensuing from each problem during the last month from 1 to 6, where 1 is "Not a problem" and 6 is "a very serious problem".'}, {'measure': 'Change from baseline medication Adherence', 'timeFrame': 'at 6 months', 'description': '"Morisky Green Levine" Medication Adherence Scale: a four-item tool queries about forgetfulness, carelessness, and feelings around taking medications, scored from 0 to 4.'}, {'measure': 'Change from baseline medication Adherence', 'timeFrame': 'at 12 months', 'description': '"Morisky Green Levine" Medication Adherence Scale: a four-item tool queries about forgetfulness, carelessness, and feelings around taking medications, scored from 0 to 4.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'To improve diabetes self-management outcomes, patients with type 2 diabetes (n=150 - aged 13-84) recruited from St. Vincent Clinic (SVC) and Teen Health Center Inc., Clinics will be randomized using block randomization to receive standard of care or the integrated model. Patients in the intervention arm will be assessed for social and physical needs before being enrolled in a year-long education program (iDSMES). Enrollees will receive dietary counseling, physical and occupational therapy, in addition to other mental, financial and social benefits counseling. The investigators will compare the intervention outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '84 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients aged 13-84, and\n2. Patients diagnosed with type 2 diabetes, and\n3. Patients have a BMI equal to or \\>25 (23, if Asians), and\n4. Hemoglobin A1c value equal to or \\>7%\n\nExclusion Criteria:\n\n1. Ages \\<13 or \\>84\n2. Pregnancy. If a subject becomes pregnant, they will advised to discontinue the study.\n3. Previous diagnosis of type 1 diabetes\n4. Inability to participate for 12-month duration (e.g., Disorders that might compromise survival, planning to relocate outside the geographical coverage of University of Texas Medical Branch (UTMB) clinics\n5. Other medical condition or medication administration deemed exclusionary by the study investigators\n6. Prisoners'}, 'identificationModule': {'nctId': 'NCT05097534', 'briefTitle': 'A Comprehensive Community Approach for Diabetes Prevention and Care for a Vulnerable Population in Galveston', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Medical Branch, Galveston'}, 'officialTitle': 'A Comprehensive Community Approach for Diabetes Prevention and Care for a Vulnerable Population in Galveston', 'orgStudyIdInfo': {'id': '21-0194'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'iDSMES', 'description': 'Eligible study subjects randomized to the intervention arm will receive:\n\nA. Intensive Diabetes Self-Management, Education, and Support (iDSMES). Participants will be enrolled in groups in a virtual or in-person setting with their lifestyle coach, in this one-year educational program B. Services addressing Social Determinants of Health All study subjects will have their data collected at time points around baseline, 6 months and 12 months from consenting including glycemic control, hypertension management, dyslipidemia management, prevention or management of complications, healthcare outcomes, lifestyle change outcomes, patient-centeredness outcomes, Secondary diabetes self-management behaviors, self-efficacy in managing diabetes, diabetes distress, and Morisky Green Levine Medication Adherence Scale.', 'interventionNames': ['Other: iDSMES']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Standard of Care', 'description': 'Eligible study subjects randomized to the intervention arm will receive standard of care offered to patients with diabetes.', 'interventionNames': ['Other: Standard of Care']}], 'interventions': [{'name': 'iDSMES', 'type': 'OTHER', 'description': 'Intensive Diabetes Self-Management Education and Support combined with Addressing Social Determinants of Health', 'armGroupLabels': ['iDSMES']}, {'name': 'Standard of Care', 'type': 'OTHER', 'description': 'Standard of Care for patients with type 2 diabetes', 'armGroupLabels': ['Standard of Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77550', 'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'facility': 'St. Vincent House Clinic', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Medical Branch, Galveston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}