Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-26 @ 12:23 AM
Study NCT ID:
NCT04922294
Status:
COMPLETED
Last Update Posted:
2022-12-20
First Post:
2021-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Implementation of a Cardiometabolic Disease Staging System in Primary Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}], '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'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-12-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-18', 'studyFirstSubmitDate': '2021-06-04', 'studyFirstSubmitQcDate': '2021-06-04', 'lastUpdatePostDateStruct': {'date': '2022-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Implementation preferences', 'timeFrame': 'Over one hour interviews or focus groups', 'description': 'Preferences for implementation and development of a cardiometabolic disease staging system for a clinical decision support system as identified by clinicians during qualitative focus groups'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Obesity', 'Overweight']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to develop a clinical decision support system (CDSS) that incorporates obesity management guidelines and treatment options for use by physicians and, potentially, patients based on a cardiometabolic disease staging system. This CDSS will be designed using primary care provider input through a qualitative approach to explore physician preferences for the appearance, electronic location, treatment options, referrals, accessibility and other user requirements of the CDSS.', 'detailedDescription': 'To provide appropriate medical management of obesity and facilitate the diabetes risk assessments of people with excess adiposity, a comprehensive staging system that establishes five stages of cardiometabolic disease risk-the cardiometabolic disease staging system (CMDS) has been developed. This staging is based on Adult Treatment Panel III metabolic syndrome risk factors to guide decision making for selection of treatment modality and intensity in the management of obesity. Hence, the study hypothesis is that providing CMDS to PCPs through a CDSS for medical management of obesity can aid in reducing the barriers of obesity and diabetes treatment at the PCP-level and improve the quality of obesity and diabetes care. In this pilot and feasibility study, investigators will implement an early-phase CDSS in a pragmatic PCP setting to assess the uptake and acceptability of CDSS delivered to PCPs implementing CMDS at the point of care, and collect pilot data to assess change in patient engagement and satisfaction.\n\nInvestigators will conduct initial focus groups with PCPs and a series of iterative design steps targeting PCP and patient needs. These qualitative interviews would be used to determine the initial set of requirements and prototypes of the user interfaces and notifications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Primary care physicians employed at the University of Alabama at Birmingham within the Primary Care or Family Medicine departments', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary care physicians employed at the University of Alabama at Birmingham\n\nExclusion Criteria:\n\n* Physicians ≥19'}, 'identificationModule': {'nctId': 'NCT04922294', 'briefTitle': 'Implementation of a Cardiometabolic Disease Staging System in Primary Care', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'Cardiometabolic Disease Staging System to Improve Medical Management of Obesity and Diabetes in Primary Care Settings', 'orgStudyIdInfo': {'id': 'IRB-300003559'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Clinical decision support system', 'type': 'OTHER', 'description': 'To develop a clinical decision support system based on a published cardiometabolic disease staging system.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}], 'overallOfficials': [{'name': 'Tapan S Mehta, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Associate Professor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Director of Research', 'investigatorFullName': 'Tapan Shirish Mehta', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}