Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-27 @ 11:58 PM
Study NCT ID:
NCT06121193
Status:
COMPLETED
Last Update Posted:
2023-11-09
First Post:
2023-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Using Interventional Informatics to Address Social Determinants of Health During Clinical Care Visits to Promote Behavior Change and PREVENT Cardiovascular Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2021-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-07', 'studyFirstSubmitDate': '2023-11-01', 'studyFirstSubmitQcDate': '2023-11-01', 'lastUpdatePostDateStruct': {'date': '2023-11-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Patients' satisfaction of PREVENT tool: survey", 'timeFrame': '3-months', 'description': "A survey (6-questions) will assess patient's satisfaction with the PREVENT tool. Questions are asked on a 5-point Likert scale (range: 6-30) with a higher score indicating greater satisfaction."}, {'measure': "Provider's satisfaction of PREVENT tool: survey", 'timeFrame': '3-months', 'description': "A survey (31-questions) will assess provider's acceptability and satisfaction with five aspects of health information technology: content, accuracy, format, ease of use and timeliness. Questions are asked on a 5-point Likert scale (range: 31-155) with a higher score indicating greater satisfaction."}, {'measure': 'Fidelity of PREVENT tool implementation', 'timeFrame': '0-3 months', 'description': 'Fidelity will be measured using direct observation of patient-provider interactions while using the PREVENT tool. A direct observation checklist will be used by the observer to determine the number of interactions with the PREVENT tool that were implemented as intended.'}], 'secondaryOutcomes': [{'measure': "Change in patient's motivation", 'timeFrame': 'At baseline, and 3-months', 'description': 'A survey (15-question) administered to patients will assess motivation and self-efficacy for behavior change. Questions are asked using a 4-point Likert scale (range: 15-60) with a higher score indicating greater motivation.'}, {'measure': "Change in patient's knowledge of CVH", 'timeFrame': 'At baseline, and 3-months', 'description': 'A survey (3-question) administered to patients to assess their knowledge of CVH risk (perceived value/importance of healthy behaviors) and awareness of resources. Questions are asked using a 4-point Likert scale (range: 3-12) with a higher score indicating greater knowledge.'}, {'measure': 'Change in food intake behaviors', 'timeFrame': 'At baseline, and 3-months', 'description': 'Patient-reported food intake behaviors (fruit and vegetable intake, whole grains, sugar-sweetened beverages and snacking behaviors) are collected using a brief Health Behavior \\& Attitudes Survey.'}, {'measure': 'Change in physical activity behaviors', 'timeFrame': 'At baseline, and 3-months', 'description': 'Patient-reported physical activity (minutes of moderate and vigorous activity per week) are collected using a survey (4-questions). Patients report the average number of minutes of moderate and vigorous activity they do per week.'}, {'measure': 'Change in body mass index z-score', 'timeFrame': 'At baseline, and 3-months', 'description': "Collected from patient's medical record. BMI z-score was calculated using the Centers for Disease Control and Prevention Growth Charts. The mean change was calculated by subtracting the baseline mean from the follow-up mean for each intervention group."}, {'measure': "Change on patient's average systolic and diastolic blood pressure", 'timeFrame': 'At baseline, and 3-months', 'description': "Collected from patient's medical record"}, {'measure': "Change in patient's cholesterol", 'timeFrame': 'At baseline, and 3-months', 'description': "Collected from patient's medical record"}, {'measure': "Change in patient's blood glucose", 'timeFrame': 'At baseline, and 3-months', 'description': "Collected from patient's medical record"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiovascular Diseases', 'Obesity']}, 'referencesModule': {'references': [{'pmid': '38758581', 'type': 'DERIVED', 'citation': 'Kepper M, Walsh-Bailey C, Miller ZM, Zhao M, Zucker K, Gacad A, Herrick C, White NH, Brownson RC, Foraker RE. The Impact of Behavior Change Counseling Delivered via a Digital Health Tool Versus Routine Care Among Adolescents With Obesity: Pilot Randomized Feasibility Study. JMIR Form Res. 2024 May 17;8:e55731. doi: 10.2196/55731.'}]}, 'descriptionModule': {'briefSummary': 'Healthcare providers recognize the need for behavior change and the influence of social determinants on youth at risk for poor cardiovascular health (CVH), especially among those of low-socioeconomic status (SES). Yet, providers lack the time and community data necessary to provide tailored, evidence-based care within routine practice. This project will use an Interventional Informatics approach to help providers prescribe patient-centered, evidence-based physical activity and nutrition prescriptions and link patients to community resources to account for social determinants at the point-of-care. This project will integrate our existing, novel, Patient-centered Real-timE interVENTion (PREVENT) tool into the BJC electronic health record (EHR) and test it with providers and adolescent patients at-risk for poor CVH. EHR integration of PREVENT will enable a cyclical, synergistic and data-centric approach to impact modifiable risk factors (physical activity and food intake) and prevent cardiovascular disease. This approach uses health informatics technology (HIT) to deliver data-driven, patient-centered care and generate evidence to support the use of HIT as a way to prevent cardiovascular disease across diverse patients and communities.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 12-17 years at baseline\n* at risk for poor CVH (body mass index \\>= 85th percentile)\n* Receiving care from the Healthy Start Clinic at Barnes Jewish Hospital.'}, 'identificationModule': {'nctId': 'NCT06121193', 'briefTitle': 'Using Interventional Informatics to Address Social Determinants of Health During Clinical Care Visits to Promote Behavior Change and PREVENT Cardiovascular Disease', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Using Interventional Informatics to Address Social Determinants of Health During Clinical Care Visits to Promote Behavior Change and PREVENT Cardiovascular Disease', 'orgStudyIdInfo': {'id': '202004230'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Patients - Wait-List Control', 'description': 'Complete questionnaires at baseline (administered electronically or by mail). Follow-up measures will be administered at 3-months after the clinic visit electronically and by mail.\n\n• A PREVENT action plan (behavior change prescription, community resources, and education) will be provided to the patient via email after the completion of the follow-up measurement.', 'interventionNames': ['Behavioral: Wait-list Control']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental: Patients - PREVENT Tool', 'description': 'Complete questionnaires at baseline (administered electronically or by mail). Follow-up measures will be administered immediately following the clinic visit, and monthly for 3-months after the clinic visit electronically and by mail\n\n• At the clinic visit, the provider will use the PREVENT tool to discuss CVH risk and deliver a tailored behavioral change plan inclusive of patient-centered community resources.', 'interventionNames': ['Behavioral: PREVENT tool']}, {'type': 'NO_INTERVENTION', 'label': 'Providers', 'description': '-All eligible providers will be sent questionnaires electronically to their email at baseline, following provider training and follow-up. Providers will be invited to attend a training session to educate them on the PREVENT tool at baseline.'}], 'interventions': [{'name': 'PREVENT tool', 'type': 'BEHAVIORAL', 'description': 'PREVENT is a novel Health Information Technology tool designed to promote physical activity and healthy food intake among overweight/obese patients at the point of care. PREVENT automates the delivery of personalized, evidence-based behavior change recommendations and provides an interactive map of community resources to help providers link patients to resources in their community.', 'armGroupLabels': ['Experimental: Patients - PREVENT Tool']}, {'name': 'Wait-list Control', 'type': 'BEHAVIORAL', 'description': 'Will receive routine clinical care. After completion of follow-up measures, control participants will receive a behavior change prescription via the PREVENT tool', 'armGroupLabels': ['Patients - Wait-List Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63130', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University in St. Louis', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}