Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2026-03-01 @ 12:51 PM
Study NCT ID:
NCT03159533
Status:
COMPLETED
Last Update Posted:
2020-05-18
First Post:
2017-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Project IMPACT: CHW Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Step wedge design, whereby 5 groups of 3 practices will implement the intervention in phases.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 305}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-15', 'studyFirstSubmitDate': '2017-04-13', 'studyFirstSubmitQcDate': '2017-05-17', 'lastUpdatePostDateStruct': {'date': '2020-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent of current diagnosed hypertensive patients with BP <140/90 (or BP<130/80 for patients with diabetes) at 6 Months', 'timeFrame': '6 Months'}, {'measure': 'Percent of current diagnosed hypertensive patients with BP <140/90 (or BP<130/80 for patients with diabetes) at 12 months', 'timeFrame': '12 months'}, {'measure': 'Percent of patients with HbA1c <7 (for patients with hypertension + diabetes) at 6 months', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Percent of patients with diagnosis of hypertension with a BP measure taken in the past 6 months', 'timeFrame': '6 months'}, {'measure': 'Percent of patients without hypertension having valid BP measurement, last 12 months', 'timeFrame': '12 months'}, {'measure': 'Percent of current hypertensive patients screened for diabetes in last year', 'timeFrame': '12 months'}, {'measure': 'Percent of current hypertensive patients receiving counseling on BMI, diet and physical activity', 'timeFrame': '12 months'}, {'measure': 'Percent of current diagnosed hypertensive patients referred to a nutritionist in the past year', 'timeFrame': '12 months'}, {'measure': 'Percent of current diagnosed hypertensive patients who smoke who have been referred for smoking cessation', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '36815464', 'type': 'DERIVED', 'citation': 'Islam NS, Wyatt LC, Ali SH, Zanowiak JM, Mohaimin S, Goldfeld K, Lopez P, Kumar R, Beane S, Thorpe LE, Trinh-Shevrin C. Integrating Community Health Workers into Community-Based Primary Care Practice Settings to Improve Blood Pressure Control Among South Asian Immigrants in New York City: Results from a Randomized Control Trial. Circ Cardiovasc Qual Outcomes. 2023 Mar;16(3):e009321. doi: 10.1161/CIRCOUTCOMES.122.009321. Epub 2023 Feb 23.'}, {'pmid': '29207983', 'type': 'DERIVED', 'citation': 'Lopez PM, Zanowiak J, Goldfeld K, Wyka K, Masoud A, Beane S, Kumar R, Laughlin P, Trinh-Shevrin C, Thorpe L, Islam N. Protocol for project IMPACT (improving millions hearts for provider and community transformation): a quasi-experimental evaluation of an integrated electronic health record and community health worker intervention study to improve hypertension management among South Asian patients. BMC Health Serv Res. 2017 Dec 6;17(1):810. doi: 10.1186/s12913-017-2767-1.'}]}, 'descriptionModule': {'briefSummary': 'The proposed study "Project IMPACT: CHW Intervention" is part of a larger study examining the efficacy, adoption, and impact of integrated EHR-based decision-support and physician feedback interventions with community health worker (CHW)-led self-management and coaching support for South Asian patients with uncontrolled hypertension. This is a randomized control intervention utilizing community health worker (CHW)-led self-management and coaching support for South Asian patients with uncontrolled hypertension at PCP clinics in New York City.', 'detailedDescription': 'The Goal of this study is that:\n\n1. EHR-based decision support and performance feedback interventions will be more effective in improving hypertension control for South Asian patients than standard care;\n2. A combined EHR-CHW intervention will be more effective in improving hypertension control for South Asian patients compared to standard care and the EHR-based intervention\n\nInvestigators hope to implement and assess the efficacy of CHW-led coaching through promotion of team-based care and use of culturally tailored education to improve hypertension control and mitigate risk factors related to CVD among South Asian patients with uncontrolled hypertension. Study findings can provide translatable and scalable models for other limited English proficient communities.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nCHW Intervention\n\n* Diagnosis of hypertension or at least two systolic blood pressure measurements of 140 mm Hg or greater, or at least two diastolic BP 90 mm Hg or greater in the past 12 months.\n\nFocus Group\n\n* Any clinical patients meeting the inclusion criteria for the CHW Intervention who participated in the CHW Intervention Pilot Round.\n\nExclusion Criteria:\n\n* Pregnant patients are excluded.\n* No children or vulnerable subjects will be enrolled in this study.'}, 'identificationModule': {'nctId': 'NCT03159533', 'acronym': 'IMPACT', 'briefTitle': 'Project IMPACT: CHW Intervention', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'Project IMPACT: Community Health Care Worker (CHW) Intervention', 'orgStudyIdInfo': {'id': '16-00969'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CHW Intervention', 'description': 'CHW lead Sessions Session1: BP and the Cardiovascular System Session 2: Nutrition and food labels Session 3: Physical Activity and Stress Management Session 4: CVD Risk factors: cholesterol, blood sugar, \\& Smoking Session 5: Health Communication, Healthcare access \\& Review', 'interventionNames': ['Behavioral: CHW Intervention']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group', 'description': 'Wait-list', 'interventionNames': ['Behavioral: Wait List Control Group']}], 'interventions': [{'name': 'CHW Intervention', 'type': 'BEHAVIORAL', 'description': 'Patients randomized to Group A will be invited to attend 4 more group educational sessions on self-management immediately.CHWs will follow up with participants by phone or in person through a home or clinic visit. At these follow-up meetings, CHWs will engage in goal-setting activities regarding changes to health behaviors, medication adherence, or other issues related to hypertension control as identified jointly by the patient and CHW. CHWs will also collect height, weight, and blood pressure measurements at initial and in-person follow-up visits. The CHW will make necessary referrals to other services available in the community (i.e. exercise classes, social services, mental health, tobacco cessation, etc.).', 'armGroupLabels': ['CHW Intervention']}, {'name': 'Wait List Control Group', 'type': 'BEHAVIORAL', 'description': '4 education sessions beginning 6-12 months later.', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Nadia Islam', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU Langone Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}