Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2025-12-25 @ 8:43 PM
Study NCT ID:
NCT05965869
Status:
RECRUITING
Last Update Posted:
2025-11-21
First Post:
2023-07-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Healthy Communities Through CHW Initiatives
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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-06-30', 'size': 313993, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-06-30T07:11', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2028-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2023-07-20', 'studyFirstSubmitQcDate': '2023-07-20', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the integration of the intervention', 'timeFrame': '6-months', 'description': 'CHW ability to use software as measured by the number of anticipated vs. actual documents uploaded at 6-months'}], 'secondaryOutcomes': [{'measure': 'Provide acceptability data of the intervention', 'timeFrame': '6-months', 'description': 'Site, CHW, and participant survey data at 6-months as measured on a Likert scale, e.g., Likert scale from 1 to 5 where 1 is unsatisfied and 5 is very satisfied.\n\nParticipant participation trends in the intervention'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2', 'Diabetes Mellitus Risk']}, 'referencesModule': {'references': [{'pmid': '36273386', 'type': 'BACKGROUND', 'citation': 'Wyatt LC, Katigbak C, Riley L, Zanowiak JM, Ursua R, Kwon SC, Trinh-Shevrin C, Islam NS. Promoting Physical Activity Among Immigrant Asian Americans: Results from Four Community Health Worker Studies. J Immigr Minor Health. 2023 Apr;25(2):291-305. doi: 10.1007/s10903-022-01411-y. Epub 2022 Oct 23.'}, {'pmid': '36205473', 'type': 'BACKGROUND', 'citation': 'Hessler D, Fisher L, Dickinson M, Dickinson P, Parra J, Potter MB. The impact of enhancing self-management support for diabetes in Community Health Centers through patient engagement and relationship building: a primary care pragmatic cluster-randomized trial. Transl Behav Med. 2022 Oct 7;12(9):909-918. doi: 10.1093/tbm/ibac046.'}, {'pmid': '36222807', 'type': 'BACKGROUND', 'citation': 'Levy NK, Park A, Solis D, Hu L, Langford AT, Wang B, Rogers ES. Social Determinants of Health and Diabetes-Related Distress in Patients With Insulin-Dependent Type 2 Diabetes: Cross-sectional, Mixed Methods Approach. JMIR Form Res. 2022 Oct 12;6(10):e40164. doi: 10.2196/40164.'}, {'pmid': '36307274', 'type': 'BACKGROUND', 'citation': 'Wagner J, Bermudez-Millan A, Buckley T, Buxton OM, Feinn R, Kong S, Kuoch T, Nye LM, Scully M. Self-reported outcomes of a randomized trial comparing three community health worker interventions for diabetes prevention among Cambodian Americans with depression. Patient Educ Couns. 2022 Dec;105(12):3501-3508. doi: 10.1016/j.pec.2022.09.011. Epub 2022 Oct 6.'}, {'pmid': '36192769', 'type': 'BACKGROUND', 'citation': 'Deverts DJ, Heisler M, Kieffer EC, Piatt GA, Valbuena F, Yabes JG, Guajardo C, Ilarraza-Montalvo D, Palmisano G, Koerbel G, Rosland AM. Comparing the effectiveness of Family Support for Health Action (FAM-ACT) with traditional community health worker-led interventions to improve adult diabetes management and outcomes: study protocol for a randomized controlled trial. Trials. 2022 Oct 3;23(1):841. doi: 10.1186/s13063-022-06764-1.'}, {'pmid': '10259963', 'type': 'BACKGROUND', 'citation': 'Attkisson CC, Zwick R. The client satisfaction questionnaire. Psychometric properties and correlations with service utilization and psychotherapy outcome. Eval Program Plann. 1982;5(3):233-7. doi: 10.1016/0149-7189(82)90074-x.'}, {'pmid': '32932865', 'type': 'BACKGROUND', 'citation': 'Keegan CN, Johnston CA, Cardenas VJ Jr, Vaughan EM. Evaluating the Impact of Telehealth-Based, Diabetes Medication Training for Community Health Workers on Glycemic Control. J Pers Med. 2020 Sep 11;10(3):121. doi: 10.3390/jpm10030121.'}, {'pmid': '11194219', 'type': 'BACKGROUND', 'citation': 'Garcia AA, Villagomez ET, Brown SA, Kouzekanani K, Hanis CL. The Starr County Diabetes Education Study: development of the Spanish-language diabetes knowledge questionnaire. Diabetes Care. 2001 Jan;24(1):16-21. doi: 10.2337/diacare.24.1.16.'}, {'pmid': '16627519', 'type': 'BACKGROUND', 'citation': 'Dumville JC, Torgerson DJ, Hewitt CE. Reporting attrition in randomised controlled trials. BMJ. 2006 Apr 22;332(7547):969-71. doi: 10.1136/bmj.332.7547.969.'}, {'pmid': '27563386', 'type': 'BACKGROUND', 'citation': 'Parmanto B, Lewis AN Jr, Graham KM, Bertolet MH. Development of the Telehealth Usability Questionnaire (TUQ). Int J Telerehabil. 2016 Jul 1;8(1):3-10. doi: 10.5195/ijt.2016.6196. eCollection 2016 Spring.'}, {'pmid': '25361792', 'type': 'BACKGROUND', 'citation': 'Belone L, Lucero JE, Duran B, Tafoya G, Baker EA, Chan D, Chang C, Greene-Moton E, Kelley MA, Wallerstein N. Community-Based Participatory Research Conceptual Model: Community Partner Consultation and Face Validity. Qual Health Res. 2016 Jan;26(1):117-35. doi: 10.1177/1049732314557084. Epub 2014 Oct 31.'}, {'pmid': '36316145', 'type': 'BACKGROUND', 'citation': 'Rimawi A, Shah A, Louis H, Scales D, Kheiran JA, Jawabreh N, Yunez S, Horino M, Seita A, Wispelwey B. Community Health Worker Program Outcomes for Diabetes and Hypertension Control in West Bank Refugee Camps: A Retrospective Matched Cohort Study. Glob Health Sci Pract. 2022 Oct 31;10(5):e2200168. doi: 10.9745/GHSP-D-22-00168. Print 2022 Oct 31.'}, {'pmid': '35132555', 'type': 'BACKGROUND', 'citation': 'Vaughan EM, Johnson E, Naik AD, Amspoker AB, Balasubramanyam A, Virani SS, Ballantyne CM, Johnston CA, Foreyt JP. Long-Term Effectiveness of the TIME Intervention to Improve Diabetes Outcomes in Low-Income Settings: a 2-Year Follow-Up. J Gen Intern Med. 2022 Sep;37(12):3062-3069. doi: 10.1007/s11606-021-07363-7. Epub 2022 Feb 7.'}, {'pmid': '34385148', 'type': 'BACKGROUND', 'citation': 'Vaughan EM, Naik AD, Amspoker AB, Johnston CA, Landrum JD, Balasubramanyam A, Virani SS, Ballantyne CM, Foreyt JP. Mentored implementation to initiate a diabetes program in an underserved community: a pilot study. BMJ Open Diabetes Res Care. 2021 Aug;9(1):e002320. doi: 10.1136/bmjdrc-2021-002320.'}]}, 'descriptionModule': {'briefSummary': 'Latino(a)s suffer from poor social determinants of health (SODH) conditions more than non-minority populations, and being a minority is risk factor alone for diabetes. In the proposed study, investigators will assist church members in becoming Community Health Workers (CHWs), train them in diabetes, and to track the ability to address healthcare access and quality barriers using an online platform.', 'detailedDescription': 'Social determinants of health (SODH) are environmental variables that determine quality-of-life outcomes and risks that are delineated into five domains. Inequities in SODH are directly associated with diabetes. Latino(a)s suffer from poor SODH conditions more than non-minority populations, and being a minority is risk factor alone for diabetes. To quantify progress in SODH, Healthy People 2030 has provided specific objectives to measure each domain (economic stability, education access and quality, healthcare access and quality, neighborhood and build environment, and social and community context); this application focuses on the healthcare access and quality domain. While there are numerous screening mechanisms to identify SODH conditions, there is a critical need to implement interventions that are translatable into real-world practices.\n\nA successful intervention requires several components. For the community, sites are needed that can bring individuals together, making collaboration with faith-based establishments of particular interest. Religious institutions provide an infrastructure that will persist beyond funding periods and a framework for the community to share a responsibility of health promotion. Churches also provide an accessible and familiar setting to provide health outreach programs but often lack trained personnel to conduct initiatives. In addition, training leaders within these settings who can reach the community is essential. Community Health Workers (CHWs) are trusted leaders within their community. Training church members to become CHWs potentially establishes a site familiar to the surrounding communities led by trusted individuals who understand the population at hand. Finally, secure avenues to collect and transmit data are needed. Utilizing secure HIPAA-approved technology reduces risks of loss of confidentiality while allowing collection of valuable information that may not have been collected otherwise. Since COVID-19, investigators have increased the use of online platforms, but these modalities must be translatable to personnel with potentially little to no technological experience.\n\nTo address gaps in SDOH, the investigators propose a 6-month church-based intervention for Latino(a)s with and at risk for diabetes (n=460) in a two phase study, pilot followed by main study. We will assist church members in becoming CHWs, train them in diabetes, and use an online platform to track the ability to address healthcare access and quality barriers. The research team will provide telementoring to local community teams (church leadership and CHWs) to initiate the intervention. We will test the feasibility of the program using three pre-established areas of focus: acceptability, integration, limited efficacy testing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Spanish-speaking Latino(a)s adults\n\nExclusion Criteria:\n\n* pregnant state or anticipated state in the next 6 months\n* Type 1 diabetes diagnosis\n* Not geographically located to reach church site/attend classes\n* Not Spanish-speaking, and\n* Self-disclosed diagnosis of schizophrenia, psychotic/delusional disorder, or severe Alzheimer's disease."}, 'identificationModule': {'nctId': 'NCT05965869', 'briefTitle': 'Healthy Communities Through CHW Initiatives', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Medical Branch, Galveston'}, 'officialTitle': 'Creating Healthy Communities Through a Church-based, Community Health Worker-led Initiative', 'orgStudyIdInfo': {'id': '23-0169'}, 'secondaryIdInfos': [{'id': '23-0169', 'type': 'OTHER', 'domain': 'University of Texas Medical Branch, Galveston IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diabetes program and education', 'description': 'Receive diabetes program and education', 'interventionNames': ['Other: diabetes program']}], 'interventions': [{'name': 'diabetes program', 'type': 'OTHER', 'description': 'CHWs will contact participants weekly via phone or text, send bimonthly diabetes education videos, and provide optional monthly seminars.', 'armGroupLabels': ['Diabetes program and education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77555-0158', 'city': 'Galveston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Erika LeGross', 'role': 'CONTACT', 'phone': '409-266-9400'}], 'facility': 'University of Texas Medical Branch at Galveston', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}], 'centralContacts': [{'name': 'Elizabeth Vaughan, DO', 'role': 'CONTACT', 'email': 'emvaugha316@gmail.com', 'phone': '1-409-772-4182'}, {'name': 'Valeria Lescano', 'role': 'CONTACT', 'email': 'valescan@utmb.edu'}], 'overallOfficials': [{'name': 'Elizabeth Vaughan, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas Medical Branch, Galveston'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Medical Branch, Galveston', 'class': 'OTHER'}, 'collaborators': [{'name': 'Baylor College of Medicine', 'class': 'OTHER'}, {'name': 'University of Houston', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}