Ignite Creation Date:
2025-12-24 @ 1:16 PM
Ignite Modification Date:
2025-12-30 @ 8:58 AM
Study NCT ID:
NCT02549495
Status:
COMPLETED
Last Update Posted:
2025-12-22
First Post:
2015-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Impact of Community Health Workers on Adherence to Therapy for Non-Communicable Chronic Disease in Chiapas, Mexico
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dpalazuelos@bwh.harvard.edu', 'phone': '617-521-3381', 'title': 'Daniel Palazuelos, MD, MPH', 'organization': "Brigham and Women's Hospital"}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Through study completion, an average of 2 years', 'description': 'Study staff regularly monitored participants and kept an adverse event log that was reported to the IRB. Clinical events monitored include death, myocardial infarction, and stroke.', 'eventGroups': [{'id': 'EG000', 'title': 'Standard of Care', 'description': 'Patients with hypertension and/or diabetes across seven study communities prior to CHW intervention.', 'otherNumAtRisk': 149, 'deathsNumAtRisk': 149, 'otherNumAffected': 0, 'seriousNumAtRisk': 149, 'deathsNumAffected': 1, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'CHW Intervention', 'description': 'Patients with hypertension and/or diabetes across seven study communities following CHW intervention.', 'otherNumAtRisk': 149, 'deathsNumAtRisk': 149, 'otherNumAffected': 0, 'seriousNumAtRisk': 149, 'deathsNumAffected': 1, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Coronary Artery Disease', 'notes': 'Coronary artery disease would not be expected to result from standard of care or the intervention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stroke', 'notes': 'Stroke would not be expected to result from standard of care or the intervention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Hemoglobin A1c', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With Diabetes', 'description': 'Patients with diabetes included in the study'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.35', 'groupId': 'OG000', 'lowerLimit': '-0.90', 'upperLimit': '0.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 23 months', 'description': 'Change in percent glycated hemoglobin as measured by PTS diagnostics point-of-care assay', 'unitOfMeasure': 'percentage of glycated hemoglobin', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With Hypertension', 'description': 'Patients with hypertension included in the study'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.7', 'groupId': 'OG000', 'lowerLimit': '-8.9', 'upperLimit': '-0.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 23 months', 'description': 'Change in Systolic blood pressure as measured by Omron HEM 7080IT electronic blood pressure monitor', 'unitOfMeasure': 'mmHg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Adherence to Daily Medications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With Diabetes or Hypertension', 'description': 'All patients with diabetes and/or hypertension'}], 'timeFrame': 'One year after all communities receive intervention', 'description': 'Change in self-reported medication adherence as measured by 5-day recall, 30-day recall and response to Likert-style questions', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected for this measure and the outcome cannot be reported'}, {'type': 'SECONDARY', 'title': 'Change in Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With Hypertension', 'description': 'Patients with hypertension included in the study'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.2', 'groupId': 'OG000', 'lowerLimit': '-4.5', 'upperLimit': '0.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 23 months', 'description': 'Change in diastolic blood pressure as measured by Omron HEM 7080IT electronic blood pressure', 'unitOfMeasure': 'mmHg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Disease Control', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With Diabetes or Hypertension', 'description': 'All patients with diabetes and/or hypertension'}], 'timeFrame': 'One year after all communities receive intervention', 'description': 'Diabetes and/or hypertension control. Disease control among patients with hypertension was defined according to Mexican national guidelines: blood pressure \\<140/90 mm Hg for patients with hypertension and no diabetes; blood pressure \\<130/80 mm Hg for patients with hypertension and diabetes and blood pressure \\< 150/90 mm Hg for patients over the age of 80. Disease control for patients with diabetes defined as glycated hemoglobin (HbA1c) \\< 7% per national guidelines.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected and the outcome cannot be reported'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Patients With Diabetes or Hypertension', 'description': 'All patients in the seven study communities will receive the community health worker intervention provided by CES, as it is incorporated into the standard of care. However, they will receive the intervention at different points in time depending on which community they lived in, as community health worker programs can only be started at every-three-month intervals. Due to the stepped programmatic roll-out, the study mimics a stepped wedge cluster-randomized trial.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '168'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '127'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}]}], 'recruitmentDetails': 'Patients with diabetes, hypertension and respective risk factors were identified via a CES programme of clinic-based and door-to-door case finding.', 'preAssignmentDetails': 'Patients were excluded from participation after enrollment but prior to start of study if they were taken off treatment, we not actually on treatment, were enrolled after baseline data collection, moved outside study area, sought care in a different health system, or were found not to have diabetes and/or hypertension.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Patients With Diabetes or Hypertension', 'description': 'All patients in the seven study communities will receive the community health worker intervention provided by CES, as it is incorporated into the standard of care. However, they will receive the intervention at different points in time depending on which community they lived in, as community health worker programs can only be started at every-three-month intervals.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '107', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '42', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000', 'lowerLimit': '50', 'upperLimit': '71'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '96', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '53', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '149', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Mexico', 'categories': [{'measurements': [{'value': '149', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Has a radio', 'classes': [{'categories': [{'measurements': [{'value': '93', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Has a car/motorcycle', 'classes': [{'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Type of remuneration', 'classes': [{'title': 'Salary', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}, {'title': 'Day labour', 'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000'}]}]}, {'title': 'None', 'categories': [{'measurements': [{'value': '83', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Diabetes diagnosis', 'classes': [{'categories': [{'measurements': [{'value': '70', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hypertension diagnosis', 'classes': [{'categories': [{'measurements': [{'value': '110', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Systolic Blood Pressure', 'classes': [{'categories': [{'measurements': [{'value': '135', 'groupId': 'BG000', 'lowerLimit': '126', 'upperLimit': '151'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'HbA1c', 'classes': [{'categories': [{'measurements': [{'value': '9.3', 'groupId': 'BG000', 'lowerLimit': '7.2', 'upperLimit': '11.7'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'percent of glycosylated hemoglobin', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-07-31', 'size': 321726, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-06-15T16:54', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 168}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2019-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-04', 'studyFirstSubmitDate': '2015-04-17', 'resultsFirstSubmitDate': '2022-03-03', 'studyFirstSubmitQcDate': '2015-09-13', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-12-04', 'studyFirstPostDateStruct': {'date': '2015-09-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Hemoglobin A1c', 'timeFrame': 'Baseline, 23 months', 'description': 'Change in percent glycated hemoglobin as measured by PTS diagnostics point-of-care assay'}, {'measure': 'Change in Systolic Blood Pressure', 'timeFrame': 'Baseline, 23 months', 'description': 'Change in Systolic blood pressure as measured by Omron HEM 7080IT electronic blood pressure monitor'}], 'secondaryOutcomes': [{'measure': 'Change in Adherence to Daily Medications', 'timeFrame': 'One year after all communities receive intervention', 'description': 'Change in self-reported medication adherence as measured by 5-day recall, 30-day recall and response to Likert-style questions'}, {'measure': 'Change in Diastolic Blood Pressure', 'timeFrame': 'Baseline, 23 months', 'description': 'Change in diastolic blood pressure as measured by Omron HEM 7080IT electronic blood pressure'}, {'measure': 'Disease Control', 'timeFrame': 'One year after all communities receive intervention', 'description': 'Diabetes and/or hypertension control. Disease control among patients with hypertension was defined according to Mexican national guidelines: blood pressure \\<140/90 mm Hg for patients with hypertension and no diabetes; blood pressure \\<130/80 mm Hg for patients with hypertension and diabetes and blood pressure \\< 150/90 mm Hg for patients over the age of 80. Disease control for patients with diabetes defined as glycated hemoglobin (HbA1c) \\< 7% per national guidelines.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hypertension', 'Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '32152172', 'type': 'RESULT', 'citation': 'Worster DT, Franke MF, Bazua R, Flores H, Garcia Z, Krupp J, Maza J, Palazuelos L, Rodriguez K, Newman PM, Palazuelos D. Observational stepped-wedge analysis of a community health worker-led intervention for diabetes and hypertension in rural Mexico. BMJ Open. 2020 Mar 8;10(3):e034749. doi: 10.1136/bmjopen-2019-034749.'}, {'pmid': '29527344', 'type': 'RESULT', 'citation': 'Newman PM, Franke MF, Arrieta J, Carrasco H, Elliott P, Flores H, Friedman A, Graham S, Martinez L, Palazuelos L, Savage K, Tymeson H, Palazuelos D. Community health workers improve disease control and medication adherence among patients with diabetes and/or hypertension in Chiapas, Mexico: an observational stepped-wedge study. BMJ Glob Health. 2018 Feb 15;3(1):e000566. doi: 10.1136/bmjgh-2017-000566. eCollection 2018.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the effectiveness of community health workers when added to routine care for patients with diabetes and high blood pressure in rural clinics in Chiapas, Mexico. It does so by recording information on adherence to therapy, blood pressure and hemoglobin A1c while a non-governmental organization working in Mexico trains and introduces a community health worker program.', 'detailedDescription': 'Compañeros en Salud (CES), an affiliate project of Partners in Health, has been working in the rural Sierra of Chiapas, Mexico since February 2012. CES works in partnership with the local Ministry of Health to rehabilitate and staff existing government primary care clinics. Each community\'s clinic is staffed by one CES project physician year-round. CES activities span the range of allopathic medicine, but the focus of the project is in the prevention, detection, diagnosis and management of non-communicable diseases (NCDs) such as diabetes and hypertension. CES currently operates in several rural communities with catchment areas of approximately 1,500 - 2,500 people. Routine care for NCDs is based on national guidelines and consists of monthly in-clinic visits by primary care physicians.\n\nOver 9 months in 2014 and again over 6 months in 2016, CES will introduce a community health worker program called "Acompañantes" to its project communities to augment care of patients with NCDs. Acompañantes are lay health workers and members of the community who bridge the gap between project clinics and patients, improving understanding of NCDs, their treatments, and adherence to therapy. The introduction of Acompañantes to communities is planned in a once-every-three-months fashion, the most rapid roll-out logistically feasible for CES. The investigators\' project will document their experience over this time, and for one year after introduction of the Acompañantes program to all seven study communities, by documenting adherence to therapy, hemoglobin a1c, and blood pressure at every-three month intervals over this time frame.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with Diabetes Mellitus, Type 2, or Hypertension, taking daily therapy, living in one of seven study communities in rural Chiapas, Mexico.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Formal diagnosis of Type II Diabetes Mellitus, Stage I or II Hypertension or both\n* Daily medications required for patient's condition\n* Residence and receipt of therapy within the study catchment area\n* Age greater than or equal to 18 years.\n\nExclusion Criteria:\n\n* Known or suspected secondary hypertension\n* Known or suspected Type 1 diabetes\n* Pregnancy\n* Chronic use of glucocorticoids."}, 'identificationModule': {'nctId': 'NCT02549495', 'briefTitle': 'Impact of Community Health Workers on Adherence to Therapy for Non-Communicable Chronic Disease in Chiapas, Mexico', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'Evaluation of a Community Health Worker Intervention on Adherence to Therapy for Non-Communicable Chronic Disease in Chiapas, Mexico', 'orgStudyIdInfo': {'id': '2013P000711'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with Diabetes or Hypertension', 'description': 'All patients in the seven study communities will receive the community health worker intervention provided by CES, as it is incorporated into the standard of care. However, they will receive the intervention at different points in time depending on which community they lived in, as community health worker programs can only be started at every-three-month intervals'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02130', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Patrick M Newman, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': "Brigham and Women's Hospital"}, {'name': 'Daniel Palazuelos, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'Harvard University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Physician', 'investigatorFullName': 'Daniel Palazuelos', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}