Ignite Creation Date:
2025-12-24 @ 11:47 PM
Ignite Modification Date:
2025-12-25 @ 9:40 PM
Study NCT ID:
NCT06080451
Status:
COMPLETED
Last Update Posted:
2025-06-19
First Post:
2023-10-06
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Implementing HEARTS in Guatemala
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], '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'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006354', 'term': 'Heart, Artificial'}], 'ancestors': [{'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D001187', 'term': 'Artificial Organs'}, {'id': 'D013523', 'term': 'Surgical Equipment'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dcflood@umich.edu', 'phone': '734-647-2892', 'title': 'Dr. David Flood', 'organization': 'University of Michigan'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 months', 'description': 'Providers were asked to provide patient adverse event information to the Michigan team when they occurred. No reports were sent.\n\nNo adverse event data collection was planned for the provider arm.', 'eventGroups': [{'id': 'EG000', 'title': 'HEARTS Implementation - Patients', 'description': 'A trial for 6 months will be carried out in 11 Ministry of Health primary care facilities starting in October 2023. This arm consists of the patients whose health markers will be monitored through the study.\n\nIntegrated Diabetes and Hypertension Primary Care Model: The intervention consists of five components that align with the World Health Organization Technical Package for Cardiovascular Disease Management in primary Health Care.\n\n1. Training health workers on diabetes and hypertension treatment protocols\n2. Team-based care and task sharing\n3. Strengthening access to medications and diagnostics\n4. Electronic medical record system and registry\n5. Systems monitoring and feedback of key indicators', 'otherNumAtRisk': 964, 'deathsNumAtRisk': 964, 'otherNumAffected': 0, 'seriousNumAtRisk': 964, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'HEARTS Implementation - Providers', 'description': 'A trial for 6 months will be carried out in 11 Ministry of Health primary care facilities starting in October 2023. This arm consists of the health care providers who will be administering care to the patient participants.\n\nIntegrated Diabetes and Hypertension Primary Care Model - Providers: The intervention consists of five components that align with the World Health Organization Technical Package for Cardiovascular Disease Management in primary Health Care.\n\n1. Training health workers on diabetes and hypertension treatment protocols\n2. Team-based care and task sharing\n3. Strengthening access to medications and diagnostics\n4. Electronic medical record system and registry\n5. Systems monitoring and feedback of key indicators\n\nHealth care providers will administer this intervention to patient participants and will report on their experience.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Score on Feasibility of Intervention Measure (FIM) Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HEARTS Implementation - Providers', 'description': 'A trial for 6 months will be carried out in 11 Ministry of Health primary care facilities starting in October 2023. This arm consists of the health care providers who will be administering care to the patient participants.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000', 'lowerLimit': '5.0', 'upperLimit': '5.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'description': 'Feasibility will be assessed among Ministry of Health (MOH) participants through the four-item Feasibility of Intervention Measure (FIM) Questionnaire and semi-structured interviews. A Spanish-language version of the FIM will be adapted for this project. Scores will be on a scale of 1 to 5, with 1 being the worst and 5 being the best. The average score for each participant will be used.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure only applies to the Providers group. No data was collected for the Patients group. Only 20 providers responded to this survey.'}, {'type': 'PRIMARY', 'title': 'Number of Target Health Districts That Met Enrollment Goals', 'denoms': [{'units': 'Participants', 'counts': [{'value': '964', 'groupId': 'OG000'}]}, {'units': 'Districts', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HEARTS Implementation - Patients', 'description': 'A trial for 6 months will be carried out in 11 Ministry of Health primary care facilities starting in October 2023. This arm consists of the patients whose health markers will be monitored through the study.\n\nIntegrated Diabetes and Hypertension Primary Care Model: The intervention consists of five components that align with the World Health Organization Technical Package for Cardiovascular Disease Management in primary Health Care.\n\n1. Training health workers on diabetes and hypertension treatment protocols\n2. Team-based care and task sharing\n3. Strengthening access to medications and diagnostics\n4. Electronic medical record system and registry\n5. Systems monitoring and feedback of key indicators'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': '6 months', 'description': 'This study will be working with two different health districts, one in the west and the other in the east. This measure is the number of districts that met enrollment goals for patients for patients with diabetes (at least 25) and also for patients with hypertension (at least 25). A given patient may have both diabetes and hypertension and thus count toward each benchmark', 'unitOfMeasure': 'Districts', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Districts', 'denomUnitsSelected': 'Districts', 'populationDescription': 'This outcome measure only applies to the Patients group. No data was collected for the Providers group.'}, {'type': 'PRIMARY', 'title': 'Score on Acceptability of Intervention Measure (AIM) Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HEARTS Implementation - Providers', 'description': 'A trial for 6 months will be carried out in 11 Ministry of Health primary care facilities starting in October 2023. This arm consists of the health care providers who will be administering care to the patient participants.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000', 'lowerLimit': '4.8', 'upperLimit': '5.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'description': 'Acceptability will be assessed among providers through the four-item Acceptability Intervention Measure (AIM) Questionnaire and semi-structured interviews. A Spanish-language version of the AIM will be adapted for this project. Scores will be on a scale of 1 to 5, with 1 being the worst and 5 being the best. The average score for each participant will be used.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 20 providers responded to this survey. This measure only applies to the provider arm.'}, {'type': 'PRIMARY', 'title': 'Proportion of Patient Participants With Subsequent Follow-up Visit Within 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '964', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HEARTS Implementation - Patients', 'description': 'A trial for 6 months will be carried out in 11 Ministry of Health primary care facilities starting in October 2023. This arm consists of the patients whose health markers will be monitored through the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 months', 'description': 'Proportion of patient participants with subsequent follow-up visit within 3 months in both regions combined.', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hypertension Treatment Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '964', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HEARTS Implementation - Patients', 'description': 'A trial for 6 months will be carried out in 11 Ministry of Health primary care facilities starting in October 2023. This arm consists of the patients whose health markers will be monitored through the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '197', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Number of patients receiving hypertension medication treatment in the 6th month of the study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Diabetes Treatment Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '964', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HEARTS Implementation - Patients', 'description': 'A trial for 6 months will be carried out in 11 Ministry of Health primary care facilities starting in October 2023. This arm consists of the patients whose health markers will be monitored through the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '108', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Number of patients receiving diabetes medication treatment in the 6th month of the trial..', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Proportion of Patient Participants Achieving Glycemic Control', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HEARTS Implementation - Patients', 'description': 'A trial for 6 months will be carried out in 11 Ministry of Health primary care facilities starting in October 2023. This arm consists of the patients whose health markers will be monitored through the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Proportion achieving glycemic control (fasting blood glucose \\<115 mg/dl or random blood glucose \\<160 mg/dl) among patients with diabetes', 'unitOfMeasure': 'percent', 'reportingStatus': 'POSTED', 'populationDescription': 'Monitoring system only captured data from 39 participants and failed to capture data for other participants'}, {'type': 'SECONDARY', 'title': 'Proportion Achieving Control of Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HEARTS Implementation - Patients', 'description': 'A trial for 6 months will be carried out in 11 Ministry of Health primary care facilities starting in October 2023. This arm consists of the patients whose health markers will be monitored through the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '50.6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Proportion achieving control of blood pressure (\\<130/80 mmHg) among patients with hypertension. This information will be taken from electronic medical records.', 'unitOfMeasure': 'percent', 'reportingStatus': 'POSTED', 'populationDescription': 'The monitoring system was incompletely utilized and only captured this data for 83 participants'}, {'type': 'SECONDARY', 'title': 'Adoption', 'denoms': [{'units': 'Participants', 'counts': [{'value': '964', 'groupId': 'OG000'}]}, {'units': 'Clinics', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HEARTS Implementation - Patients', 'description': 'A trial for 6 months will be carried out in 11 Ministry of Health primary care facilities starting in October 2023. This arm consists of the patients whose health markers will be monitored through the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': '6 months', 'description': 'Count and percentage of participating health facilities who enrolled at least one patient with hypertension or diabetes.', 'unitOfMeasure': 'Clinics', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Clinics', 'denomUnitsSelected': 'Clinics', 'populationDescription': 'One of the eleven initially planned health facilities declined to participate in the study.'}, {'type': 'SECONDARY', 'title': 'Fidelity - Health Worker Training', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HEARTS Implementation - Providers', 'description': 'A trial for 6 months will be carried out in 11 Ministry of Health primary care facilities starting in October 2023. This arm consists of the health care providers who will be administering care to the patient participants.'}], 'classes': [{'title': 'District 1', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': 'District 2', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Number of health workers in each district attending all training sessions', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Fidelity - Team-based Care and Task Sharing', 'denoms': [{'units': 'Participants', 'counts': [{'value': 'NA', 'groupId': 'OG000'}]}, {'units': 'Clinics', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HEARTS Implementation - Clinics', 'description': 'A trial for 6 months will be carried out in 11 Ministry of Health primary care facilities starting in October 2023. This group consists of the clinics at which the patient participants will be receiving care from the provider participants.'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': '6 months', 'description': 'Proportion of primary health facilities conducting at least one care coordination meeting', 'unitOfMeasure': 'Clinics', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Clinics', 'denomUnitsSelected': 'Clinics', 'populationDescription': 'This group is of Clinics, not of participants. One of the eleven initially planned facilities declined to participate in this study.'}, {'type': 'SECONDARY', 'title': 'Fidelity - Access to Medicines and Diagnostics', 'denoms': [{'units': 'Participants', 'counts': [{'value': 'NA', 'groupId': 'OG000'}]}, {'units': 'Clinics', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HEARTS Implementation - Clinics', 'description': 'A trial for 6 months will be carried out in 11 Ministry of Health primary care facilities starting in October 2023. This arm consists of the clinics at which the patient participants received care from the provider participants.'}], 'classes': [{'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Months in which primary health facilities had monthly availability of Ministry of Health medications and diagnostics for diabetes and hypertension. Drugs include antihypertensive medications (hydrochlorothiazide, enalapril, losartan) and oral hypoglycemic agents (metformin and glimepiride). Diagnostics including blood pressure cuffs and monitors, glucometers, lancets, and glucose strips.\n\nData is reported in "clinic-months", which is the sum number of months that each clinic reported monthly availability of medications and diagnostics (n=60 total clinic months(10 clinics x 6 months)).', 'unitOfMeasure': 'clinic-months', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Clinics', 'denomUnitsSelected': 'Clinics', 'populationDescription': 'One of the eleven initially planned facilities declined to participate in this study.'}, {'type': 'SECONDARY', 'title': 'Fidelity - Facility-based Electronic Monitoring Tool', 'denoms': [{'units': 'Participants', 'counts': [{'value': '964', 'groupId': 'OG000'}]}, {'units': 'Visits', 'counts': [{'value': '1374', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HEARTS Implementation - Patients', 'description': 'A trial for 6 months will be carried out in 11 Ministry of Health primary care facilities starting in October 2023. This arm consists of the patients whose health markers will be monitored through the study.\n\nIntegrated Diabetes and Hypertension Primary Care Model: The intervention consists of five components that align with the World Health Organization Technical Package for Cardiovascular Disease Management in primary Health Care.\n\n1. Training health workers on diabetes and hypertension treatment protocols\n2. Team-based care and task sharing\n3. Strengthening access to medications and diagnostics\n4. Electronic medical record system and registry\n5. Systems monitoring and feedback of key indicators'}], 'classes': [{'categories': [{'measurements': [{'value': '7.6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': "Proportion of patient visits captured in DHIS2 during the study compared to comprehensive records in the Ministry of Health's Health Management Information System. Data was collected at the end of the 6th month study. Data is presented as percent of visits that were captured.", 'unitOfMeasure': 'percentage of visits', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Visits', 'denomUnitsSelected': 'Visits', 'populationDescription': 'Number of patient visits'}, {'type': 'SECONDARY', 'title': 'Usability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HEARTS Implementation - Providers', 'description': 'A trial for 6 months will be carried out in 11 Ministry of Health primary care facilities starting in October 2023. This arm consists of the health care providers who will be administering care to the patient participants.'}], 'classes': [{'categories': [{'measurements': [{'value': '67.7', 'spread': '23.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Average score on the System Usability Scale questionnaire. Scores have a range of 0 (worst) to 100 (best). Questionnaire was given to the provider arm only.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Questionnaire was given to the provider arm only. 20 of the 40 providers responded to this survey.'}, {'type': 'SECONDARY', 'title': 'Sustainability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HEARTS Implementation - Providers', 'description': 'A trial for 6 months will be carried out in 11 Ministry of Health primary care facilities starting in October 2023. This arm consists of the health care providers who will be administering care to the patient participants.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG000', 'lowerLimit': '4.8', 'upperLimit': '5.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'description': 'Mean score on a sustainability questionnaire. Questionnaire was created by combining 6 questions from the Program Sustainability Assessment Tool (PSAT) and Clinical Sustainability Assessment Tools (CSAT). Scores range from 1 (worst) to 7 (best). The data reported is the median of the mean scores for each of the health providers.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': '20 of the 40 provider participants responded to this survey.'}, {'type': 'SECONDARY', 'title': 'Mean Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HEARTS Implementation - Patients', 'description': 'A trial for 6 months will be carried out in 11 Ministry of Health primary care facilities starting in October 2023. This arm consists of the patients whose health markers will be monitored through the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '141.7', 'spread': '18.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Mean systolic blood pressure among patients with hypertension', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "While this outcome measure was part of the original plan for the study, implementation of monitoring this outcome failed and data was only collected for 72 patients. This outcome measure did not apply to the provider's arm."}, {'type': 'SECONDARY', 'title': 'Mean Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HEARTS Implementation - Patients', 'description': 'A trial for 6 months will be carried out in 11 Ministry of Health primary care facilities starting in October 2023. This arm consists of the patients whose health markers will be monitored through the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '81.5', 'spread': '11.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 Months', 'description': 'Mean diastolic blood pressure among patients with hypertension', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "While this outcome measure was part of the original plan for the study, implementation of monitoring this outcome failed and data was only collected for 71 patients. This outcome measure did not apply to the provider's arm. While Systolic pressure was recorded for 72 participants, diastolic pressure was not recorded from one of these participants due to an unknown error at the clinic."}, {'type': 'SECONDARY', 'title': 'Fidelity - Chart Audit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HEARTS Implementation - Patients', 'description': 'A trial for 6 months will be carried out in 11 Ministry of Health primary care facilities starting in October 2023. This arm consists of the patients whose health markers will be monitored through the study.'}], 'timeFrame': '6 months', 'description': "Proportion of clinical visits that are guideline concordant according to study team's audit of least 25% of patient visits", 'reportingStatus': 'POSTED', 'populationDescription': "While this outcome measure was part of the original plan for the study, implementation of monitoring this outcome failed and no data was collected due to physicians' declination to use the software. This measure only applied to the patients arm."}, {'type': 'SECONDARY', 'title': 'Fidelity - Systems Monitoring and Feedback', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HEARTS Implementation - Patients', 'description': 'A trial for 6 months will be carried out in 11 Ministry of Health primary care facilities starting in October 2023. This arm consists of the patients whose health markers will be monitored through the study.'}, {'id': 'OG001', 'title': 'HEARTS Implementation - Providers', 'description': 'A trial for 6 months will be carried out in 11 Ministry of Health primary care facilities starting in October 2023. This arm consists of the health care providers who will be administering care to the patient participants.'}], 'timeFrame': '6 months', 'description': 'Proportion of quarterly reports viewed by health district administrators', 'reportingStatus': 'POSTED', 'populationDescription': "While this outcome measure was part of the original plan for the study, implementation of monitoring this outcome failed and no data was collected due to physicians' declination to use the software."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'HEARTS Implementation - Patients', 'description': 'A trial for 6 months will be carried out in 11 Ministry of Health primary care facilities starting in October 2023. This arm consists of the patients whose health markers will be monitored through the study.'}, {'id': 'FG001', 'title': 'HEARTS Implementation - Providers', 'description': 'A trial for 6 months will be carried out in 11 Ministry of Health primary care facilities starting in October 2023. This arm consists of the health care providers who will be administering care to the patient participants.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '964'}, {'comment': 'Providers trained on the intervention', 'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'Completed Provider Survey (Not Applicable to Patient Arm)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '964'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '20'}]}]}], 'preAssignmentDetails': 'Providers not considered Enrolled'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '964', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '984', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'HEARTS Implementation - Patients', 'description': 'A trial for 6 months will be carried out in 11 Ministry of Health primary care facilities starting in October 2023. This arm consists of the patients whose health markers will be monitored through the study.\n\nIntegrated Diabetes and Hypertension Primary Care Model: The intervention consists of five components that align with the World Health Organization Technical Package for Cardiovascular Disease Management in primary Health Care.\n\n1. Training health workers on diabetes and hypertension treatment protocols\n2. Team-based care and task sharing\n3. Strengthening access to medications and diagnostics\n4. Electronic medical record system and registry\n5. Systems monitoring and feedback of key indicators'}, {'id': 'BG001', 'title': 'HEARTS Implementation - Providers', 'description': 'A trial for 6 months will be carried out in 11 Ministry of Health primary care facilities starting in October 2023. This arm consists of the health care providers who will be administering care to the patient participants.\n\nIntegrated Diabetes and Hypertension Primary Care Model - Providers: The intervention consists of five components that align with the World Health Organization Technical Package for Cardiovascular Disease Management in primary Health Care.\n\n1. Training health workers on diabetes and hypertension treatment protocols\n2. Team-based care and task sharing\n3. Strengthening access to medications and diagnostics\n4. Electronic medical record system and registry\n5. Systems monitoring and feedback of key indicators\n\nHealth care providers will administer this intervention to patient participants and will report on their experience.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '964', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '964', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '55.2', 'groupId': 'BG000', 'lowerLimit': '44.1', 'upperLimit': '66.1'}, {'value': '55.2', 'groupId': 'BG002', 'lowerLimit': '44.1', 'upperLimit': '66.1'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'Age data was only collected for the patient arm and not for the provider arm.'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '964', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '964', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '760', 'groupId': 'BG000'}, {'value': '760', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '204', 'groupId': 'BG000'}, {'value': '204', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Sex data was only collected for the patient arm and not for the provider arm.'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '964', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '964', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '474', 'groupId': 'BG000'}, {'value': '474', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '486', 'groupId': 'BG000'}, {'value': '486', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Ethnicity data was only collected for the patient arm and not for the provider arm.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Guatemala', 'denoms': [{'units': 'Participants', 'counts': [{'value': '964', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '984', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '964', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '984', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-09-15', 'size': 1233489, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-03-24T13:52', 'hasProtocol': True}, {'date': '2023-08-11', 'size': 126545, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-02-25T16:34', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 964}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-05-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-17', 'studyFirstSubmitDate': '2023-10-06', 'resultsFirstSubmitDate': '2025-02-26', 'studyFirstSubmitQcDate': '2023-10-06', 'lastUpdatePostDateStruct': {'date': '2025-06-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-06-17', 'studyFirstPostDateStruct': {'date': '2023-10-12', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-06-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Score on Feasibility of Intervention Measure (FIM) Questionnaire', 'timeFrame': '6 months', 'description': 'Feasibility will be assessed among Ministry of Health (MOH) participants through the four-item Feasibility of Intervention Measure (FIM) Questionnaire and semi-structured interviews. A Spanish-language version of the FIM will be adapted for this project. Scores will be on a scale of 1 to 5, with 1 being the worst and 5 being the best. The average score for each participant will be used.'}, {'measure': 'Number of Target Health Districts That Met Enrollment Goals', 'timeFrame': '6 months', 'description': 'This study will be working with two different health districts, one in the west and the other in the east. This measure is the number of districts that met enrollment goals for patients for patients with diabetes (at least 25) and also for patients with hypertension (at least 25). A given patient may have both diabetes and hypertension and thus count toward each benchmark'}, {'measure': 'Score on Acceptability of Intervention Measure (AIM) Questionnaire', 'timeFrame': '6 months', 'description': 'Acceptability will be assessed among providers through the four-item Acceptability Intervention Measure (AIM) Questionnaire and semi-structured interviews. A Spanish-language version of the AIM will be adapted for this project. Scores will be on a scale of 1 to 5, with 1 being the worst and 5 being the best. The average score for each participant will be used.'}, {'measure': 'Proportion of Patient Participants With Subsequent Follow-up Visit Within 3 Months', 'timeFrame': '3 months', 'description': 'Proportion of patient participants with subsequent follow-up visit within 3 months in both regions combined.'}], 'secondaryOutcomes': [{'measure': 'Hypertension Treatment Rate', 'timeFrame': '6 months', 'description': 'Number of patients receiving hypertension medication treatment in the 6th month of the study.'}, {'measure': 'Diabetes Treatment Rate', 'timeFrame': '6 months', 'description': 'Number of patients receiving diabetes medication treatment in the 6th month of the trial..'}, {'measure': 'Proportion of Patient Participants Achieving Glycemic Control', 'timeFrame': '6 months', 'description': 'Proportion achieving glycemic control (fasting blood glucose \\<115 mg/dl or random blood glucose \\<160 mg/dl) among patients with diabetes'}, {'measure': 'Proportion Achieving Control of Blood Pressure', 'timeFrame': '6 months', 'description': 'Proportion achieving control of blood pressure (\\<130/80 mmHg) among patients with hypertension. This information will be taken from electronic medical records.'}, {'measure': 'Adoption', 'timeFrame': '6 months', 'description': 'Count and percentage of participating health facilities who enrolled at least one patient with hypertension or diabetes.'}, {'measure': 'Fidelity - Health Worker Training', 'timeFrame': '6 months', 'description': 'Number of health workers in each district attending all training sessions'}, {'measure': 'Fidelity - Team-based Care and Task Sharing', 'timeFrame': '6 months', 'description': 'Proportion of primary health facilities conducting at least one care coordination meeting'}, {'measure': 'Fidelity - Access to Medicines and Diagnostics', 'timeFrame': '6 months', 'description': 'Months in which primary health facilities had monthly availability of Ministry of Health medications and diagnostics for diabetes and hypertension. Drugs include antihypertensive medications (hydrochlorothiazide, enalapril, losartan) and oral hypoglycemic agents (metformin and glimepiride). Diagnostics including blood pressure cuffs and monitors, glucometers, lancets, and glucose strips.\n\nData is reported in "clinic-months", which is the sum number of months that each clinic reported monthly availability of medications and diagnostics (n=60 total clinic months(10 clinics x 6 months)).'}, {'measure': 'Fidelity - Facility-based Electronic Monitoring Tool', 'timeFrame': '6 months', 'description': "Proportion of patient visits captured in DHIS2 during the study compared to comprehensive records in the Ministry of Health's Health Management Information System. Data was collected at the end of the 6th month study. Data is presented as percent of visits that were captured."}, {'measure': 'Usability', 'timeFrame': '6 months', 'description': 'Average score on the System Usability Scale questionnaire. Scores have a range of 0 (worst) to 100 (best). Questionnaire was given to the provider arm only.'}, {'measure': 'Sustainability', 'timeFrame': '6 months', 'description': 'Mean score on a sustainability questionnaire. Questionnaire was created by combining 6 questions from the Program Sustainability Assessment Tool (PSAT) and Clinical Sustainability Assessment Tools (CSAT). Scores range from 1 (worst) to 7 (best). The data reported is the median of the mean scores for each of the health providers.'}, {'measure': 'Mean Systolic Blood Pressure', 'timeFrame': '6 months', 'description': 'Mean systolic blood pressure among patients with hypertension'}, {'measure': 'Mean Diastolic Blood Pressure', 'timeFrame': '6 Months', 'description': 'Mean diastolic blood pressure among patients with hypertension'}, {'measure': 'Fidelity - Chart Audit', 'timeFrame': '6 months', 'description': "Proportion of clinical visits that are guideline concordant according to study team's audit of least 25% of patient visits"}, {'measure': 'Fidelity - Systems Monitoring and Feedback', 'timeFrame': '6 months', 'description': 'Proportion of quarterly reports viewed by health district administrators'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2', 'Hypertension', 'Cardiovascular Diseases']}, 'referencesModule': {'references': [{'pmid': '38195600', 'type': 'BACKGROUND', 'citation': "Wellmann IA, Ayala LF, Rodriguez JJ, Guetterman TC, Irazola V, Palacios E, Huffman MD, Rohloff P, Heisler M, Ramirez-Zea M, Flood D. Implementing integrated hypertension and diabetes management using the World Health Organization's HEARTS model: protocol for a pilot study in the Guatemalan national primary care system. Implement Sci Commun. 2024 Jan 9;5(1):7. doi: 10.1186/s43058-023-00539-8."}, {'pmid': '39896314', 'type': 'RESULT', 'citation': "Wellmann IA, Ayala LF, Valley TM, Irazola V, Huffman MD, Heisler M, Rohloff P, Donis R, Palacios E, Ramirez-Zea M, Flood D. Evaluating the World Health Organization's Hearts Model for Hypertension and Diabetes Management: A Pilot Implementation Study in Guatemala. Glob Heart. 2025 Jan 31;20(1):9. doi: 10.5334/gh.1397. eCollection 2025."}]}, 'descriptionModule': {'briefSummary': 'The HEARTS Technical Package was developed by the World Health Organization to address the implementation gap of cardiovascular disease prevention in low- and middle-income countries. Guatemala is a middle-income country that is currently implementing HEARTS. National authorities are interested in exploring how hypertension and diabetes management can be integrated in HEARTS implementation. The objective of this study is to conduct a feasibility and acceptability pilot trial of integrated hypertension and diabetes management based on HEARTS in the publicly funded primary care system in Guatemala.', 'detailedDescription': 'A single-arm pilot trial for 6 months will be carried out in 11 Ministry of Health primary care facilities starting in September 2023. A planned sample of 100 adult patients diagnosed with diabetes (n=45), hypertension (n=45), or both (n=10) will be enrolled. The intervention will consist of HEARTS-aligned components: Training health workers on Healthy-lifestyle counseling and Evidence-based treatment protocols; strengthening Access to medications and diagnostics; training on Risk-based cardiovascular disease management; Team-based care and task sharing; and Systems monitoring and feedback, including implementation of a facility-based electronic monitoring tool at the individual level. Co-primary outcomes of feasibility and acceptability will be assessed using an explanatory sequential mixed methods design. Secondary outcomes include clinical effectiveness (treatment with medication, glycemic control, and blood pressure control) and key implementation outcomes (adoption, fidelity, usability, and sustainability).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Patient participants\n\nInclusion criteria:\n\n* Non-pregnant adults aged ≥18 years\n* Diagnoses of type 2 diabetes or hypertension\n* Present for routine care at participating MOH primary health facilities\n\nExclusion criteria:\n\n* Confirmed or suspected type 1 diabetes\n* Pregnant\n* Are not managed at MOH health centers or health posts\n\nProvider/other participants\n\nInclusion criteria:\n\n• Participation in delivering HEARTS or on the Technical Advisory Committee\n\nExclusion criteria:\n\n• None'}, 'identificationModule': {'nctId': 'NCT06080451', 'briefTitle': 'Implementing HEARTS in Guatemala', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Implementing Integrated Diabetes and Hypertension Management in Guatemala Using the HEARTS Model', 'orgStudyIdInfo': {'id': 'HUM00234613'}, 'secondaryIdInfos': [{'id': 'K23HL161271', 'link': 'https://reporter.nih.gov/quickSearch/K23HL161271', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HEARTS implementation - Patients', 'description': 'A trial for 6 months will be carried out in 11 Ministry of Health primary care facilities starting in October 2023. This arm consists of the patients whose health markers will be monitored through the study.', 'interventionNames': ['Other: Integrated Diabetes and Hypertension Primary Care Model']}, {'type': 'EXPERIMENTAL', 'label': 'HEARTS implementation - Providers', 'description': 'A trial for 6 months will be carried out in 11 Ministry of Health primary care facilities starting in October 2023. This arm consists of the health care providers who will be administering care to the patient participants.', 'interventionNames': ['Other: Integrated Diabetes and Hypertension Primary Care Model - Providers']}], 'interventions': [{'name': 'Integrated Diabetes and Hypertension Primary Care Model', 'type': 'OTHER', 'otherNames': ['HEARTS'], 'description': 'The intervention consists of five components that align with the World Health Organization Technical Package for Cardiovascular Disease Management in primary Health Care.\n\n1. Training health workers on diabetes and hypertension treatment protocols\n2. Team-based care and task sharing\n3. Strengthening access to medications and diagnostics\n4. Electronic medical record system and registry\n5. Systems monitoring and feedback of key indicators', 'armGroupLabels': ['HEARTS implementation - Patients']}, {'name': 'Integrated Diabetes and Hypertension Primary Care Model - Providers', 'type': 'OTHER', 'description': 'The intervention consists of five components that align with the World Health Organization Technical Package for Cardiovascular Disease Management in primary Health Care.\n\n1. Training health workers on diabetes and hypertension treatment protocols\n2. Team-based care and task sharing\n3. Strengthening access to medications and diagnostics\n4. Electronic medical record system and registry\n5. Systems monitoring and feedback of key indicators\n\nHealth care providers will administer this intervention to patient participants and will report on their experience.', 'armGroupLabels': ['HEARTS implementation - Providers']}]}, 'contactsLocationsModule': {'locations': [{'city': 'San Pablo La Laguna', 'state': 'Departamento de Sololá', 'country': 'Guatemala', 'facility': 'Ministry of Health clinics', 'geoPoint': {'lat': 14.72092, 'lon': -91.27242}}], 'overallOfficials': [{'name': 'David Flood, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'ipdSharing': 'YES', 'description': "This project will produce multiple types of data, including patients' clinical information, health facility assessments, and structured and semi-structured interviews. Deidentified data, analytic code, and data dictionaries will be made available on the NHLBI Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC) data repository (https://biolincc.nhlbi.nih.gov/) after the study concludes. Semi-structured interview transcripts and structured questionnaire data will not be shared due to privacy concerns and risk for re-identification."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}, {'name': 'Institute of Nutrition of Central America and Panama', 'class': 'OTHER'}, {'name': 'Ministry of Health, Guatemala', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Medicine', 'investigatorFullName': 'David Flood', 'investigatorAffiliation': 'University of Michigan'}}}}