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| ID | Type | Description | Link |
|---|---|---|---|
| K23HL161271 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| Institute of Nutrition of Central America and Panama | OTHER |
| Ministry of Health, Guatemala | OTHER_GOV |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HEARTS implementation - Patients | Experimental | 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. |
|
| HEARTS implementation - Providers | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Integrated Diabetes and Hypertension Primary Care Model | Other | The intervention consists of five components that align with the World Health Organization Technical Package for Cardiovascular Disease Management in primary Health Care.
|
| Measure | Description | Time Frame |
|---|---|---|
| Score on Feasibility of Intervention Measure (FIM) Questionnaire | 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. | 6 months |
| Number of Target Health Districts That Met Enrollment Goals | 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 | 6 months |
| Score on Acceptability of Intervention Measure (AIM) Questionnaire | 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. | 6 months |
| Proportion of Patient Participants With Subsequent Follow-up Visit Within 3 Months | Proportion of patient participants with subsequent follow-up visit within 3 months in both regions combined. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Hypertension Treatment Rate | Number of patients receiving hypertension medication treatment in the 6th month of the study. | 6 months |
| Diabetes Treatment Rate | Number of patients receiving diabetes medication treatment in the 6th month of the trial.. |
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Patient participants
Inclusion criteria:
Exclusion criteria:
Provider/other participants
Inclusion criteria:
• Participation in delivering HEARTS or on the Technical Advisory Committee
Exclusion criteria:
• None
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| Name | Affiliation | Role |
|---|---|---|
| David Flood, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ministry of Health clinics | San Pablo La Laguna | Departamento de Sololá | Guatemala |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38195600 | Background | 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. | |
| 39896314 | Result | 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. |
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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.
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Providers not considered Enrolled
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| ID | Title | Description |
|---|---|---|
| FG000 | HEARTS Implementation - Patients | 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. |
| FG001 | HEARTS Implementation - Providers | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | HEARTS Implementation - Patients | 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. Integrated 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.
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age data was only collected for the patient arm and not for the provider arm. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Score on Feasibility of Intervention Measure (FIM) Questionnaire | 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. | This outcome measure only applies to the Providers group. No data was collected for the Patients group. Only 20 providers responded to this survey. | Posted | Median | Inter-Quartile Range | score on a scale | 6 months |
|
6 months
Providers were asked to provide patient adverse event information to the Michigan team when they occurred. No reports were sent.
No adverse event data collection was planned for the provider arm.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HEARTS Implementation - Patients | 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. Integrated 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.
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Flood | University of Michigan | 734-647-2892 | dcflood@umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 15, 2023 | Mar 24, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 11, 2023 | Feb 25, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D006973 | Hypertension |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D006354 | Heart, Artificial |
| ID | Term |
|---|---|
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
| D001187 | Artificial Organs |
| D013523 | Surgical Equipment |
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|
|
| Integrated Diabetes and Hypertension Primary Care Model - Providers | Other | The intervention consists of five components that align with the World Health Organization Technical Package for Cardiovascular Disease Management in primary Health Care.
Health care providers will administer this intervention to patient participants and will report on their experience. |
|
| 6 months |
| Proportion of Patient Participants Achieving Glycemic Control | Proportion achieving glycemic control (fasting blood glucose <115 mg/dl or random blood glucose <160 mg/dl) among patients with diabetes | 6 months |
| Proportion Achieving Control of Blood Pressure | Proportion achieving control of blood pressure (<130/80 mmHg) among patients with hypertension. This information will be taken from electronic medical records. | 6 months |
| Adoption | Count and percentage of participating health facilities who enrolled at least one patient with hypertension or diabetes. | 6 months |
| Fidelity - Health Worker Training | Number of health workers in each district attending all training sessions | 6 months |
| Fidelity - Team-based Care and Task Sharing | Proportion of primary health facilities conducting at least one care coordination meeting | 6 months |
| Fidelity - Access to Medicines and Diagnostics | 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. Data 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)). | 6 months |
| Fidelity - Facility-based Electronic Monitoring Tool | 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. | 6 months |
| Usability | 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. | 6 months |
| Sustainability | 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. | 6 months |
| Mean Systolic Blood Pressure | Mean systolic blood pressure among patients with hypertension | 6 months |
| Mean Diastolic Blood Pressure | Mean diastolic blood pressure among patients with hypertension | 6 Months |
| Fidelity - Chart Audit | Proportion of clinical visits that are guideline concordant according to study team's audit of least 25% of patient visits | 6 months |
| Fidelity - Systems Monitoring and Feedback | Proportion of quarterly reports viewed by health district administrators | 6 months |
| 42145591 | Derived | Valley TM, Santizo-Malafronti C, Wellmann IA, Ayala LF, Lucas N, Huffman MD, Chary A, Rohloff P, Donis R, Nufio AIAA, Ramirez-Zea M, Flood D. Understanding implementation of HEARTS for hypertension and diabetes in Guatemala: Qualitative and mixed-methods pilot results. medRxiv [Preprint]. 2026 May 6:2026.05.04.26352395. doi: 10.64898/2026.05.04.26352395. |
| BG001 | HEARTS Implementation - Providers | 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. Integrated 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.
Health care providers will administer this intervention to patient participants and will report on their experience. |
| BG002 | Total | Total of all reporting groups |
| Median |
| Inter-Quartile Range |
| years |
|
| Sex: Female, Male | Sex data was only collected for the patient arm and not for the provider arm. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Ethnicity data was only collected for the patient arm and not for the provider arm. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Number of Target Health Districts That Met Enrollment Goals | 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 | This outcome measure only applies to the Patients group. No data was collected for the Providers group. | Posted | Count of Units | Districts | 6 months | Districts | Districts |
|
|
|
| Primary | Score on Acceptability of Intervention Measure (AIM) Questionnaire | 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. | Only 20 providers responded to this survey. This measure only applies to the provider arm. | Posted | Median | Inter-Quartile Range | score on a scale | 6 months |
|
|
|
| Primary | Proportion of Patient Participants With Subsequent Follow-up Visit Within 3 Months | Proportion of patient participants with subsequent follow-up visit within 3 months in both regions combined. | Posted | Number | percentage of patients | 3 months |
|
|
|
| Secondary | Hypertension Treatment Rate | Number of patients receiving hypertension medication treatment in the 6th month of the study. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | Diabetes Treatment Rate | Number of patients receiving diabetes medication treatment in the 6th month of the trial.. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | Proportion of Patient Participants Achieving Glycemic Control | Proportion achieving glycemic control (fasting blood glucose <115 mg/dl or random blood glucose <160 mg/dl) among patients with diabetes | Monitoring system only captured data from 39 participants and failed to capture data for other participants | Posted | Number | percent | 6 months |
|
|
|
| Secondary | Proportion Achieving Control of Blood Pressure | Proportion achieving control of blood pressure (<130/80 mmHg) among patients with hypertension. This information will be taken from electronic medical records. | The monitoring system was incompletely utilized and only captured this data for 83 participants | Posted | Number | percent | 6 months |
|
|
|
| Secondary | Adoption | Count and percentage of participating health facilities who enrolled at least one patient with hypertension or diabetes. | One of the eleven initially planned health facilities declined to participate in the study. | Posted | Count of Units | Clinics | 6 months | Clinics | Clinics |
|
|
|
| Secondary | Fidelity - Health Worker Training | Number of health workers in each district attending all training sessions | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | Fidelity - Team-based Care and Task Sharing | Proportion of primary health facilities conducting at least one care coordination meeting | This group is of Clinics, not of participants. One of the eleven initially planned facilities declined to participate in this study. | Posted | Count of Units | Clinics | 6 months | Clinics | Clinics |
|
|
|
| Secondary | Fidelity - Access to Medicines and Diagnostics | 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. Data 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)). | One of the eleven initially planned facilities declined to participate in this study. | Posted | Number | clinic-months | 6 months | Clinics | Clinics |
|
|
|
| Secondary | Fidelity - Facility-based Electronic Monitoring Tool | 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. | Number of patient visits | Posted | Number | percentage of visits | 6 months | Visits | Visits |
|
|
|
| Secondary | Usability | 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. | Questionnaire was given to the provider arm only. 20 of the 40 providers responded to this survey. | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
|
|
| Secondary | Sustainability | 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. | 20 of the 40 provider participants responded to this survey. | Posted | Median | Inter-Quartile Range | units on a scale | 6 months |
|
|
|
| Secondary | Mean Systolic Blood Pressure | Mean systolic blood pressure among patients with hypertension | 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. | Posted | Mean | Standard Deviation | mmHg | 6 months |
|
|
|
| Secondary | Mean Diastolic Blood Pressure | Mean diastolic blood pressure among patients with hypertension | 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. | Posted | Mean | Standard Deviation | mmHg | 6 Months |
|
|
|
| Secondary | Fidelity - Chart Audit | Proportion of clinical visits that are guideline concordant according to study team's audit of least 25% of patient visits | 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. | Posted | 6 months |
|
|
| Secondary | Fidelity - Systems Monitoring and Feedback | Proportion of quarterly reports viewed by health district administrators | 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. | Posted | 6 months |
|
|
| 0 |
| 964 |
| 0 |
| 964 |
| 0 |
| 964 |
| EG001 | HEARTS Implementation - Providers | 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. Integrated 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.
Health care providers will administer this intervention to patient participants and will report on their experience. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D004700 | Endocrine System Diseases |
| D014652 | Vascular Diseases |
| Unknown or Not Reported |
|