Implementation Support for HEARTS-Based Hypertension and Diabetes Care in Guatemala (MULTI-HEARTS)
Cluster-Randomized Trial of Implementation Support for HEARTS-Based Care Among Adults With Hypertension and Diabetes in Guatemala (MULTI-HEARTS)
The purpose of this study is to find out whether extra support for a program called HEARTS can improve care for people who have both high blood pressure and diabetes. HEARTS was created by the World Health Organization to help primary care health centers deliver better treatment. It is the official model for high blood pressure and diabetes care in Guatemala's Ministry of Health. In this study, 36 Ministry of Health health centers in Guatemala will be randomly assigned to 1 of 2 groups. Health centers in both groups will use HEARTS through the Ministry of Health's routine training, treatment guides, and digital tools. Health centers in 1 group will also receive 36 months of extra support from the Institute of Nutrition of Central America and Panama (INCAP). This support includes refresher training for health workers every 6 months, monthly supportive supervision visits, and coaching of a health center quality committee to use data to improve care. About 1,440 adults who have both high blood pressure and diabetes will take part. Participants will be assessed at the start of the study, at 6 months, and at 12 months. The main measure is systolic blood pressure at 12 months. The most important other measure is hemoglobin A1c (a blood test that shows average blood sugar levels over the past 2 to 3 months) at 12 months.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
MULTI-HEARTS is a cluster-randomized, hybrid type 2 effectiveness-implementation trial of implementation support for HEARTS, the official model for hypertension and diabetes primary care in Guatemala's Ministry of Health. Health centers in both arms will implement HEARTS through the Ministry of Health's routine strategies. In the implementation support arm, health centers also will receive additional implementation support strategies directed at health workers, managers, and support staff.
The primary objective is to evaluate whether HEARTS implementation support leads to better hypertension and diabetes control than routine HEARTS implementation among adults with hypertension and diabetes. We hypothesize that implementation support will lead to lower mean systolic blood pressure at 12 months (primary outcome) compared to routine HEARTS implementation. The key secondary outcome is mean hemoglobin A1c (HbA1c) at 12 months. Other secondary outcomes are mean diastolic blood pressure and the proportions of participants with blood pressure control, HbA1c control, and combined blood pressure and HbA1c control at 12 months. The primary implementation outcome is Reach, which is defined in the study to be the monthly number of patients treated with both antihypertensive and glucose-lowering medications at participating health centers. In an economic evaluation, we will also estimate costs, cost-effectiveness, and budget impact.
We will randomize 36 Ministry of Health health centers in a 1:1 ratio, with stratification by health area. We will enroll 1,440 adults aged 18 years or older with systolic blood pressure ≥130 mmHg and HbA1c ≥6.5%. There will be approximately 40 participants per health center and a total of 720 per arm. Allowing for 15% attrition, the trial will have at least 80% power to detect a between-arm difference of 5.0 mmHg in mean systolic blood pressure at 12 months. The health centers serve urban and rural communities, and many participants will live in poverty and have limited literacy. Some trial participants are expected to be Indigenous Maya and will primarily speak a Mayan language rather than Spanish.
After a 1-year trial planning period, health centers will be randomized before the start of the 36-month implementation period. Each participant will be followed for 12 months. Ministry of Health administrative data will also be collected for a 6-month post-trial period. In addition to the trial data, the study includes additional data collection for implementation and economic evaluations.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: David Flood, MD
- Número de teléfono: 734-647-2892
- Correo electrónico: dcflood@umich.edu
Copia de seguridad de contactos de estudio
- Nombre: Peter Rohloff, MD, PhD
- Número de teléfono: 617-732-5500
- Correo electrónico: prohloff@mgb.org
Ubicaciones de estudio
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Guatemala City, Guatemala
- Ministry of Health health centers
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Contacto:
- Chronic Disease Program, Ministry of Health
- Número de teléfono: +502 2444-7474
- Correo electrónico: cronicas.dnpap@mspas.gob.gt
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Age 18 years or older.
- Blood pressure criteria, defined as mean systolic blood pressure of ≥130 mmHg at the screening visit and again at the enrollment visit, held 1 to 14 days apart.
- Glycemic criteria, defined as one of the following: (a) for individuals with a prior diagnosis of diabetes or currently taking a glucose-lowering drug, HbA1c of ≥6.5% at the screening visit; (b) for individuals without a prior diagnosis of diabetes and not taking a glucose-lowering drug, HbA1c of ≥6.5% at both the screening and enrollment visits.
- Living in a community served by one of the health centers included in the study and willing to receive health care at the corresponding health center.
- Provides informed consent in Spanish or the main Mayan language in the municipality where they live.
Exclusion Criteria:
- Pregnant or planning pregnancy during the 12-month follow-up period, based on self-report.
- Type 1 diabetes, based on self-reported medical history or the judgment of the study physician.
- Illness that, in the judgment of the study physician, limits life expectancy to less than 12 months or would prevent completion of study follow-up, including but not limited to end-stage kidney disease requiring or awaiting dialysis, advanced heart failure, liver failure, or cancer under active treatment.
- Currently participating in another research study involving an intervention.
- Planning to leave the community served by the health center during the 12-month follow-up period.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Implementation support arm
Routine HEARTS implementation with additional implementation support from INCAP for 36 months. |
Group refresher training every 6 months, monthly supportive supervision visits, and data-driven coaching of a health center quality committee, delivered by INCAP implementation support physicians to health workers, managers, and support staff. An initial training-of-trainers workshop, Clinical Pathways for hypertension and type 2 diabetes, and digital tools, delivered by the Ministry of Health under its National Strategy for Cardio-Reno-Metabolic Risk Management based on HEARTS. |
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Comparador activo: Routine implementation arm
Routine HEARTS implementation alone. |
An initial training-of-trainers workshop, Clinical Pathways for hypertension and type 2 diabetes, and digital tools, delivered by the Ministry of Health under its National Strategy for Cardio-Reno-Metabolic Risk Management based on HEARTS. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Systolic blood pressure
Periodo de tiempo: 12 months after the enrollment visit
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Between-arm mean difference in systolic blood pressure, using the mean of 3 automated readings. |
12 months after the enrollment visit
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Hemoglobin A1c
Periodo de tiempo: 12 months after the enrollment visit
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Key secondary outcome. Between-arm mean difference in hemoglobin A1c, measured with a point-of-care device. |
12 months after the enrollment visit
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Diastolic blood pressure
Periodo de tiempo: 12 months after the enrollment visit
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Between-arm mean difference in diastolic blood pressure, using the mean of 3 automated readings. |
12 months after the enrollment visit
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Proportion of participants with blood pressure control
Periodo de tiempo: 12 months after the enrollment visit
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Between-arm difference in the proportion of participants with blood pressure control of <130/<80 mmHg, as defined in national guidelines. |
12 months after the enrollment visit
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Proportion of participants with hemoglobin A1c control
Periodo de tiempo: 12 months after the enrollment visit
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Between-arm difference in the proportion of participants with hemoglobin A1c control of <7.0%, as defined in national guidelines. |
12 months after the enrollment visit
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Proportion of participants with combined blood pressure control and hemoglobin A1c control
Periodo de tiempo: 12 months after the enrollment visit
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Between-arm difference in the proportion of participants with combined blood pressure control (<130/<80 mmHg) and hemoglobin A1c control (<7.0%), as defined in national guidelines. |
12 months after the enrollment visit
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: David Flood, MD, MSc, University of Michigan
- Investigador principal: Peter Rohloff, MD, PhD, Brigham and Women's Hospital
- Investigador principal: Manuel Ramírez-Zea, MD, PhD, Institute of Nutrition of Central America and Panama
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- HUM00301585
- R61HL183254 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
We will deposit de-identified participant-level data collected at study visits in a data repository selected in accordance with NHLBI policy.
Marco de tiempo para compartir IPD
No later than the time of an associated publication or the end of the performance period, whichever comes first.
Criterios de acceso compartido de IPD
The repository will control access to the data in accordance with NHLBI policy.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
Información sobre medicamentos y dispositivos, documentos del estudio
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