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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: David Flood, MD
- Telefoonnummer: 734-647-2892
- E-mail: dcflood@umich.edu
Studie Contact Back-up
- Naam: Peter Rohloff, MD, PhD
- Telefoonnummer: 617-732-5500
- E-mail: prohloff@mgb.org
Studie Locaties
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Guatemala City, Guatemala
- Ministry of Health health centers
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Contact:
- Chronic Disease Program, Ministry of Health
- Telefoonnummer: +502 2444-7474
- E-mail: cronicas.dnpap@mspas.gob.gt
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Onderzoek naar gezondheidsdiensten
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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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Actieve vergelijker: 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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Systolic blood pressure
Tijdsspanne: 12 months after the enrollment visit
|
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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Hemoglobin A1c
Tijdsspanne: 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
Tijdsspanne: 12 months after the enrollment visit
|
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
Tijdsspanne: 12 months after the enrollment visit
|
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
Tijdsspanne: 12 months after the enrollment visit
|
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
Tijdsspanne: 12 months after the enrollment visit
|
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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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: David Flood, MD, MSc, University of Michigan
- Hoofdonderzoeker: Peter Rohloff, MD, PhD, Brigham and Women's Hospital
- Hoofdonderzoeker: Manuel Ramírez-Zea, MD, PhD, Institute of Nutrition of Central America and Panama
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- HUM00301585
- R61HL183254 (Subsidie/contract van de Amerikaanse NIH)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
We will deposit de-identified participant-level data collected at study visits in a data repository selected in accordance with NHLBI policy.
IPD-tijdsbestek voor delen
No later than the time of an associated publication or the end of the performance period, whichever comes first.
IPD-toegangscriteria voor delen
The repository will control access to the data in accordance with NHLBI policy.
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
- ICF
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