Multicomponent Intervention to Improve Hypertension Control in Central America

Implementing a Multicomponent Intervention to Improve Hypertension Control in Central America

The investigators propose to assess the needs, barriers, and knowledge gaps of hypertension control programs in the national health care systems of the Central America 4 region LMIC (CA-4: Guatemala, Honduras, El Salvador, and Nicaragua); to conduct a cluster randomized trial to test the effect of a multilevel and multicomponent intervention program leveraging an existing subnational primary healthcare system in Guatemala, on blood pressure (BP) control among hypertensive patients; and to evaluate the adaptability, feasibility, fidelity, and sustainability of implementing the program in the primary health care systems of the CA-4 region. The comprehensive intervention, which includes protocol-based treatment using a standard BP management algorithm, team-based collaborative care, BP audit and feedback, home BP monitoring, and health coaching on antihypertensive medication adherence and lifestyle modification, will last for 18 months. This implementation research study presents high public health impact because it will generate urgently needed data on effective, practical, and sustainable intervention strategies aimed at reducing BP related disease burden in Central America and other low- and middle-income countries.

Study Overview

• Status: Completed
• Conditions: Arterial Hypertension
• Intervention / Treatment: Other: Multicomponent intervention

Detailed Description

Despite advances in hypertension prevention and treatment research, its prevalence is high and increasing, while the proportions of hypertensive patients who are aware, treated, and controlled are low, especially in low- and middle-income countries (LMIC). The investigators propose to: assess the needs, barriers, and knowledge gaps of hypertension control programs in the national health care systems of the Central America 4 region LMIC (CA-4: Guatemala, Honduras, El Salvador, and Nicaragua); conduct a cluster randomized trial to test the effect of a multilevel and multicomponent intervention program on blood pressure (BP) control among Guatemalan hypertensive patients; and evaluate the adaptability, feasibility, fidelity, and sustainability of implementing the program in the primary health care systems of the CA-4 region. The investigators will conduct formative research to assess the needs of system-wide intervention programs, barriers and facilitators of BP control strategies, and knowledge gaps about implementation for improving hypertension control in the CA-4 health care systems. The proposed trial will recruit 1,770 study participants from 32 primary care districts (55 patients aged ≥22 years with uncontrolled hypertension/district) within a subnational primary care network managed by the Guatemalan Ministry of Health. Sixteen health districts will be assigned to an 18-month multicomponent intervention, which includes protocol-based treatment using: a standard blood pressure (BP) management algorithm, team-based collaborative care, BP audit and feedback, home BP monitoring, and health coaching on antihypertensive medication adherence and lifestyle modification, and 16 to usual care. BP and other indicators will be measured at baseline and at months 6, 12, and 18. The primary clinical outcome is the difference in the proportion of patients with controlled BP (<140/90 mmHg) between the intervention and control groups at 18 months. The secondary outcome is net change in systolic and diastolic BP from baseline to 18 months. Fidelity of the intervention measured monthly by intensification of treatment by provider-teams (titration or addition of new medications) and adherence to medications in patients will be the primary implementation outcome. Other implementation outcomes will be measured every 6 months. The RE-AIM framework will guide the development, implementation, and assessment of the intervention, which will translate and adapt the Hypertension Control Program in Argentina that has been proven effective and feasible. This project have assembled a multidisciplinary investigative team, which will collaborate with the public primary care network in Guatemala to conduct this implementation research project. The intervention and study outcomes are patient-centered, and patients, MOH provider-teams, and other stakeholders will be engaged at every step of the proposed study. The investigators will disseminate the study findings and promote scale-up of the proven effective intervention program, which will generate urgently needed data on effective, adoptable, and sustainable intervention strategies aimed at reducing BP-related disease burden in CA-4 and other low-income settings.

• Study Type: Interventional
• Enrollment (Actual): 1854
• Phase: Phase 3

Contacts and Locations

Study Locations

• Guatemala
  • Guatemala, Guatemala, 01011
    • Insitute of Nutrition of Central America and Panama

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All patients aged ≥40 years with BP >140/90 mmHg at the time of enrollment
• Patients who receive care at government health facilities

Exclusion Criteria:

• Pregnant women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Patients will receive the usual care.
Experimental: Intervention group; Patients will receive a multicomponent intervention.	Other: Multicomponent intervention; An 18-month multicomponent intervention, which includes protocol-based treatment using: a standard blood pressure (BP) management algorithm, team-based collaborative care, BP audit and feedback, home BP monitoring, and health coaching on antihypertensive medication adherence and lifestyle modification.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of controlled blood pressure	Difference in the proportion of patients with controlled blood pressure (<140/90 mmHg) between the intervention and control groups	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in systolic blood pressure	Net change in systolic blood pressure from baseline to 18 months	18 months
Change in diastolic blood pressure	Net change in diastolic blood pressure from baseline to 18 months	18 months

Collaborators and Investigators

• Sponsor: Institute of Nutrition of Central America and Panama
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); Institute for Clinical Effectiveness and Health Policy; Tulane University School of Public Health and Tropical Medicine; Colorado School of Public Health

Publications and helpful links

General Publications

• Paniagua-Avila A, Fort MP, Glasgow RE, Gulayin P, Hernandez-Galdamez D, Mansilla K, Palacios E, Peralta AL, Roche D, Rubinstein A, He J, Ramirez-Zea M, Irazola V. Evaluating a multicomponent program to improve hypertension control in Guatemala: study protocol for an effectiveness-implementation cluster randomized trial. Trials. 2020 Jun 9;21(1):509. doi: 10.1186/s13063-020-04345-8.

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2019
• Primary Completion (Actual): April 23, 2022
• Study Completion (Actual): April 23, 2022

Study Registration Dates

• First Submitted: April 12, 2018
• First Submitted That Met QC Criteria: April 12, 2018
• First Posted (Actual): April 20, 2018

Study Record Updates

• Last Update Posted (Actual): July 29, 2022
• Last Update Submitted That Met QC Criteria: July 27, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 1U01HL138647-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No