Clinical trial NCT03504124: Multicomponent Intervention to Improve Hypertension Control in Central America
Official title: Implementing a Multicomponent Intervention to Improve Hypertension Control in Central America
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Arterial Hypertension
Lead sponsor: Institute of Nutrition of Central America and Panama
Sponsor class: OTHER
Collaborators: name: Tulane University School of Public Health and Tropical Medicine
name: Institute for Clinical Effectiveness and Health Policy
name: Colorado School of Public Health
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2018-04-20
Enrollment: 1854
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A cluster randomized trial including 32 rural health districts managed by the Ministry of Health (MOH) of Guatemala. Sixteen health districts will be assigned to a multicomponent intervention and 16 to usual care. Each health district will recruit 55 patients aged ≥40 years with uncontrolled hypertension.
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of controlled blood pressure
timeFrame: 18 months
Secondary outcomes:
measure: Change in systolic blood pressure
timeFrame: 18 months
measure: Change in diastolic blood pressure
timeFrame: 18 months
Other outcomes:
Locations:
city: Guatemala
country: Guatemala
facility: Insitute of Nutrition of Central America and Panama
Study officials:
References:
citation: 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.