Multicomponent Intervention to Improve Hypertension Control in Central America
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|ClinicalTrials.gov Identifier: NCT03504124|
Recruitment Status : Recruiting
First Posted : April 20, 2018
Last Update Posted : October 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Arterial Hypertension||Other: Multicomponent intervention||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1770 participants|
|Intervention Model:||Parallel Assignment|
|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.|
|Masking:||None (Open Label)|
|Official Title:||Implementing a Multicomponent Intervention to Improve Hypertension Control in Central America|
|Actual Study Start Date :||July 17, 2019|
|Estimated Primary Completion Date :||May 2022|
|Estimated Study Completion Date :||May 2022|
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.
No Intervention: Control group
Patients will receive the usual care.
- Proportion of controlled blood pressure [ Time Frame: 18 months ]Difference in the proportion of patients with controlled blood pressure (<140/90 mmHg) between the intervention and control groups
- Change in systolic blood pressure [ Time Frame: 18 months ]Net change in systolic blood pressure from baseline to 18 months
- Change in diastolic blood pressure [ Time Frame: 18 months ]Net change in diastolic blood pressure from baseline to 18 months
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03504124
|Contact: Manuel Ramirez-Zea, MD, PhD||+502 firstname.lastname@example.org|
|Contact: Diego Hernandez, MD, MPH||+502 email@example.com|
|Insitute of Nutrition of Central America and Panama||Recruiting|
|Guatemala, Guatemala, 01011|
|Contact: Manuel A Ramirez-Zea, MD PhD firstname.lastname@example.org|