Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03504124
Other study ID # 1U01HL138647-01
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date July 17, 2019
Est. completion date April 23, 2022

Study information

Verified date July 2022
Source Institute of Nutrition of Central America and Panama
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1854
Est. completion date April 23, 2022
Est. primary completion date April 23, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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 Design


Related Conditions & MeSH terms


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.

Locations

Country Name City State
Guatemala Insitute of Nutrition of Central America and Panama Guatemala

Sponsors (5)

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

Country where clinical trial is conducted

Guatemala, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Change in systolic blood pressure Net change in systolic blood pressure from baseline to 18 months 18 months
Secondary Change in diastolic blood pressure Net change in diastolic blood pressure from baseline to 18 months 18 months
See also
  Status Clinical Trial Phase
Recruiting NCT05684055 - "Community-based, eHealth Supported Management of Cardiovascular Risk Factors by Lay Village Health Workers (ComBaCaL aHT TwiC 1 & ComBaCaL aHT TwiC 2) N/A
Active, not recruiting NCT05436730 - "Escape" Phenomenon of the Antihypertensive Therapy Efficacy
Not yet recruiting NCT03294070 - Fimasartan Plus Amlodipine on Hemodynamic Parameters and Arterial Stiffness in Patients With Hypertension Phase 4
Recruiting NCT01959997 - Comparison of Redo PVI With vs. Without Renal Denervation for Recurrent AF After Initial PVI Phase 2
Completed NCT00983632 - Selective Vagus Nerve Stimulation in Human N/A
Recruiting NCT06098300 - Effects of Change in Blood Pressure on Retinal Capillary Rarefaction in Patients With Arterial Hypertension
Completed NCT04564118 - A Retrospective Analysis of the Adherence to Clinical Practice Guidelines Using the "MedicBK" Digital Platform in Patients With Hypertension and Atrial Fibrillation
Terminated NCT04677322 - TO ASSESS THE EFFECTIVENESS OF THE INTERVENTION OF THE LOW-SODIUM DIET IN PATIENTS WITH HTA
Completed NCT04278001 - Clinical Usefullness of the Cuffless SOMNOtouch NIBP Device for 24-hour Ambulatory Blood Pressure Measurement N/A
Withdrawn NCT03047538 - Fixed Combination for Lipid and Blood Pressure Control Phase 4
Completed NCT03046264 - Invasive Validation of Non-invasive Central Blood Pressure Measurements Using Oscillometric Pulse Wave Analysis N/A
Completed NCT02620995 - Effects of Sildenafil on Penile Vascular Function in Hypertensive Men With Erectile Dysfunction Phase 4
Completed NCT02041832 - Detection of Subclinical Atrial Fibrillation in High Risk Patients Using Implantable Loop Recorder N/A
Completed NCT01459120 - Comparison of Door-to-door Versus Community Gathering to Provide HIV Counseling and Testing Services in Rural Lesotho N/A
Completed NCT01546181 - Retinal Imaging by Adaptive Optics in Healthy Eyes and During Retinal and General Diseases
Recruiting NCT01132001 - Ambulatory Versus Home Blood Pressure Measurement N/A
Completed NCT01454583 - Registry for Ambulant Therapy With RAS-Inhibitors in Hypertension-patients in Germany N/A
Recruiting NCT03917758 - Antidiuretic Function Before and During Treatment With SGLT2 Inhibitors N/A
Completed NCT03722524 - The Use of TrIple Fixed-dose Combination in the Treatment of Arterial Hypertension
Completed NCT03539627 - Azilsartan Medoxomil in Hypertensive pAtients With Stable Ischemic Heart Disease and DiabEtes MEllitus.