NCT01834131

Hypertension Control Program in Argentina (HCPIA)

Comprehensive Approach for Hypertension Prevention and Control in Argentina

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,954 (actual)
• Sponsor: Tulane University · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

Summary

The objective of this cluster randomized trial is to test whether a comprehensive intervention program within a national public primary care system will improve hypertension control among uninsured hypertensive patients and their families in Argentina.

Detailed description

Background: Although the efficacy and effectiveness of lifestyle modifications and antihypertensive pharmaceutical treatment for the prevention and control of hypertension and concomitant cardiovascular disease and premature death have been demonstrated in randomized controlled trials, this scientific knowledge has not been fully applied in the general population, especially in low and middle income countries. Objectives: To test whether a comprehensive intervention program within a national public primary care system will improve hypertension control among uninsured hypertensive patients and their families in Argentina Design: Cluster randomized trial Study Participants: 1,890 study participants from 18 primary care clinics within a public primary care network in Argentina will be recruited. Patients with hypertension from the participating clinics, their spouses, and their adult hypertensive family members will be enrolled. Intervention: Nine clinics with approximately 945 participants will be randomly assigned to the comprehensive intervention group and 9 clinics with similar participants to the usual care group. The comprehensive intervention, including health care provider education, a home-based intervention among patients and their families (lifestyle modification and home blood pressure \[BP\] monitoring) delivered by community health workers, and a mobile health intervention, will last for 18 months. Outcomes: BP and other indicators will be measured at baseline and months 6, 12, and 18 during follow-up using standard methods. The primary outcome is a net change in systolic (SBP) and diastolic BP (DBP) from baseline to month 18 between the intervention and control groups among hypertensive study participants. The secondary outcomes are the proportion of hypertensive patients with adequate BP control (BP\<140/90 mmHg), cost-effectiveness of hypertension control, and net BP changes in normotensive participants.

Conditions

• Hypertension

Interventions

Type	Name	Description
BEHAVIORAL	Comprehensive Intervention	The comprehensive intervention includes physician education, a community health worker home intervention and a mobile health intervention. Please see Arm Description for details.

Timeline

• Start date: 2013-06-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2013-04-17
• Last updated: 2017-07-17

Locations

1 site across 1 country: Argentina