Hypertension Control Program in Argentina (HCPIA)

Not Applicable

Completed

• Conditions: Hypertension

• Registration Number: NCT01834131
• Lead Sponsor: Tulane University

Brief 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.

Study Timeline

• Study First Submitted: 2013-04-13
• Study First Submitted QC: 2013-04-16
• Study First Posted: 2013-04-17
• Study Start: 2013-06
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-12
• Last Update Posted: 2017-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1954

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Net change in systolic (SBP) and diastolic BP (DBP) from baseline to month 18 between the intervention and control groups among hypertensive study participants.	Baseline and 18 months	Three BP measurements will be obtained at each data collection visit by study nurses who are masked to clinic assignment. BP will be measured according to a standard protocol recommended by the American Heart Association. The average of the three measurements will be used to compare the change over 18 months between the intervention and control groups.

Secondary Outcome Measures

Name	Time	Method
Proportion of hypertension control (BP<140/90 mmHg) among hypertensive patients	Baseline and 18 months	The proportion of hypertensives with blood pressure control (defined as (BP\<140/90 mmHg or \< 130/80 mmHg if patient has diabetes of CKD) will be compared between the intervention and control group.
Self-reported medication adherence among hypertensive patients	Baseline and 18 months	The Morisky scale questionnaire will be administered at baseline and 18 months of follow-up to compare medication adherence between the intervention and control groups.
Cost-effectiveness of the intervention	Baseline and 18 Months	All resources involved in conducting this comprehensive intervention program, as well as all patient-level costs, will be documented. Primary incremental cost effectiveness ratio (ICER) measure will be cost per mmHg of change in SBP and DBP.
Net change in systolic (SBP) and diastolic BP (DBP) from baseline to month 18 between the intervention and control groups among normotensive study participants	Baseline and 18 months	Three BP measurements will be obtained at each data collection visit by study nurses who are masked to clinic assignment. BP will be measured according to a standard protocol recommended by the American Heart Association. The average of the three measurements will be used to compare the change over 18 months between the intervention and control groups among normotensives.
Net change in body weight and waist circumference from baseline to 18 months	Baseline and 18 months	Study nurses will take anthropometric measurements on individuals in light clothing without shoes using a standard protocol.
Intensity of treatment	Baseline and 18 months	Intensification (titration and/or addition) of antihypertensive medications,compared between the intervention and control groups after 18 months of follow-up.

Trial Locations

Locations (1)

Institute for Clinical Effectiveness and Health Policy; 🇦🇷 Buenos Aires, Argentina