Comprehensive Approach for Hypertension Prevention and Control in Argentina
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hypertension
- Sponsor
- Tulane University
- Enrollment
- 1954
- Locations
- 1
- Primary Endpoint
- Net change in systolic (SBP) and diastolic BP (DBP) from baseline to month 18 between the intervention and control groups among hypertensive study participants.
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Jiang He, MD, PhD
Professor and Chair, Department of Epidemiology
Tulane University
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Net change in systolic (SBP) and diastolic BP (DBP) from baseline to month 18 between the intervention and control groups among hypertensive study participants.
Time Frame: 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 Outcomes
- Proportion of hypertension control (BP<140/90 mmHg) among hypertensive patients(Baseline and 18 months)
- Self-reported medication adherence among hypertensive patients(Baseline and 18 months)
- Cost-effectiveness of the intervention(Baseline and 18 Months)
- 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)
- Net change in body weight and waist circumference from baseline to 18 months(Baseline and 18 months)
- Intensity of treatment(Baseline and 18 months)