Hypertension Control Program in Argentina (HCPIA)

Hypertension Clinical Trial

Official title:

Comprehensive Approach for Hypertension Prevention and Control in Argentina

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01834131
• Other study ID #: U01HL114197
• Secondary ID: U01HL114197
• Status: Completed
• Phase: N/A
• First received: April 13, 2013
• Last updated: July 12, 2017
• Start date: June 2013
• Est. completion date: October 2016

Study information

• Verified date: July 2017
• Source: Tulane University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1954
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria for Clinics:

• The clinic is affiliated with the Remediar+Redes program.

• The clinic is located in urban poor areas according to the 2010 census data.

• The clinic has =1000 outpatient visits each month, so that sufficient participants can be recruited.

• The minimum distance between the selected clinics will be 10 kilometers to minimize the risk for contamination of the intervention.

• Physician visits and essential medications are free of charge to patients under all circumstances.

• The clinic has a high number of prescriptions for antihypertensive medications.

• The clinic employs community health workers.

• The clinic has general practitioners and nurses.

• The clinic has a history of good performance in the Remediar+Redes program.

• The clinic performs blood draws on patients when appropriate.

Inclusion Criteria for Participants:

• Patients aged =21 years who received primary care from the participating clinics and have hypertension ( SBP =140 mmHg and/or DBP =90 mmHg on at least 2 separate visits) and their spouses (with or without hypertension) and/or any adult hypertensive family members (age =21 years) living in the same household will be included.

• Hypertension patients and their spouses and/or family members must be available for the first baseline nurse home visit.

• The index patient must have a cell phone that receives text messages.

• The family's homes must be located within 10 kilometers from the clinic.

Exclusion Criteria for Participants:

• Hypertension patients who do not have a spouse or another adult with hypertension in the household.

• Plans to move from the neighborhood in the next two years

• Pregnant women or women who are planning to become pregnant in the next two years

• Persons who are bed-bound

• Persons who cannot give informed consent

• Persons with an arm circumference >50 cm

Related Conditions & MeSH terms

• Hypertension

Intervention

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.

Locations

Country	Name	City	State
Argentina	Institute for Clinical Effectiveness and Health Policy	Buenos Aires

Sponsors (3)

Lead Sponsor	Collaborator
Tulane University	Institute for Clinical Effectiveness and Health Policy, National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

Argentina, 

References & Publications (2)

Mills KT, Bundy JD, Kelly TN, Reed JE, Kearney PM, Reynolds K, Chen J, He J. Global Disparities of Hypertension Prevalence and Control: A Systematic Analysis of Population-Based Studies From 90 Countries. Circulation. 2016 Aug 9;134(6):441-50. doi: 10.1161/CIRCULATIONAHA.115.018912. — View Citation

Mills KT, Rubinstein A, Irazola V, Chen J, Beratarrechea A, Poggio R, Dolan J, Augustovski F, Shi L, Krousel-Wood M, Bazzano LA, He J. Comprehensive approach for hypertension control in low-income populations: rationale and study design for the hypertensi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Net change in systolic (SBP) and diastolic BP (DBP) from baseline to month 18 between the intervention and control groups among hypertensive study participants.	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.	Baseline and 18 months
Secondary	Proportion of hypertension control (BP<140/90 mmHg) among hypertensive patients	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.	Baseline and 18 months
Secondary	Self-reported medication adherence among hypertensive patients	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.	Baseline and 18 months
Secondary	Cost-effectiveness of the intervention	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.	Baseline and 18 Months
Secondary	Net change in systolic (SBP) and diastolic BP (DBP) from baseline to month 18 between the intervention and control groups among normotensive study participants	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.	Baseline and 18 months
Secondary	Net change in body weight and waist circumference from baseline to 18 months	Study nurses will take anthropometric measurements on individuals in light clothing without shoes using a standard protocol.	Baseline and 18 months
Secondary	Intensity of treatment	Intensification (titration and/or addition) of antihypertensive medications,compared between the intervention and control groups after 18 months of follow-up.	Baseline and 18 months