Clinical trial NCT01834131: Hypertension Control Program in Argentina (HCPIA)
Official title: Comprehensive Approach for Hypertension Prevention and Control in Argentina
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: hypertension
community health worker
home health education
medication adherence
mobile health
physician education
home blood pressure monitoring
implementation
Lead sponsor: Tulane University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: Institute for Clinical Effectiveness and Health Policy
First posted: 2013-04-17
Enrollment: 1954
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Net change in systolic (SBP) and diastolic BP (DBP) from baseline to month 18 between the intervention and control groups among hypertensive study participants.
timeFrame: Baseline and 18 months
Secondary outcomes:
measure: Proportion of hypertension control (BP<140/90 mmHg) among hypertensive patients
timeFrame: Baseline and 18 months
measure: Self-reported medication adherence among hypertensive patients
timeFrame: Baseline and 18 months
measure: Cost-effectiveness of the intervention
timeFrame: Baseline and 18 Months
measure: Net change in systolic (SBP) and diastolic BP (DBP) from baseline to month 18 between the intervention and control groups among normotensive study participants
timeFrame: Baseline and 18 months
measure: Net change in body weight and waist circumference from baseline to 18 months
timeFrame: Baseline and 18 months
measure: Intensity of treatment
timeFrame: Baseline and 18 months
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Institute for Clinical Effectiveness and Health Policy
Study officials:
affiliation: Tulane University Health Sciences Center
name: Jiang He, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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 hypertension control program in Argentina. Am J Med Sci. 2014 Aug;348(2):139-45. doi: 10.1097/MAJ.0000000000000298.
citation: Palmer MJ, Machiyama K, Woodd S, Gubijev A, Barnard S, Russell S, Perel P, Free C. Mobile phone-based interventions for improving adherence to medication prescribed for the primary prevention of cardiovascular disease in adults. Cochrane Database Syst Rev. 2021 Mar 26;3(3):CD012675. doi: 10.1002/14651858.CD012675.pub3.
citation: Poggio R, Melendi SE, Beratarrechea A, Gibbons L, Mills KT, Chen CS, Nejamis A, Gulayin P, Santero M, Chen J, Rubinstein A, He J, Irazola V. Cluster Randomized Trial for Hypertension Control: Effect on Lifestyles and Body Weight. Am J Prev Med. 2019 Oct;57(4):438-446. doi: 10.1016/j.amepre.2019.05.011. Epub 2019 Aug 29.
citation: He J, Irazola V, Mills KT, Poggio R, Beratarrechea A, Dolan J, Chen CS, Gibbons L, Krousel-Wood M, Bazzano LA, Nejamis A, Gulayin P, Santero M, Augustovski F, Chen J, Rubinstein A; HCPIA Investigators. Effect of a Community Health Worker-Led Multicomponent Intervention on Blood Pressure Control in Low-Income Patients in Argentina: A Randomized Clinical Trial. JAMA. 2017 Sep 19;318(11):1016-1025. doi: 10.1001/jama.2017.11358.