Hypertension Control Program in Argentina (HCPIA)

NCT01834131 | Completed

• 1 other identifier: U01HL114197
• Study Type: interventional
• Target: 1,954
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

hypertension; community health worker; home health education; medication adherence; mobile health; physician education; home blood pressure monitoring; implementation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

Study Arms (2)

Usual Care

NO INTERVENTION

Clinics assigned to usual care will not receive any of the intervention components. Physicians in these clinics will continue to treat patients using their usual methods. Participants from these clinics will not receive community health worker visits or the mobile health intervention

Comprehensive Intervention

EXPERIMENTAL

1. Physicians will receive training in the use of treatment algorithms based on hypertension guidelines. 2. Community health workers (CHW) will be trained in facilitating behavioral change through BP monitoring, medication management, and lifestyle modifications. CHW will serve as a source of education, motivation, and social support, and as facilitators of healthcare utilization for participants. CHW will conduct home visits, schedule appointments with primary care physicians, deliver antihypertensive medications to patients' homes, and provide tailored counseling to address barriers to behavior change. 3. Individualized text messages to promote lifestyle changes and reminders to reinforce medication adherence will be sent to participants weekly.

Behavioral: Comprehensive Intervention

Interventions

Comprehensive Intervention BEHAVIORAL

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

Comprehensive Intervention

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tulane University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Institute for Clinical Effectiveness and Health Policy: collaborator

Study Sites (1)

Institute for Clinical Effectiveness and Health Policy

Buenos Aires, C1414CPV, Argentina

Location

Related Publications (5)

• 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.

  PMID: 27502908 BACKGROUND

• 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.

  PMID: 24978148 RESULT

• 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.

  PMID: 33769555 DERIVED

• 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.

  PMID: 31473065 DERIVED

• 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.

  PMID: 28975305 DERIVED

MeSH Terms

Conditions

Hypertension; Medication Adherence

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Jiang He, MD, PhD

  Tulane University Health Sciences Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair, Department of Epidemiology

Study Record Dates

• First Submitted: April 13, 2013
• First Posted: April 17, 2013
• Study Start: June 1, 2013
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: July 17, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Immediately after main paper published.

Locations

AR (1)