Hypertension Control Program in Argentina (HCPIA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Tulane University Health Sciences Center
Sponsor:
Collaborators:
Institute for Clinical Effectiveness and Health Policy
Information provided by (Responsible Party):
Jiang He, MD, PhD, Tulane University Health Sciences Center
ClinicalTrials.gov Identifier:
NCT01834131
First received: April 13, 2013
Last updated: November 25, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Hypertension
Behavioral: Comprehensive Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comprehensive Approach for Hypertension Prevention and Control in Argentina

Resource links provided by NLM:


Further study details as provided by Tulane University Health Sciences Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • Proportion of hypertension control (BP<140/90 mmHg or < 130/80 mmHg if patient has diabetes of CKD) among hypertensive patients [ Time Frame: Baseline and 18 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 18 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 18 Months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 18 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 18 months ] [ Designated as safety issue: No ]
    Study nurses will take anthropometric measurements on individuals in light clothing without shoes using a standard protocol.

  • Increase in number of primary care visits resulting in intensity of treatment [ Time Frame: Baseline and 18 months ] [ Designated as safety issue: No ]
    Number of primary care visits for each participant will be recorded and compared between the intervention and control groups after 18 months of follow-up.


Estimated Enrollment: 1888
Study Start Date: June 2013
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Usual Care
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
Experimental: Comprehensive Intervention
  1. Physicians will receive training in the use of treatment algorithms based on hypertension guidelines, including both pharmacologic and non-pharmacologic components.
  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
The comprehensive intervention includes physician education, a community health worker home intervention and a mobile health intervention. Please see Arm Description for details.

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: 1,888 study participants from 16 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: Eight clinics with approximately 944 participants will be randomly assigned to the comprehensive intervention group and 8 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 or <130/80 mmHg if patient has diabetes or CKD), net BP changes in normotensive participants, and cost-effectiveness.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01834131

Contacts
Contact: Adolfo Rubinstein, MD, MSc, PhD (+54-11) 4777-8767 arubinstein@iecs.org.ar

Locations
Argentina
Institute for Clinical Effectiveness and Health Policy Recruiting
Buenos Aires, Argentina, C1414CPV
Contact: Adolfo Rubinstein, MD    (+54-11) 4777-8767    arubinstein@iecs.org.ar   
Principal Investigator: Adolfo Rubinstein, MD         
Sponsors and Collaborators
Tulane University Health Sciences Center
Institute for Clinical Effectiveness and Health Policy
Investigators
Principal Investigator: Jiang He, MD, PhD Tulane University Health Sciences Center
  More Information

No publications provided

Responsible Party: Jiang He, MD, PhD, Professor and Chair, Department of Epidemiology, Tulane University Health Sciences Center
ClinicalTrials.gov Identifier: NCT01834131     History of Changes
Other Study ID Numbers: U01HL114197, U01HL114197
Study First Received: April 13, 2013
Last Updated: November 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Tulane University Health Sciences Center:
hypertension
community health worker
home health education
medication adherence
mobile health
physician education
home blood pressure monitoring
implementation

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014