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HypertensionNCT01834131

Hypertension Control Program in Argentina (HCPIA)

A study testing Comprehensive Intervention in people with Hypertension, run by Tulane University at 1 site in Argentina.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 21 years and olderHealthy volunteers can take part
Conditions the study is for
Hypertension
What is being tested?
Comprehensive Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,954 participants
Where
1 siteArgentina
Study dates
Jun 2013to Oct 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 14Show fewer
  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Argentina1 site

  • Institute for Clinical Effectiveness and Health Policy

    Buenos Aires, C1414CPV

Other trials in Argentina

About this study

Official title: Comprehensive Approach for Hypertension Prevention and Control in Argentina

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.

Read the 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.

Conditions
Hypertension
Being tested
Comprehensive Intervention
Keywords
hypertension, community health worker, home health education, medication adherence, mobile health, physician education, home blood pressure monitoring, implementation
Medical subject headings
Hypertension, Medication Adherence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Comprehensive InterventionBehavioural

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

Study groups in NCT01834131
Study groupRoleWhat they receive
Usual CareNo interventionClinics 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 InterventionExperimental1. 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.
Receives: Behavioral: Comprehensive Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline and 18 months

Secondary outcomes (6)

  1. 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.

    Measured: Baseline and 18 months

  2. 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.

    Measured: Baseline and 18 months

  3. 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.

    Measured: Baseline and 18 Months

  4. 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.

    Measured: Baseline and 18 months

  5. 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.

    Measured: Baseline and 18 months

  6. Intensity of treatment

    Intensification (titration and/or addition) of antihypertensive medications,compared between the intervention and control groups after 18 months of follow-up.

    Measured: Baseline and 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Apr 2013 (estimated)
  2. Study startJun 2013
  3. Primary completionOct 2016
  4. Study completionOct 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,954 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01834131
Sponsor's protocol ID
U01HL114197
Other IDs
U01HL114197
Status last verified
Jul 2017
First submitted
13 Apr 2013
Last updated
17 Jul 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: Our study data sharing plan will comply with all NIH policies for data sharing. Sharing of data and scientific findings with the research and clinical communities will be executed through the centralized NIH data repository, publications in peer reviewed journals, and presentations at scientific meetings. Data sharing will be implemented in a timely manner. The study data, including data from baseline and follow-up visits, will be prepared for transmission to the NHLBI data repository beginning two years after the last subject completes the study visit. These data will be free of identifiers that allow identification of individual research participants either directly or through "deductive disclosure." In addition, we will offer through our public access website opportunities for outside investigators to collaborate with us using the complete study data and samples.

Publications

  • 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.

    PubMed 27502908

  • 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.

    PubMed 24978148

  • 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.

    PubMed 33769555

  • 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.

    PubMed 31473065

  • 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.

    PubMed 28975305

Questions about this trial

What is this clinical trial studying?

A study testing Comprehensive Intervention in people with Hypertension, run by Tulane University at 1 site in Argentina.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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. (time frame: Baseline and 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01834131, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2017.

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