Overview

This trial has been completed.

Condition hypertension
Treatment comprehensive intervention
Sponsor Tulane University
Collaborator National Heart, Lung, and Blood Institute (NHLBI)
Start date June 2013
End date October 2016
Trial size 1950 participants
Trial identifier NCT01834131, U01HL114197

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(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
(Experimental)
Physicians will receive training in the use of treatment algorithms based on hypertension guidelines. 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. Individualized text messages to promote lifestyle changes and reminders to reinforce medication adherence will be sent to participants weekly.
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.

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.
time frame: Baseline and 18 months

Secondary Outcomes

Measure
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
Self-reported medication adherence among hypertensive patients
time frame: Baseline and 18 months
Cost-effectiveness of the intervention
time frame: 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
time frame: Baseline and 18 months
Net change in body weight and waist circumference from baseline to 18 months
time frame: Baseline and 18 months
Increase in number of primary care visits resulting in intensity of treatment
time frame: Baseline and 18 months

Eligibility Criteria

Male or female participants at least 21 years old.

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

Additional Information

Official title Comprehensive Approach for Hypertension Prevention and Control in Argentina
Principal investigator Jiang He, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Tulane University.