Effect of Peer Mentoring and Blood Pressure Self-monitoring on Hypertension Control.

Study Overview
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Brief Summary
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Cardiovascular diseases are increasing throughout the developing world and are the cause of almost 16.7 million deaths each year, of which 80% occur in low and middle-income countries. As more than three fourth of the global burden of cardiometabolic diseases are related to risk factors connected with lifestyles or behaviors, such as smoking, unhealthy eating, low physical activity, and harmful consumption of alcohol. This burden could be dramatically reduced by changing individual behaviors. This study is focused on interventions that are aimed to improve the adherence to treatment in cardiovascular disease (hypertension), based on a Behavioral Economics approach. Most of public policies targeted to tackle Noncommunicable diseases utilize a rational economic model of behavior. Behavioral economics, by using insights from cognitive psychology and other social sciences, has drawn a lot of attention for its potential to increase healthy behaviors. Interventions informed by Behavioral economics principles seek to rearrange the social or physical environment in such a way to 'nudge' people towards healthier choices and behaviors. This is an individual controlled randomized trial which will be conducted to assess whether the implementation of two strategies, blood pressure self-monitoring plus signing a contract of commitment, and peer mentoring are effective to reduce blood pressure values over a period of 3 months, compared to usual care. This randomized trial will enroll 430 patients from 10 public primary care clinics in Argentina.

Official Title
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Effectiveness of Peer Mentoring and Blood Pressure Self-monitoring for Blood Pressure Control in Vulnerable Population in Argentina. A Randomized Clinical Trial.

Conditions
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Hypertension

Intervention / Treatment
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* Behavioral: Peer mentoring
* Behavioral: Self-monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults (21 years and older) who only have public health coverage, and have high blood pressure (SBP ≥140 mmHg and / or DBP ≥90 mmHg) Exclusion Criteria: Pregnant women, bed-bound, and patients who cannot give informed consent.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Peer mentoring<br>Peers will be patients with hypertension that have already been adequately controlled within the last six months. They will be selected within each center by the staff of the center and invited to participate in the study. | Behavioral: Peer mentoring<br>* Peers will be assigned to participants according to common socio-demographic characteristics. Each peer will be assigned up to 5 participants.<br>|
| Experimental: Self-monitoring<br>Each participant will receive a blood pressure monitor. The study nurse will teach the participant on how to use the device. | Behavioral: Self-monitoring<br>* Along with providing patients with a BP monitor, a commitment contract will be signed, in which participants commit themselves to measure their blood pressure at home at least once a week during the 3 months of the intervention. Each participant will be given a form to weekly recording their blood pressure values.<br>|
| No Intervention: Control<br>Usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | Net change in blood pressure levels from baseline to the end of follow-up in in each group. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Controlled hypertension | Proportion of patients with controlled hypertension (Systolic blood pressure <140 mm Hg and diastolic blood pressure <90 mm Hg) | 3 months | 
| Adherence to antihypertensive medication | Proportion of patients who had adhered to antihypertensive medication according to the Morisky Green Scale. | 3 months | 
| Intensification of antihypertensive medication | Proportion of patients who increased the number of antihypertensive medications or increase the dose of their antihypertensive medication. | 3 months | 
| Visits to the clinic | Number of visits to the clinic over the 3 month period of follow-up. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peer mentoring, Self-monitoring, Behavioral economics, Hypertension