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OpenTrials
Completed

NCT Number: NCT03297229

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

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro Asistencial Modelo Don Bosco, Quilmes, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Peer Mentoring

Behavioral

Peers will be assigned to participants according to common socio-demographic characteristics. Each peer will be assigned up to 5 participants.

Self-monitoring

Behavioral

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.

Primary outcomes

  1. Blood pressure

    Time frame: 3 months

    Net change in blood pressure levels from baseline to the end of follow-up in in each group.

Secondary outcomes

  1. Controlled hypertension

    Time frame: 3 months

    Proportion of patients with controlled hypertension (Systolic blood pressure <140 mm Hg and diastolic blood pressure <90 mm Hg)

  2. Adherence to antihypertensive medication

    Time frame: 3 months

    Proportion of patients who had adhered to antihypertensive medication according to the Morisky Green Scale.

  3. Intensification of antihypertensive medication

    Time frame: 3 months

    Proportion of patients who increased the number of antihypertensive medications or increase the dose of their antihypertensive medication.

  4. Visits to the clinic

    Time frame: 3 months

    Number of visits to the clinic over the 3 month period of follow-up.

Sponsors and collaborators

Lead sponsor

Institute for Clinical Effectiveness and Health Policy

Other

Collaborators

  • Inter-American Development Bank

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 29, 2017
Registry last updated
Mar 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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