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

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Behavioral: Peer mentoring; Behavioral: Self-monitoring

• Registration Number: NCT03297229
• Lead Sponsor: Institute for Clinical Effectiveness and Health Policy

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-04
• Status Verified: 2017-09
• Study First Submitted: 2017-09-26
• Study First Submitted QC: 2017-09-26
• Study First Posted: 2017-09-29
• Primary Completion: 2018-02-01
• Study Completion: 2018-03-01
• Last Update Submitted: 2023-03-06
• Last Update Posted: 2023-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 442

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Peer mentoring	Peer mentoring	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.
Self-monitoring	Self-monitoring	Each participant will receive a blood pressure monitor. The study nurse will teach the participant on how to use the device.

Primary Outcome Measures

Name	Time	Method
Blood pressure	3 months	Net change in blood pressure levels from baseline to the end of follow-up in in each group.

Secondary Outcome Measures

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

Trial Locations

Locations (10)

UAP Sargento Cabral; 🇦🇷 Vicente López, Buenos Aires, Argentina

Centro de Atención Primaria de la Salud N°15 Illia; 🇦🇷 Corrientes, Argentina

Policlínico Julio Méndez; 🇦🇷 Quilmes, Buenos Aires., Argentina

CAPS 1 Simeon Payba; 🇦🇷 Paso de los Libres, Corrientes, Argentina

UAP Illia; 🇦🇷 Vicente López, Buenos Aires, Argentina

Centro de Salud nº 60 - El Mirador; 🇦🇷 Salta, Argentina

Centro de Salud Santa Ana; 🇦🇷 Salta, Argentina

Centro de Atención Primaria de la Salud Dr. Balbastro; 🇦🇷 Corrientes, Argentina

Centro Asistencial Modelo Don Bosco; 🇦🇷 Quilmes, Buenos Aires., Argentina

CAPS 10 Plurianual; 🇦🇷 Paso de los Libres, Corrientes, Argentina