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

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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Behavioral: Peer mentoring; Behavioral: Self-monitoring

• Study Type: Interventional
• Enrollment (Actual): 442
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Argentina
  • Corrientes, Argentina
    • Centro de Atención Primaria de la Salud Dr. Balbastro
  • Corrientes, Argentina
    • Centro de Atención Primaria de la Salud N°15 Illia
  • Salta, Argentina
    • Centro de Salud nº 60 - El Mirador
  • Salta, Argentina
    • Centro de Salud Santa Ana
  • Buenos Aires
    • Vicente López, Buenos Aires, Argentina
      • UAP Illia
    • Vicente López, Buenos Aires, Argentina
      • UAP Sargento Cabral
  • Buenos Aires.
    • Quilmes, Buenos Aires., Argentina
      • Centro Asistencial Modelo Don Bosco
    • Quilmes, Buenos Aires., Argentina
      • Policlínico Julio Méndez
  • Corrientes
    • Paso de los Libres, Corrientes, Argentina
      • CAPS 1 Simeon Payba
    • Paso de los Libres, Corrientes, Argentina
      • CAPS 10 Plurianual

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Usual care
Experimental: 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.	Behavioral: Peer mentoring; Peers will be assigned to participants according to common socio-demographic characteristics. Each peer will be assigned up to 5 participants.
Experimental: Self-monitoring; Each participant will receive a blood pressure monitor. The study nurse will teach the participant on how to use the device.	Behavioral: Self-monitoring; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Institute for Clinical Effectiveness and Health Policy
• Collaborators: Inter-American Development Bank
• Investigators: Principal Investigator: Vilma Irazola, MD, PhD, Institute for Clinical Effectiveness and Health Policy

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2017
• Primary Completion (Actual): February 1, 2018
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: September 26, 2017
• First Submitted That Met QC Criteria: September 26, 2017
• First Posted (Actual): September 29, 2017

Study Record Updates

• Last Update Posted (Estimate): March 7, 2023
• Last Update Submitted That Met QC Criteria: March 6, 2023
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Hypertension; Peer mentoring; Self-monitoring; Behavioral economics
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: AR-T1087-P0001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No