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

NCT03297229 | Completed

• 1 other identifier: AR-T1087-P0001
• Study Type: interventional
• Target: 442
• Locations: 1 country
• Sites: 10

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.

Conditions

Hypertension

Keywords

Peer mentoring; Self-monitoring; Behavioral economics; Hypertension

Outcome Measures

Primary Outcomes (1)

• Blood pressure

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

  3 months

Secondary Outcomes (4)

• Controlled hypertension

  3 months

• Adherence to antihypertensive medication

  3 months

• Intensification of antihypertensive medication

  3 months

• Visits to the clinic

  3 months

Study Arms (3)

Peer mentoring

EXPERIMENTAL

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

Self-monitoring

EXPERIMENTAL

Each participant will receive a blood pressure monitor. The study nurse will teach the participant on how to use the device.

Behavioral: Self-monitoring

Control

NO INTERVENTION

Usual care

Interventions

Peer mentoring BEHAVIORAL

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

Peer mentoring

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.

Self-monitoring

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (21 years and older) who only have public health coverage, and have high blood pressure (SBP ≥140 mmHg and / or DBP ≥90 mmHg)

You may not qualify if:

• Pregnant women, bed-bound, and patients who cannot give informed consent.

Sponsors & Collaborators

• Institute for Clinical Effectiveness and Health Policy: lead
• Inter-American Development Bank: collaborator

Study Sites (10)

Centro Asistencial Modelo Don Bosco

Quilmes, Buenos Aires, Argentina

Location

Policlínico Julio Méndez

Quilmes, Buenos Aires, Argentina

Location

UAP Illia

Vicente López, Buenos Aires, Argentina

Location

UAP Sargento Cabral

Vicente López, Buenos Aires, Argentina

Location

CAPS 1 Simeon Payba

Paso de los Libres, Corrientes Province, Argentina

Location

CAPS 10 Plurianual

Paso de los Libres, Corrientes Province, Argentina

Location

Centro de Atención Primaria de la Salud Dr. Balbastro

Corrientes, Argentina

Location

Centro de Atención Primaria de la Salud N°15 Illia

Corrientes, Argentina

Location

Centro de Salud nº 60 - El Mirador

Salta, Argentina

Location

Centro de Salud Santa Ana

Salta, Argentina

Location

Related Publications (1)

• Nejamis A, Chaparro M, Gibbons L, Poggio R, Moyano DL, Irazola V. Effectiveness of peer mentoring and self-monitoring to improve blood pressure control in a vulnerable population in Argentina: Pragmatic randomized open-label controlled trial. Chronic Illn. 2024 Dec;20(4):684-698. doi: 10.1177/17423953231187170. Epub 2023 Jul 11.

  PMID: 37431737 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Blood Glucose Self-Monitoring

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Self-Testing; Self Care; Therapeutics; Investigative Techniques

Study Officials

• Vilma Irazola, MD, PhD

  Institute for Clinical Effectiveness and Health Policy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2017
• First Posted: September 29, 2017
• Study Start: April 4, 2017
• Primary Completion: February 1, 2018
• Study Completion: March 1, 2018
• Last Updated: March 7, 2023

Record last verified: 2017-09

Locations

AR (10)