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

NCT ID: NCT03297229

Last Updated: 2023-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 442 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-04
• Study Completion Date: 2018-03-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Peer mentoring

Intervention Type: BEHAVIORAL

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

Self-monitoring

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

Group Type: EXPERIMENTAL

Self-monitoring

Intervention Type: 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.

Control

Usual care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Peer mentoring

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

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Inter-American Development Bank

OTHER

Sponsor Role: collaborator

Institute for Clinical Effectiveness and Health Policy

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vilma Irazola, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Institute for Clinical Effectiveness and Health Policy

Locations

Centro Asistencial Modelo Don Bosco

Quilmes, Buenos Aires, Argentina

Policlínico Julio Méndez

Quilmes, Buenos Aires, Argentina

UAP Illia

Vicente López, Buenos Aires, Argentina

UAP Sargento Cabral

Vicente López, Buenos Aires, Argentina

CAPS 1 Simeon Payba

Paso de los Libres, Corrientes Province, Argentina

CAPS 10 Plurianual

Paso de los Libres, Corrientes Province, Argentina

Centro de Atención Primaria de la Salud Dr. Balbastro

Corrientes, , Argentina

Centro de Atención Primaria de la Salud N°15 Illia

Corrientes, , Argentina

Centro de Salud nº 60 - El Mirador

Salta, , Argentina

Centro de Salud Santa Ana

Salta, , Argentina

Countries

Argentina

References

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.

Reference Type: DERIVED

PMID: 37431737 (View on PubMed)

Other Identifiers

AR-T1087-P0001

Identifier Type: -

Identifier Source: org_study_id