Clinical trial NCT03297229: Effect of Peer Mentoring and Blood Pressure Self-monitoring on Hypertension Control.
Official title: Effectiveness of Peer Mentoring and Blood Pressure Self-monitoring for Blood Pressure Control in Vulnerable Population in Argentina. A Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Peer mentoring
Self-monitoring
Behavioral economics
Hypertension
Lead sponsor: Institute for Clinical Effectiveness and Health Policy
Sponsor class: OTHER
Collaborators: name: Inter-American Development Bank
First posted: 2017-09-29
Enrollment: 442
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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.

Primary outcomes:
measure: Blood pressure
timeFrame: 3 months
Secondary outcomes:
measure: Controlled hypertension
timeFrame: 3 months
measure: Adherence to antihypertensive medication
timeFrame: 3 months
measure: Intensification of antihypertensive medication
timeFrame: 3 months
measure: Visits to the clinic
timeFrame: 3 months
Other outcomes:
Locations:
city: Quilmes
country: Argentina
facility: Centro Asistencial Modelo Don Bosco
state: Buenos Aires.
city: Quilmes
country: Argentina
facility: Policlínico Julio Méndez
state: Buenos Aires.
city: Vicente López
country: Argentina
facility: UAP Illia
state: Buenos Aires
city: Vicente López
country: Argentina
facility: UAP Sargento Cabral
state: Buenos Aires
city: Paso de los Libres
country: Argentina
facility: CAPS 1 Simeon Payba
state: Corrientes
city: Paso de los Libres
country: Argentina
facility: CAPS 10 Plurianual
state: Corrientes
city: Corrientes
country: Argentina
facility: Centro de Atención Primaria de la Salud Dr. Balbastro
city: Corrientes
country: Argentina
facility: Centro de Atención Primaria de la Salud N°15 Illia
city: Salta
country: Argentina
facility: Centro de Salud nº 60 - El Mirador
city: Salta
country: Argentina
facility: Centro de Salud Santa Ana
Study officials:
affiliation: Institute for Clinical Effectiveness and Health Policy
name: Vilma Irazola, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: