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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03297229
• Other study ID #: AR-T1087-P0001
• Status: Completed
• Phase: N/A
• Start date: April 4, 2017
• Est. completion date: March 1, 2018

Study information

• Verified date: September 2017
• Source: Institute for Clinical Effectiveness and Health Policy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 442
• Est. completion date: March 1, 2018
• Est. primary completion date: February 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension

Intervention

Behavioral:
• Peer mentoring
Peers will be assigned to participants according to common socio-demographic characteristics. Each peer will be assigned up to 5 participants.
• 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.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Institute for Clinical Effectiveness and Health Policy	Inter-American Development Bank

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure	Net change in blood pressure levels from baseline to the end of follow-up in in each group.	3 months
Secondary	Controlled hypertension	Proportion of patients with controlled hypertension (Systolic blood pressure <140 mm Hg and diastolic blood pressure <90 mm Hg)	3 months
Secondary	Adherence to antihypertensive medication	Proportion of patients who had adhered to antihypertensive medication according to the Morisky Green Scale.	3 months
Secondary	Intensification of antihypertensive medication	Proportion of patients who increased the number of antihypertensive medications or increase the dose of their antihypertensive medication.	3 months
Secondary	Visits to the clinic	Number of visits to the clinic over the 3 month period of follow-up.	3 months