Effect of Peer Mentoring and Blood Pressure Self-monitoring on Hypertension Control.
Primary Purpose
Hypertension
Status
Completed
Phase
Not Applicable
Locations
Argentina
Study Type
Interventional
Intervention
Peer mentoring
Self-monitoring
Sponsored by

About this trial
This is an interventional health services research trial for Hypertension focused on measuring Peer mentoring, Self-monitoring, Behavioral economics, Hypertension
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.
Sites / Locations
- Centro Asistencial Modelo Don Bosco
- Policlínico Julio Méndez
- UAP Illia
- UAP Sargento Cabral
- CAPS 1 Simeon Payba
- CAPS 10 Plurianual
- Centro de Atención Primaria de la Salud Dr. Balbastro
- Centro de Atención Primaria de la Salud N°15 Illia
- Centro de Salud nº 60 - El Mirador
- Centro de Salud Santa Ana
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Peer mentoring
Self-monitoring
Control
Arm Description
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.
Each participant will receive a blood pressure monitor. The study nurse will teach the participant on how to use the device.
Usual care
Outcomes
Primary Outcome Measures
Blood pressure
Net change in blood pressure levels from baseline to the end of follow-up in in each group.
Secondary Outcome Measures
Controlled hypertension
Proportion of patients with controlled hypertension (Systolic blood pressure <140 mm Hg and diastolic blood pressure <90 mm Hg)
Adherence to antihypertensive medication
Proportion of patients who had adhered to antihypertensive medication according to the Morisky Green Scale.
Intensification of antihypertensive medication
Proportion of patients who increased the number of antihypertensive medications or increase the dose of their antihypertensive medication.
Visits to the clinic
Number of visits to the clinic over the 3 month period of follow-up.
Full Information
NCT ID
NCT03297229
First Posted
September 26, 2017
Last Updated
March 6, 2023
Sponsor
Institute for Clinical Effectiveness and Health Policy
Collaborators
Inter-American Development Bank
1. Study Identification
Unique Protocol Identification Number
NCT03297229
Brief Title
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
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
April 4, 2017 (Actual)
Primary Completion Date
February 1, 2018 (Actual)
Study Completion Date
March 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute for Clinical Effectiveness and Health Policy
Collaborators
Inter-American Development Bank
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Peer mentoring, Self-monitoring, Behavioral economics, Hypertension
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
442 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Peer mentoring
Arm Type
Experimental
Arm Description
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.
Arm Title
Self-monitoring
Arm Type
Experimental
Arm Description
Each participant will receive a blood pressure monitor. The study nurse will teach the participant on how to use the device.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual care
Intervention Type
Behavioral
Intervention Name(s)
Peer mentoring
Intervention Description
Peers will be assigned to participants according to common socio-demographic characteristics. Each peer will be assigned up to 5 participants.
Intervention Type
Behavioral
Intervention Name(s)
Self-monitoring
Intervention Description
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.
Primary Outcome Measure Information:
Title
Blood pressure
Description
Net change in blood pressure levels from baseline to the end of follow-up in in each group.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Controlled hypertension
Description
Proportion of patients with controlled hypertension (Systolic blood pressure <140 mm Hg and diastolic blood pressure <90 mm Hg)
Time Frame
3 months
Title
Adherence to antihypertensive medication
Description
Proportion of patients who had adhered to antihypertensive medication according to the Morisky Green Scale.
Time Frame
3 months
Title
Intensification of antihypertensive medication
Description
Proportion of patients who increased the number of antihypertensive medications or increase the dose of their antihypertensive medication.
Time Frame
3 months
Title
Visits to the clinic
Description
Number of visits to the clinic over the 3 month period of follow-up.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vilma Irazola, MD, PhD
Organizational Affiliation
Institute for Clinical Effectiveness and Health Policy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro Asistencial Modelo Don Bosco
City
Quilmes
State/Province
Buenos Aires.
Country
Argentina
Facility Name
Policlínico Julio Méndez
City
Quilmes
State/Province
Buenos Aires.
Country
Argentina
Facility Name
UAP Illia
City
Vicente López
State/Province
Buenos Aires
Country
Argentina
Facility Name
UAP Sargento Cabral
City
Vicente López
State/Province
Buenos Aires
Country
Argentina
Facility Name
CAPS 1 Simeon Payba
City
Paso de los Libres
State/Province
Corrientes
Country
Argentina
Facility Name
CAPS 10 Plurianual
City
Paso de los Libres
State/Province
Corrientes
Country
Argentina
Facility Name
Centro de Atención Primaria de la Salud Dr. Balbastro
City
Corrientes
Country
Argentina
Facility Name
Centro de Atención Primaria de la Salud N°15 Illia
City
Corrientes
Country
Argentina
Facility Name
Centro de Salud nº 60 - El Mirador
City
Salta
Country
Argentina
Facility Name
Centro de Salud Santa Ana
City
Salta
Country
Argentina
12. IPD Sharing Statement
Learn more about this trial
Effect of Peer Mentoring and Blood Pressure Self-monitoring on Hypertension Control.
We'll reach out to this number within 24 hrs