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

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ClinicalTrials.gov Identifier: NCT03297229
Recruitment Status : Recruiting
First Posted : September 29, 2017
Last Update Posted : September 29, 2017
Sponsor:
Collaborator:
Inter-American Development Bank
Information provided by (Responsible Party):
Institute for Clinical Effectiveness and Health Policy

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.


Condition or disease Intervention/treatment Phase
Hypertension Behavioral: Peer mentoring Behavioral: Self-monitoring Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 430 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Effectiveness of Peer Mentoring and Blood Pressure Self-monitoring for Blood Pressure Control in Vulnerable Population in Argentina. A Randomized Clinical Trial.
Actual Study Start Date : April 4, 2017
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : March 2018

Arm Intervention/treatment
Experimental: 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.
Behavioral: Peer mentoring
Peers will be assigned to participants according to common socio-demographic characteristics. Each peer will be assigned up to 5 participants.

Experimental: Self-monitoring
Each participant will receive a blood pressure monitor. The study nurse will teach the participant on how to use the device.
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.

No Intervention: Control
Usual care



Primary Outcome Measures :
  1. Blood pressure [ Time Frame: 3 months ]
    Net change in blood pressure levels from baseline to the end of follow-up in in each group.


Secondary Outcome Measures :
  1. Controlled hypertension [ Time Frame: 3 months ]
    Proportion of patients with controlled hypertension (Systolic blood pressure <140 mm Hg and diastolic blood pressure <90 mm Hg)

  2. Adherence to antihypertensive medication [ Time Frame: 3 months ]
    Proportion of patients who had adhered to antihypertensive medication according to the Morisky Green Scale.

  3. Intensification of antihypertensive medication [ Time Frame: 3 months ]
    Proportion of patients who increased the number of antihypertensive medications or increase the dose of their antihypertensive medication.

  4. Visits to the clinic [ Time Frame: 3 months ]
    Number of visits to the clinic over the 3 month period of follow-up.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03297229


Contacts
Contact: Vilma Irazola, MD, PhD +541147778767 virazola@iecs.org.ar

Locations
Argentina
Centro Asistencial Modelo Don Bosco Active, not recruiting
Quilmes, Buenos Aires., Argentina
Policlínico Julio Méndez Active, not recruiting
Quilmes, Buenos Aires., Argentina
UAP Illia Active, not recruiting
Vicente López, Buenos Aires, Argentina
UAP Sargento Cabral Active, not recruiting
Vicente López, Buenos Aires, Argentina
CAPS 1 Simeon Payba Recruiting
Paso de los Libres, Corrientes, Argentina
CAPS 10 Plurianual Recruiting
Paso de los Libres, Corrientes, Argentina
Centro de Atención Primaria de la Salud Dr. Balbastro Recruiting
Corrientes, Argentina
Centro de Atención Primaria de la Salud N°15 Illia Recruiting
Corrientes, Argentina
Centro de Salud nº 60 - El Mirador Active, not recruiting
Salta, Argentina
Centro de Salud Santa Ana Active, not recruiting
Salta, Argentina
Sponsors and Collaborators
Institute for Clinical Effectiveness and Health Policy
Inter-American Development Bank
Investigators
Principal Investigator: Vilma Irazola, MD, PhD Institute for Clinical Effectiveness and Health Policy

Responsible Party: Institute for Clinical Effectiveness and Health Policy
ClinicalTrials.gov Identifier: NCT03297229     History of Changes
Other Study ID Numbers: AR-T1087-P0001
First Posted: September 29, 2017    Key Record Dates
Last Update Posted: September 29, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Institute for Clinical Effectiveness and Health Policy:
Peer mentoring
Self-monitoring
Behavioral economics
Hypertension

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases