HypertensionNCT03297229
Effect of Peer Mentoring and Blood Pressure Self-monitoring on Hypertension Control.
A study testing Peer mentoring and Self-monitoring in people with Hypertension, run by Institute for Clinical Effectiveness and Health Policy at 10 sites in Argentina.
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Peer mentoring and Self-monitoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 442 participants
- Where
- 10 sitesArgentina
- Study dates
- 4 Apr 2017to 1 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (21 years and older) who only have public health coverage, and have high blood pressure (SBP ≥140 mmHg and / or DBP ≥90 mmHg)
Who cannot join
- Pregnant women, bed-bound, and patients who cannot give informed consent.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Argentina10 sites
Centro de Atención Primaria de la Salud Dr. Balbastro
Corrientes
Centro de Atención Primaria de la Salud N°15 Illia
Corrientes
CAPS 1 Simeon Payba
Paso de los Libres, Corrientes Province
CAPS 10 Plurianual
Paso de los Libres, Corrientes Province
Centro Asistencial Modelo Don Bosco
Quilmes, Buenos Aires
Policlínico Julio Méndez
Quilmes, Buenos Aires
Centro de Salud nº 60 - El Mirador
Salta
Centro de Salud Santa Ana
Salta
UAP Illia
Vicente López, Buenos Aires
UAP Sargento Cabral
Vicente López, Buenos Aires
About this study
Official title: Effectiveness of Peer Mentoring and Blood Pressure Self-monitoring for Blood Pressure Control in Vulnerable Population in Argentina. A Randomized Clinical Trial.
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
- Being tested
- Peer mentoring, Self-monitoring
- Keywords
- Peer mentoring, Self-monitoring, Behavioral economics, Hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer mentoringBehavioural
Peers will be assigned to participants according to common socio-demographic characteristics. Each peer will be assigned up to 5 participants.
Self-monitoringBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Peer mentoring | Experimental | 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. Receives: Behavioral: Peer mentoring |
| Self-monitoring | Experimental | Each participant will receive a blood pressure monitor. The study nurse will teach the participant on how to use the device. Receives: Behavioral: Self-monitoring |
| Control | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Net change in blood pressure levels from baseline to the end of follow-up in in each group.
Measured: 3 months
Secondary outcomes (4)
Controlled hypertension
Proportion of patients with controlled hypertension (Systolic blood pressure <140 mm Hg and diastolic blood pressure <90 mm Hg)
Measured: 3 months
Adherence to antihypertensive medication
Proportion of patients who had adhered to antihypertensive medication according to the Morisky Green Scale.
Measured: 3 months
Intensification of antihypertensive medication
Proportion of patients who increased the number of antihypertensive medications or increase the dose of their antihypertensive medication.
Measured: 3 months
Visits to the clinic
Number of visits to the clinic over the 3 month period of follow-up.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2017
- Study start4 Apr 2017
- Primary completion1 Feb 2018
- Study completion1 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 442 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute for Clinical Effectiveness and Health Policy
- Sponsor type
- University, hospital or other
- Collaborators
- Inter-American Development Bank
- Responsible party
- Sponsor
- Investigators
- Vilma Irazola, MD, PhD, Principal investigator, Institute for Clinical Effectiveness and Health Policy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03297229
- Sponsor's protocol ID
- AR-T1087-P0001
- Status last verified
- Sep 2017
- First submitted
- 26 Sep 2017
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37431737
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Peer Mentoring and Blood Pressure Self-monitoring for Blood Pressure Control in Vulnerable Population in Argentina. A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT03297229
- Acronym / sponsor ID
- AR-T1087-P0001
- Conditions
- Hypertension
- Keywords
- Peer mentoring, Self-monitoring, Behavioral economics, Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 442 participants (actual)
- Lead sponsor
- Institute for Clinical Effectiveness and Health PolicyUniversity, hospital or other
- Collaborators
- Inter-American Development Bank
- Study start
- 4 Apr 2017 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 29 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Peer mentoring | Experimental | Behavioral: Peer mentoringPeers 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. |
| Self-monitoring | Experimental | Behavioral: Self-monitoringEach participant will receive a blood pressure monitor. The study nurse will teach the participant on how to use the device. |
| Control | No intervention | –Usual care |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults (21 years and older) who only have public health coverage, and have high blood pressure (SBP ≥140 mmHg and / or DBP ≥90 mmHg)
Key exclusion criteria (1 listed)
- Pregnant women, bed-bound, and patients who cannot give informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peer mentoringPeers will be assigned to participants according to common socio-demographic characteristics. Each peer will be assigned up to 5 participants. | Behavioural | Peer mentoring |
| Self-monitoringAlong 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. | Behavioural | Self-monitoring |
Primary outcome
Blood pressure
Time frame: 3 months
Net change in blood pressure levels from baseline to the end of follow-up in in each group.
4 secondary outcomes
Controlled hypertension
Time frame: 3 months
Adherence to antihypertensive medication
Time frame: 3 months
Intensification of antihypertensive medication
Time frame: 3 months
Visits to the clinic
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- Derived from this study: PubMed 37431737Nejamis 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vilma Irazola, MD, PhD principal investigator
Institute for Clinical Effectiveness and Health Policy
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer mentoring and Self-monitoring in people with Hypertension, run by Institute for Clinical Effectiveness and Health Policy at 10 sites in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03297229, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2023.