Condition category
Circulatory System
Date applied
28/01/2019
Date assigned
13/02/2019
Last edited
11/02/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
In 2017, the International Society of Hypertension (ISH) conducted a global blood pressure screening survey across about 100 countries, collecting data from over 1.2 million participants. Following the success of the 2017 campaign, in 2018, ISH proposes to conduct a second global blood pressure (BP) survey of volunteer adults (aged 18 and over) who ideally have not had their BPs measured for at least a year before BP screening.

Who can participate?
Volunteers aged 18 and over

What does the study involve?
Basic demographic and clinical information as well as BP measurements are collected by health profession volunteers throughout May 2018. Sitting blood pressure is measured three times according to standardised specified methods. Participants whose BP readings are consistent with the current definition of hypertension are provided with written dietary and lifestyle advice. They are also provided with a referral to receive medications and/or follow up support, according to local facilities.

What are the possible benefits and risks of participating?
Participants will benefit from individual and immediate feedback on their blood pressure status and, where blood pressure is above targets, they are given lifestyle advice and a card with their blood pressure readings and the suggestion to confirm the readings with their GPs at the earliest possible opportunity. There are no serious risks to the participants. Blood pressure cuff inflation may cause minor discomfort. People asked to see their GP at some point might develop concerns or anxiety about this – the MMM team will provide written explanations of the lack of risk involved in being asked to see the GP due to a potentially raised blood pressure.

Where is the study run from?
Imperial College School of Medicine (UK)

When is the study starting and how long is it expected to run for?
September 2017 to April 2019

Who is funding the study?
1. International Society of Hypertension (UK)
2. Centers for Disease Control and Prevention (USA)
3. Servier (France)

Who is the main contact?
1. Prof. Neil Poulter
2. Prof. Francesco Cappuccio
3. Lisa Woodward

Trial website

http://maymeasure.com/

Contact information

Type

Scientific

Primary contact

Prof Neil Poulter

ORCID ID

Contact details

Imperial College School of Medicine
London
W12
United Kingdom

Type

Scientific

Additional contact

Prof Francesco Cappuccio

ORCID ID

http://orcid.org/0000-0002-7842-5493

Contact details

University of Warwick
Warwick Medical School
Coventry
CV4 7AL
Zimbabwe

Type

Public

Additional contact

Ms Lisa Woodward

ORCID ID

Contact details

ISH c/o Imperial College School of Medicine
London
W12
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

International 2.1

Study information

Scientific title

UK contribution to May Measurement Month, a global strategy to measure blood pressure in 25M people across the world

Acronym

MMM18

Study hypothesis

To screen at least 1 million people aged ≥ 18 years who ideally have not had their BPs measured for at least a year prior to the current BP screening.

Ethics approval

NHS Health Research Authority, North East – York Research Ethics Committee, NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne NE2 4NQ, Local contact: Ms Kerry Dunbar, REC Manager, Tel: +44 (0)207 104 8082, Email: nrescommittee.northeast-york@nhs.net, 08/02/2018, REC ref: 17/NE/0087, IRAS project ID: 225418

Study design

Cross-sectional survey in a convenience population sample

Primary study design

Observational

Secondary study design

Epidemiological study

Trial setting

Community

Trial type

Screening

Patient information sheet

Condition

High blood pressure (hypertension)

Intervention

The survey will be conducted in approximately 100 countries each incorporating a variable number of screening sites. Basic demographic and clinical information as well as BP measurements will be collected by health profession volunteers throughout May 2018. Sitting blood pressure will be measured in triplicate according to standardised specified methods. The data will be anonymised, coded and transferred electronically (through a purpose-designed application or using an Excel spreadsheet) to a central AWS DynamoDB database. Screenees whose BP readings are consistent with the current definition of hypertension will be provided with written dietary and lifestyle advice. Participants will also be provided with a referral to receive medications and/or follow up support, according to local facilities.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Systolic and diastolic blood pressures and pulse rate measured up to three times in the sitting position after 5 min rest using automated blood pressure monitors or, if unavailable, ordinary sphygmomanometer. Measurements taken once at baseline.

Secondary outcome measures

Measure of body mass index (in kg/m2) taken as weight in kg or lb (converted in kg) and height in cm or ft and inch (and converted in cm). Measures will be either self-reported or measured with a stadiometer and electronic weighing scales. Measurements taken once at baseline.

Overall trial start date

01/09/2017

Overall trial end date

30/04/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Age ≥ 18 years
2. Consent for participation given according to local requirements

Participant type

All

Age group

Adult

Gender

Both

Target number of participants

1 million

Participant exclusion criteria

Unable to provide informed consent

Recruitment start date

01/05/2018

Recruitment end date

31/05/2018

Locations

Countries of recruitment

Ireland, United Kingdom

Trial participating centre

Imperial College School of Medicine
Clinical Trial Unit White City Campus
London
W12
United Kingdom

Sponsor information

Organisation

International Society of Hypertension

Sponsor details

ISH Secretariat
c/o The Conference Collective Ltd.
8 Waldegrave Road
Teddington
TW11 8HT
United Kingdom

Sponsor type

Charity

Website

http://ish-world.com/contact.htm

Funders

Funder type

Charity

Funder name

International Society of Hypertension

Alternative name(s)

ISH

Funding Body Type

private sector organisation

Funding Body Subtype

international

Location

United Kingdom

Funder name

Centers for Disease Control and Prevention

Alternative name(s)

CDC

Funding Body Type

government organisation

Funding Body Subtype

federal/national government

Location

United States of America

Funder name

Servier

Alternative name(s)

Laboratoires Servier, Servier Laboratories

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

France

Results and Publications

Publication and dissemination plan

1. To present at national and international meetings
2. To publish in international journals
3. To hold public engagement meetings
4. To use dissemination by media

IPD sharing statement
The data will be stored at Imperial College CTU in anonymised form. The MMM team (under the overall responsibility of Prof. Neil Poulter and Senior Statistician Thomas Beaney) will handle analyses centrally. Written informed consent was provided by each participant. For further information visit http://maymeasure.com/.

Intention to publish date

31/12/2019

Participant level data

Stored in repository

Basic results (scientific)

Publication list









































































































































































































































































































































































































































































































































































































































































































































































































































































































































Thomas Beaney, MRCP












Aletta E Schutte, PhD












Maciej Tomaszewski, MD












Cono Ariti, MSc












Louise M Burrell, MD












Rafael R Castillo, FPCP












Fadi J Charchar, PhD












Albertino Damasceno, PhD












Ruan Kruger, PhD












Daniel T Lackland, DrPH












Peter M Nilsson, MD












Dorairaj Prabhakaran, DM












Agustin J Ramirez, MD












Markus P Schlaich, MD












Jiguang Wang, PhD












Michael A Weber, MD












Neil R Poulter, FMed Sci 
















on behalf of the
MMM Investigators























































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































Thomas Beaney, MRCP












Aletta E Schutte, PhD












Maciej Tomaszewski, MD












Cono Ariti, MSc












Louise M Burrell, MD












Rafael R Castillo, FPCP












Fadi J Charchar, PhD












Albertino Damasceno, PhD












Ruan Kruger, PhD












Daniel T Lackland, DrPH












Peter M Nilsson, MD












Dorairaj Prabhakaran, DM












Agustin J Ramirez, MD












Markus P Schlaich, MD












Jiguang Wang, PhD












Michael A Weber, MD












Neil R Poulter, FMed Sci 
















on behalf of the
MMM Investigators

















































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































Poulter NR, Lackland DT. May Measurement Month: a global blood pressure screening campaign. Lancet. 2017; 389: 1678-1680
Beaney T, Schutte AE, Poulter NR •
Lackland DT

May Measurement Month: a global blood pressure screening campaign.
Lancet. 2017; 389: 1678-1680


































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