ISRCTN ISRCTN75832474
DOI https://doi.org/10.1186/ISRCTN75832474
Secondary identifying numbers International 2.1
Submission date
28/01/2019
Registration date
13/02/2019
Last edited
20/09/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Study website

Contact information

Prof Neil Poulter
Scientific

Imperial College School of Medicine
London
W12
United Kingdom

Prof Francesco Cappuccio
Scientific

University of Warwick
Warwick Medical School
Coventry
CV4 7AL
Zimbabwe

ORCiD logoORCID ID 0000-0002-7842-5493
Ms Lisa Woodward
Public

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

Study information

Study designCross-sectional survey in a convenience population sample
Primary study designObservational
Secondary study designEpidemiological study
Study setting(s)Community
Study typeScreening
Scientific titleUK contribution to May Measurement Month, a global strategy to measure blood pressure in 25M people across the world
Study acronymMMM18
Study objectivesTo 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(s)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
Health condition(s) or problem(s) studiedHigh blood pressure (hypertension)
InterventionThe 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 typeBehavioural
Primary outcome measureSystolic 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 measuresMeasure 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 study start date01/09/2017
Completion date30/04/2019

Eligibility

Participant type(s)All
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants1 million
Key inclusion criteria1. Age ≥ 18 years
2. Consent for participation given according to local requirements
Key exclusion criteriaUnable to provide informed consent
Date of first enrolment01/05/2018
Date of final enrolment31/05/2018

Locations

Countries of recruitment

  • England
  • Ireland
  • United Kingdom

Study participating centre

Imperial College School of Medicine
Clinical Trial Unit
White City Campus
London
W12 0BZ
United Kingdom

Sponsor information

International Society of Hypertension
Charity

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

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

Funders

Funder type

Charity

International Society of Hypertension
Private sector organisation / International organizations
Alternative name(s)
ISH
Location
United Kingdom
Centers for Disease Control and Prevention
Government organisation / National government
Alternative name(s)
United States Centers for Disease Control and Prevention, Centros para el Control y la Prevención de Enfermedades, Centers for Disease Control, U.S. Centers for Disease Control and Prevention, CDC, U.S. CDC
Location
United States of America
Servier
Private sector organisation / For-profit companies (industry)
Alternative name(s)
Servier Laboratories, Laboratoires Servier
Location
France

Results and Publications

Intention to publish date31/12/2019
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryStored in repository
Publication and dissemination plan1. 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 planThe 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/.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article Global results 01/07/2019 20/09/2021 Yes No
HRA research summary 28/06/2023 No No

Editorial Notes

20/09/2021: Publication reference added.
16/04/2019: Internal review.