Sponsors and corporate partners: International Society of Hypertension, Centres for Disease Control

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1 CLINICAL STUDY PROTOCOL OUTLINE Prtcl Date: February 8 th, 2018 Versin: Internatinal 2.0 Prject title: MAY MEASUREMENT MONTH 2018 (MMM18) Lead rganisatin: Internatinal Sciety f Hypertensin (ISH) Spnsrs and crprate partners: Internatinal Sciety f Hypertensin, Centres fr Disease Cntrl and Preventin (CDC), Omrn, Servier Principal Investigatr: Prfessr Neil Pulter, President f Internatinal Sciety f Hypertensin Neil Pulter, MBBS MSc FRCP FMed Sci Prfessr f Preventive Cardivascular Medicine, Internatinal Centre fr Circulatry Health and Imperial Clinical Trials Unit, Imperial Cllege Lndn Stadium Huse, 68 Wd Lane Lndn W12 7RH Lead C-Investigatrs: Prfessr Alta Schutte (Vice-President f Internatinal Sciety f Hypertensin), Prfessr Maciej Tmaszewski (Secretary f Internatinal Sciety f Hypertensin) Administrative supprt fr the prject and the cntact details: The Cnference Cllective Limited, 8 Waldegrave Rad, Teddingtn, Middlesex, TW11 8HT, UK Tel: +44 (0) , manager@maymeasure.cm Executive summary: In 2017, ISH cnducted a glbal bld pressure screening survey acrss apprximately 100 cuntries, cllecting data frm ver 1.2 millin participants. Fllwing the success f the 2017 campaign, in 2018, ISH prpses t cnduct a secnd glbal crss-sectinal bld pressure (BP) survey f vlunteer 1

2 adults (aged 18 years) wh ideally have nt had their BPs measured fr at least a year befre BP screening. The survey will be cnducted in apprximately 100 cuntries each incrprating a variable number f screening sites. Basic demgraphic and clinical infrmatin as well as BP measurements will be cllected by health prfessin vlunteers thrughut May Sitting bld pressure will be measured in triplicate accrding t standardised specified methds. The data will be annymised, cded and transferred electrnically (thrugh a purpse-designed applicatin r using an Excel spreadsheet) t a central AWS DynamDB database. Screenees whse BP readings are cnsistent with the current definitin f hypertensin will be prvided with written dietary and lifestyle advice. They will als be prvided with a referral t receive medicatins and/r fllw up supprt, accrding t lcal facilities. 2

3 1. Ratinale Raised BP is the biggest single cntributing risk factr t glbal death (1) and t the glbal burden f disease (1). This impact is largely mediated thrugh increased rates f cardivascular disease, specifically crnary artery disease and strke, and renal disease. Because cardivascular (CV) disease affects apprximately ne third f adults glbally, it represents the largest epidemic ever experienced by mankind. Raised BP currently causes apprximately 9.4 millin deaths each year wrldwide (1) and this figure is expected t rise, given an expanding and aging glbal ppulatin. The aetilgy f raised BP is largely explicable by identified envirnmental factrs such as verweight, excessive intake f alchl and dietary salt, and insufficient exercise (2). Several drug classes have been shwn t prvide cst-effective BP lwering fr the preventin f the adverse CV sequelae f raised BP. Despite the availability f these antihypertensive medicatins, glbal data suggest that less than half f thse classified as hypertensive are aware f their prblem (3). Furthermre, less than a third f thse wh are treated fr hypertensin get their BPs cntrlled t currently recmmended targets (3). Even assuming treatment and cntrl rates are maximised amng thse currently diagnsed as being hypertensive (3) it is clear that a huge beneficial impact n mrbidity and mrtality, and massive reductin in this burden f disease attributed t raised BP, can be achieved by increasing awareness thrugh enhanced screening fr raised BP. 2. Aims 2.1 T highlight the imprtance f measuring bld pressure. 2.2 T identify and reduce the BPs f thse peple wh require interventin t lwer their BP accrding t current guidelines. 3. Objectives 3.1 T screen at least 1 millin peple aged 18 years wh ideally have nt had their BPs 3

4 measured fr at least a year prir t the current BP screening. 3.2 T supply diet and lifestyle treatment advice t all thse screened wh have BPs in the hypertensive range. 3.3 T prvide advice n hw best t receive BP-lwering medicatins (if required) and further fllw-up f raised BP accrding t lcal facilities. 3.4 T use the data n untreated and inadequately treated hypertensin t mtivate gvernments t imprve lcal screening facilities and plicies, and thereby reduce the glbal burden f disease assciated with raised BP. 4. Methdlgy 4.1 Inclusin criteria: i. age 18 years ii. cnsent fr participatin given accrding t lcal requirements. 4.2 Prcedures i. Prviding infrmatin abut the study and cllecting cnsent fr participatin. All written materials t be used by screenees will use vcabulary in a language that is clearly understd at the study sites. These materials will be prvided in several cre languages (English, French, Spanish, Prtuguese, Hindi, Chinese) and will be available t dwnlad frm the maymeasure.cm website. ii. Cllectin f site infrmatin and basic demgraphic infrmatin: a) All infrmatin shuld be cllected prir t BP measurements b) Where the app is used, data that will remain the same thrughut the screening sessin will nly need t be entered nce (e.g. date, lcatin). c) The fllwing data shuld be cllected n all screenees (cre-dataset) Cuntry 4

5 City/Twn/Village Date f measurement Time f measurement Age Sex At least 1 SBP, DBP and heart rate In additin, the fllwing variables will be recrded when available/pssible: Site ID and/r address f screening site Type f lcatin f screening site hspital/clinic, pharmacy, wrkplace, ther public area (indrs), ther public area (utdrs), ther Temperature at screening site Have yu ever had their bld pressure measured? yes/n If s, was it within the last 12 mnths? yes/n Did yu participate in May Measurement Mnth 2017? yes/n Have yu been diagnsed with high bld pressure by a health prfessinal (except in pregnancy)? yes/n Are yu currently taking prescribed bld pressure/antihypertensive treatment? yes/n/dn t knw Are yu pregnant? yes/n Self-declared ethnicity Black / White / Suth Asian / East Asian / Suth-East Asian / Arabic / Hispanic (US nly), Mixed, Other Are yu currently fasting? yes/n D yu have diabetes? yes/n/dn t knw D yu use tbacc? yes/n D yu cnsume alchl? never r rarely/1-3 times per mnth/at least nce per week Have yu had a heart attack in the past? yes/n/dn t knw 5

6 Have yu had a strke in the past? yes/n/dn t knw Measured r self-declared weight (estimate if required) Measured r self-declared height (estimate if required) What type f BP machine was used t take the readings? autmated/nt autmated What is the manufacturer name and mdel type? Which arm was used t take the bld pressure reading? left/right SBP (2-3) DBP (2-3) Heart rate (2-3) iii. BP measurements a) BP shuld preferably be measured by an autmated electrnic device, but can als be measured by a cnventinal sphygmmanmeter using a stethscpe. b) If a sphygmmanmeter is used, the first and fifth Krtkff sunds (the appearance and disappearance f sunds) will be recrded as the systlic and diastlic BP. c) BP shuld be measured n the upper-arm d) Measure the circumference f the arm (at the mid arm level) and ensure that the crrect size f arm cuff is used Fr arms with circumference < 32 cm, use regular cuff Fr arms with circumference cm, use large cuff Fr arms with circumference >42 cm, use extra-large cuff Fr arms with circumference <20cm use paediatric cuff e) The cuff shuld be placed at the heart level f) The patient s arm being used fr the measurement shuld rest cmfrtably n a table g) BP shuld be measured n ne arm nly, preferably left, and the arm used shuld be recrded 6

7 h) Prir t measurement: The participant shuld be seated with their backs supprted and with their legs resting n the grund and in the uncrssed psitin fr 5 min Participants shuld nt have smked immediately befre r during the measurement i) Three (3) BP readings shuld be taken and recrded using ne f the methds described in sectin iii) k) with 1 min between readings. j) Fr each BP reading, the autmated BP devices als prvide data n heart rate, and this infrmatin shuld als be captured using ne f the methds described in sectin iii) k). k) Data cllected n each participant shuld be recrded and submitted int the database via the MMM app (prduced by Clarifi Media). If it is nt pssible t use the app at the screening site, data shuld be cllected n paper using the MMM data capture frm prvided by the MMM Prject Team. The paper frms shuld then be laded nt the app either by manually inputting the data r, if using a mbile device, via the inbuilt camera and the app s scan and capture functinality. If neither f the abve ptins abve are available at the screening site then it will be pssible t submit data n an excel spreadsheet, the template fr which will be prvided by the MMM prject team. l) If the auscultatry methd/sphygmmanmeter is used, the heart rate shuld be established during the 1 minute after each BP reading, and als recrded n the mbile app. m) Definitin f hypertensin: being n at least ne antihypertensive medicatin taken fr raised BP r the average SBP (mean f the last 2 f 3 readings) 140 mmhg and/r the average DBP (mean f the last 2 f 3 readings) 90 mmhg n) The type and mdel f BP machine used t measure BPs will be recrded. 7

8 iv. Dietary and lifestyle infrmatin prvided t hypertensive patients t include a) reduce salt cnsumptin b) dn t drink t much alchl stick t lcal recmmendatins c) dn t smke d) reduce caffeine intake e) reduce fat and sugar intake f) engage in regular physical exercise fr at least 30 minutes n mst f the days f the week g) eat plenty f fruit and vegetables daily (including beetrt and beetrt juice where pssible) h) maintain a healthy bdy weight i) avid stress where pssible and allw time fr relaxatin A generic package f advice will be prvided centrally fr lcal adaptatin and can be translated lcally if required. 5. Data Management 5.1 Surce Data: Data will be annymised and cllected directly frm screenees and entered nt the bespke MMM App befre and immediately after BP measurements. The MMM App will need t dwnladed and registered in an area with internet cnnectin, but can then be used where internet facilities are nt available. Where a laptp r mbile device is nt available, data can be cllected, handwritten n t a template frm, prvided by the MMM prject team, and then transferred int the database using a pht-capture functinality n the MMM app which uses Optical Character Recgnitin. The app will be available in 8 languages: English, Arabic, Chinese (Cantnese/Mandarin), French, Hindi, Prtuguese, Plish and Spanish. If use f the MMM app is nt at all pssible, then an Excel spreadsheet will be prvided by the MMM prject team and data can be submitted n that. 5.2 Database: Upladed bld pressure recrds will be held in an AWS DynamDB database in the UK. On a peridic basis, the database is exprted t an AWS S3 drp-flder. Access t this drp-flder and t DynamDB will be prvided t the nminated MMM data analyst. 8

9 5.3 Access t Data: The Study Principal Investigatr representing ISH will be custdians f the data n behalf f all cllabrating natinal investigatrs. Natinal, reginal and glbal data will be available fr research purpses n applicatin t the Principal Investigatr. 6. Statistical Analysis 6.1 Sample size: The ttal f >1 millin adults (18+years) was selected n the basis f including a large enugh sample f BP data in each participating cuntry, sufficient t raise awareness at a natinal level Data Analysis: Analyses will include but nt be restricted t: i) The prevalence f previusly undiagnsed hypertensin at a natinal, reginal, glbal and ethnic level. ii) Age and sex stratified levels f systlic (S) BP, diastlic (D) BP, BP variability and prevalence f knwn and newly diagnsed hypertensin generated at a natinal, reginal and glbal level. iii) The prevalence f uncntrlled hypertensin amng thse n treatment fr hypertensin. iv) The assciatin between the same BP parameters and rm temperature, altitude, ethnic grup, week day and time f day will be evaluated at an ethnic, reginal and glbal level. v) The assciatin between the same BP parameters and previus CV disease, pulse rate, diabetes, smking and alchl intake and, where available, anthrpmetric variables. 7. Ethical Issues 7.1 In accrdance with lcal requirements, infrmed cnsent will be acquired and recrded frm all screenees having received a simple verbal explanatin f what data are t be cllected and why. 7.2 Regulatry Authrity apprval: In thse cuntries r regins where ethics apprval is required fr an annymised screening prject such authrisatin will be btained frm the relevant Regulatry Authrity befre BP screening begins. 7.3 Subject Cnfidentiality: 9

10 All data cllected n the MMM App will be annymised and nt traceable t the individual screenees. 8 Study Management Overall management structure: The selected fficers f ISH will act as the Executive Cmmittee prviding glbal versight fr the prject, cllectin, prcessing, analysis and interpretatin f the data. The recruitment will be initiated, mnitred and supervised by the natinal leaders (at least 1 per cuntry). They will be respnsible fr identifying recruitment sites, each with a centre lead (experienced clinician/nurse/pharmacist). The natinal leaders will reprt directly t ne f the ISH Reginal Advisry Grups (RAGs) which cver: Africa Eurpe (including Cyprus) Americas Suth and West Asia and The Middle East Nrth Asia, Suth-East Asia and Oceania 9. References 1. Lim et al: Lancet 2012:380: Pulter et al: Lancet 2015:386: Chw et al: JAMA 2013: 310:959:68 10