PARTICIPANT INFORMED CONSENT

 

PROJECT TITLE: MAY MEASUREMENT MONTH 2019 (MMM19)

Principal Investigators: Professor Neil Poulter (Immediate Past-President of International Society of Hypertension)

Lead Co-Investigators: Professor Alta Schutte (President of International Society of Hypertension), Dr Thomas Beaney (Imperial College London, London, UK)

Administrative support: The Conference Collective Limited, 8 Waldegrave Road, Teddington, Middlesex, TW11 8HT, UK. Tel: +44 (0) 2089777997, e-mail: manager@maymeasure.com

You are being invited to take part in a global cross-sectional blood pressure screening survey that forms part of an initiative undertaken by the International Society of Hypertension (ISH) and endorsed by the World Hypertension League (WHL). It is important that clearly understand what this project is about and how you are involved. Your participation is entirely voluntary and you can withdraw at any time.

If you have any questions, please ask your screening team.

This study will be conducted according to the ethical guidelines and principles of the Declaration of Helsinki and other applicable international ethical guidelines. Research ethics committee members or other relevant people may need to inspect the research records.

What is this project all about?

  • High blood pressure is a very common condition worldwide. Because there are no symptoms, many people don’t know they have high blood pressure and this is important as it can lead to heart disease, stroke, kidney disease, and ultimately death.

  • With this screening project we plan to raise awareness of the importance of knowing your blood pressure. We will take measurements to identify those adults with raised blood pressure who require treatment. This data will be used to motivate governments to improve local screening, treatment and facilities.

  • This project will be conducted globally in approximately 100 countries during the month of May 2019. It involves taking blood pressure measurements and entering basic demographic data from adult volunteers. We aim to include over 1 million participants, making this the largest ever global blood pressure screening campaign.

Why have you been invited to participate?

 

  • You have been invited to be part of this project because you are an adult aged 18 years or older. (You must be 18+ to participate.)

  • Ideally you have not had your blood pressure taken during the past 12 months.

 

What will be expected of you?

  • Once you have agreed to take part, we will enter basic information onto a mobile phone or computer application, or onto a paper form. This includes your country, city; when your last blood pressure was last measured; your year and month of birth; your sex; whether you currently take blood pressure medication; whether you have diabetes, smoke, or use alcohol. We may also ask you whether you have ever had a heart attack or stroke. A blood pressure cuff will then be wrapped around your upper arm and you will be expected to remain seated for at least 5 minutes after which your blood pressure (systolic and diastolic) and heart rate will be measured three times. The three readings will also be recorded on the mobile application.

  • The total screening will take approximately 15-20 minutes.

Will you gain anything from taking part in this research?

  • You will know your blood pressure, which is directly related to your risk for heart disease and stroke.

  • We will provide you with dietary and lifestyle information to help keep blood pressure normal. If necessary we will also advise you to consult your healthcare provider for further measurements and treatment.

  • More widely, a central aim of this project is to create awareness at government level to ensure the provision of adequate healthcare facilities, including screening and treatment, to better manage and control high blood pressure.

Are there risks involved in you taking part in this research?

  • There are no physical risks to taking part in this research and having your blood pressure measured.

  • We may find that your blood pressure is high, which may cause you some anxiety, but we will give you advice on making healthy lifestyle choices and refer you for further treatment if necessary.

     

How will we protect your confidentiality and who will see your data?

  • We will not record your name, or any information that identifies you as an individual, anywhere. Your anonymity and privacy will be respected by all involved in this survey, and your results will only be evaluated as part of population studies.

 

What will happen with the findings?

  • We will use the findings to raise awareness in the scientific and medical community, as well as among governments, on the importance of blood pressure measurement, awareness, treatment and control.

 

Will you be paid to take part and are there any costs for you?

This study is funded by the International Society of Hypertension, Servier.

 

You will not be paid to take part in the study and there are no costs to you — whether or not you take part.

Is there anything else that you should know or do?

  • You can go to www.maymeasure.com or contact the International Society of Hypertension if you have any further questions.

Declaration by participant

By ticking the consent box in the app, you agree to take part in the research May Measurement Month 2019 research project.

 

You declare that:

 

  • I have read this information/it was explained to me by a trusted person in a language in which I am fluent and comfortable.

  • I have had a chance to ask questions and they have been answered.

  • I understand that taking part is voluntary and I have not been pressurised to do so.

  • I may choose to leave the study at any time with no negative consequences for me.

  • I may be asked to leave the study before it has finished, if the researcher feels it is in the best interest of the research project.