3. summit-d pil v1.0 25-jun-2020...2020/06/25 · summit-d participant information leaflet version...

SuMMiT-D Participant Information Leaflet Version 1.0, 25-June-2020IRAS project number 280928 REC reference number 20/WS/0103Chief Investigator: Professor Andrew Farmer Page 1 of 11

We would like to invite you to take part in a type 2 diabetes study

called SuMMiT-D.

The SuMMiT-D team have developed a new text messaging system that provides hints and

tips about managing diabetes. We would like to test the system compared to usual diabetes

care, by asking some people to use the system alongside their usual care.

Our aim is to help you, and other people with type 2 diabetes, improve your quality of

life.

This system may help you to improve your knowledge and understanding about type

2 diabetes and taking medicines to treat it.

The system may also help GPs and other healthcare professionals provide better

support for people with diabetes in the future.

Before you decide if you would like to take part, it is important that you understand why we

are doing this research and what your involvement would be. Please take time to read the

following information carefully and decide if you wish to take part. You may like to talk to

others, friends or family members about this study. If there is anything that is not clear or if

you would like more information, please ask us.

Study team contact details can be found at the end of this document.

SuMMiT-D: Support through mobile messaging & digital health technology for diabetes

PARTICIPANT INFORMATION


What is the purpose of this study?

Facts about diabetes

Type 2 diabetes is a lifelong condition that causes a person’s blood

sugar (glucose) to become too high.

It can cause serious long-term health problems. In the UK, it affects

more than 4 million.

Medicines to lower blood glucose, blood pressure, and cholesterol, can

stop the complications of diabetes developing, if taken as intended.

However, people often face difficulties in taking medicines regularly and

have concerns about starting new medicines.

Text messages for health support

Previous research has shown that brief mobile text messages have

been effective in helping improve health for some conditions. They can

be sent to large numbers of people and could be a useful way of

providing additional support for people with type 2 diabetes.

Receiving brief messages may contribute to improved health, but more

research is needed to ensure they work better and are relevant to

different groups of people.

The SuMMiT-D health management support tool

Over several years, we have worked together with healthcare

professionals and drawn on patients’ experiences to develop an

automated messaging system. Our work shows that text messages can

be used to provide support, hints and tips about living with type 2

diabetes.

We now need to test this system in a wide group of people with type 2

diabetes. We want to understand how helpful the system would be if it

were made available to patients by their GP.


Aim of the study The aim of the SuMMiT-D Study is to compare how effective sending

health-related text messages to support people with type 2 diabetes is,

compared with usual care. We plan to recruit just under 1000

participants to this study.

Why have I been

invited?

We are inviting people from participating GP practices if they are

over 35, have type 2 diabetes, have access to a mobile phone and are

being prescribed tablets to lower their blood sugar, blood pressure or

cholesterol levels.

You cannot take part if you are pregnant or have been pregnant within

the last three months. You cannot participate if another person in the

household is already taking part in this study. We aim to involve 958

people in total.

Taking part in the study does not require any face to face visits

with either your practice or the study team


What will happen if I decide to take part?

Expressing your interest

If you have not already sent us a text to express your interest and

would like to take part, then text REGISTER and your full name

to XXXXXXXXXXXX .

First steps and eligibility

A member of the study team will contact you to answer any

questions you may have. You can then make an informed

decision about taking part in the study.

We will ask you a few questions to confirm you are eligible to

take part.

After we have confirmed you are eligible and you are happy to

continue, we will ask you for some further information, including

preferred contact number, postal address and email address. If

you do not want to take part, we will delete all of your personal

information.

If you are not eligible to take part, we may ask to keep some

basic contact information (such as name, preferred phone

number and email address) so we can contact you if you become

eligible during the study recruitment period.

Consent If you choose to take part in the study, you will be asked to sign a

consent form, either online or on paper. This is to confirm that

you have understood what taking part in the study involves and

that you consent to us using relevant information from your

medical notes. If you complete your consent form online, you

can download and print the completed form. If you need help, we

can talk you through how to sign your consent form.

Initial questionnaires

Once you have completed your eligibility and consent forms you

will be asked to fill in questionnaires, which will take

approximately 20 minutes. You can choose to do this either

online or on paper. In order to complete your questionnaires, you

will need to know your NHS number, which can be found on your

invitation letter or on other letters from your GP.

Register John Smith


Randomisation Once we have received your completed questionnaires you will

be randomly allocated to one of two groups. You will have an

equal chance of being allocated to either group. Neither you nor

any of the research team can choose the group you will be in.

During the study (52 weeks)

The intervention group will continue with usual care and will

also receive messages from the SuMMiT-D system. Three to four

health-related text messages will be sent to you each week.

The control group will continue with usual care only. You will

receive a text message approximately once every four weeks to

let you know you are still part of the study. However, this will not

be related to your health.

If you are in the intervention group, you will be able to indicate

your preferences for the sort of messages you might receive. To

ask for more or fewer messages of different types, you can text

LIKE or DISLIKE after any message.

Whichever group you are in you can pause or stop the messages

at any time. If you choose to stop receiving messages, a member

of the trial team will contact you to note your decisions on

stopping. You will be sent a guide to help you to interact with the

system.

Your participation in the study will be for one year (52 weeks).

Participants in both groups will be contacted at approximately 13,

26, and 52 weeks to complete further questionnaires. The 13-

and 26-week questionnaires will take approximately 10 minutes

to complete, the 52-week questionnaire will take approximately

20 minutes to complete.

You will be invited to complete these either online or by post and

return them to us.

Subsequent contacts and reminders

If we have not received your questionnaires within a week, a

study team member will contact you.


Interviews We are aiming to interview up to 60 participants, and you may be

asked if you would like to take part in these interviews.

If you choose to take part, a member of the study team will

arrange to speak with you. Some people may be asked to be

interviewed twice, initially after receiving messages for

approximately 4 weeks and then again at the end of your

participation in the study. Alternatively you may be asked to be

interviewed only once at the end of the study. If you take part in

the initial interviews you may be asked questions about your

experience with taking your diabetes medication and with

managing your condition. If you take part in the final interviews,

you will be asked a few questions about using the system, your

opinion of the messages, and if the system has influenced how

you are taking your medication and self-managing your diabetes.

Each interview will be conducted over the phone, last no more

than one hour and will be arranged at a time that suits you.

Audio recordings of these interviews will be transcribed verbatim

and the de-identified transcripts will be stored securely on

University servers. Audio recordings will be deleted at the end of

the study and de-identified transcripts will be kept for up to 20

years after completion of the study.


Do I have to takepart?

No. It is entirely up to you if you wish to take part. You should

take part only if you want to and you can change your mind at any

time.

What will happen if I don’t want to carry on with the study?

You can withdraw at any time without giving a reason. This will

not affect the standard of care you receive. You can withdraw

from the study, but information collected up to that point may still

be used by the researchers. If you wish to withdraw from the

study, please contact the study team via email or phone using the

contact details at the end of this document.

How have patients been involved in developing this study?

This study builds on earlier work in which we invited people with

type 2 diabetes to share their views with us about their

experiences of managing their condition and how a digital health

system could support them. Approximately 400 people with type 2

diabetes and a Patient and Public Involvement panel have

contributed to the development of this project. Some of this work

was carried out in the South Asian community.

Are there any disadvantages or risks from taking part?

This is a simple automated text messaging system and so we do

not expect you will experience any problems from taking part in

this research. Usual caution with the use of mobile phones is

needed, for example, not texting or reading text messages while

driving or walking. Completing the questionnaires will take up

some of your time.

What are the possible benefits of taking part?

You may improve your knowledge and understanding about type

2 diabetes and taking medicines to treat it but we cannot

guarantee that you will directly benefit from taking part in this

study. You will be helping research by contributing towards the

further development of the SuMMiT-D system.

Will my GP know I’m taking part?

Yes, your GP practice is involved in the study, and will have sent

you the invitation for the study Also, with your permission, we will

write to your GP to let them know you are taking part.


Will I be reimbursed for taking part?

You will not be reimbursed or paid for taking part in this research.

Will my taking part in the study be kept confidential?

Personal identifiable data (e.g. name, date of birth, NHS number)

will be collected so we can contact you to help with your

enrolment in the study and registration on the SuMMiT-D system.

This data will be stored in a secure encrypted database separate

from your clinical data collected for research purposes. Your

clinical information will be coded with a participant identification

number so you will not be able to be identified by anyone other

than the study team. Access to both databases is restricted to

study team members only. Responsible members of the

University of Oxford and the relevant NHS Trust(s) may be given

access to data for monitoring or audit of the study to ensure that

the research is complying with applicable regulations.

What will happen to my data?

Data protection regulation requires that we state the legal basis

for processing information about you. In the case of research this

is a ’task in the public interest’. The University of Oxford is the

data controller and is responsible for looking after your information

and using it properly.

We will be using information from you and your medical records

(provided by your practice) in order to undertake this study, and

will use the minimum personally-identifiable information possible.

We will keep identifiable information about you for six to twelve

months after the study has finished. This excludes any research

documents with personal information such as consent forms,

which will be held securely at the University of Oxford for twenty

years after the end of the study.

Your GP practice will also keep a copy of your consent form in

keeping with local policy for retention of medical notes.

Audio recordings may be transcribed by professional transcribers

who have a confidentiality agreement with the University of

Oxford. They will be sent encrypted audio files, identified only by

an ID number, via a secure file sharing system, completed typed

transcripts are returned in the same way. The transcriber will not

retain the recording after it has been typed out and returned to the

research team. This processing of data will be formalised in a


What happens at the end of the study?

written agreement to ensure it is undertaken confidentially and

securely. Recordings and transcripts will be used for research

purposes only.

The University of Oxford has a contract with text message

network provider Essendex. They will use your mobile phone

number and name to send you the messages, the messages you

receive will contain your name. They will not use this information

for any other purpose than this study. They will keep identifiable

information about you from this study for up to two years following

your last message received.

We will share identifiable data (including your name, gender, date

of birth, and NHS number) in a secure manner (including

encryption during data transfer) with NHS Digital for all the people

that give us consent to access their data.

NHS Digital will use this information to identify the relevant

records in their databases and provide the research team with

details of any hospital admissions for consenting participants in

the study. This information will be securely stored and analysed by

the team at Bangor University. It will only have your participant ID

and no personal details. If you wish to know more about NHS

Digital, please visit their website https://digital.nhs.uk/

Data protection regulation provides you with control over your

personal data and how it is used. When you agree to your

information being used in research, however, some of those rights

may be limited in order for the research to be reliable and

accurate. Further information about your rights with respect to

your personal data is available at

https://compliance.web.ox.ac.uk/individual-rights

You can find out more about how we use your information by

contacting xxx@xxxxxxxxx

The results of this study will be presented in academic and

professional journals, and conferences to inform other

professionals of the work we have been doing. Some of the data

may also be used for educational purposes, such as teaching

research students. Neither your individual data nor you would be

identified in any report or publication.


What if there is a

problem? Given the nature of this study, it is highly unlikely that you would

suffer harm by taking part. However, the University of Oxford, as

Sponsor, has appropriate insurance in place in the unlikely event

that you suffer any harm as a direct consequence of your

participation in this study.

If you wish to complain about any aspect of the way in which you

have been approached or treated or how your information is

handled during the course of this study, you should contact

Professor Andrew Farmer by phone: 01865 617942 or email:

[email protected] or you may contact the

University of Oxford Clinical Trials and Research Governance

(CTRG) office on 01865 616480, or the head of CTRG, email:

[email protected].

Who is organising and funding the study?

The sponsor of this study is the University of Oxford. This

research study is organised by the Nuffield Department of Primary

Care Health Sciences and the Institute of Biomedical Engineering

at the University of Oxford working with the University of

Manchester and Bangor University. The Oxford University

Hospitals NHS Foundation Trust and Oxford Health NHS

Foundation Trust are also taking part.

The research is funded by the National Institute for Health

Research (NIHR) Programme Grants for Applied Research

(project reference RP-PG-1214-20003).

Who has reviewed the SuMMiT-D study?

All research in the NHS is looked at by an independent group of

people, called a Research Ethics Committee, to protect

participants’ interests. This study has been reviewed and given

favourable opinion by the West of Scotland REC 5 Research

Ethics Committee.


Thank you for taking the time to read this leaflet

If you would like any further information about the study you can contact the

SuMMiT-D team here:

(May add/delete contact info as applicable)

Interested in taking part?

Text Register and your full name (e.g. ‘Register John Smith’) to

XXXXXXXXXXX

Study Team (Oxford/Manchester)

Tel.: XXXXXXXXXX

E.: [email protected]/[email protected]

Study Address:

SuMMiT-D (Address Line 1) (Address Line 2)

(Post code)

http://www.summit-d.org

OUR COLLABORATORS

3. summit-d pil v1.0 25-jun-2020...2020/06/25 · summit-d participant information leaflet version...

Documents