PARTICIPANT INFORMATION SHEET

Measurement of treatment burden experienced by individuals with long-term health conditions.

The study is conducted by student researchers Andleeb Arshad and Carlotta Schwertel under the supervision of Corina Weir.

You are invited to take part in a research study to investigate treatment burden in relation to medical conditions. Before you decide to take part, it is important that you understand the purpose and scope of the study. Please read the below information carefully and if necessary discuss with others, such as your relatives. If anything is unclear, please ask for more information. Take time to decide whether you wish to participate. Thank you for reading this information sheet.
1. What is the purpose of the study?
Living with one or more medical conditions can require effort to control the impact this can have on daily life. With the increasing demands on healthcare systems and a shift towards self-management of chronic conditions, treatment burden has increasingly become the focus of research. Treatment burden relates to the strain individuals feel when managing health conditions. This can include, but is not limited to, understanding information on conditions and treatments, taking medications, dealing with side effects, attending appointments, relationships with professionals and support from family members and friends.
The purpose of this study is to compare the small number of existing measures on treatment burden. These measures vary in length, content and aspects of treatment burden they cover, and we want to investigate whether these questionnaires accurately measure treatment burden.
2. Why have I been chosen?
We are looking to ask 180 people to take part, specifically individuals who suffer from one or more long term health conditions which they have been managing on a day to day basis over the last six months.
3. Do I have to take part?
No, it is entirely your decision  to take part in the study.  If you decide to take part, you will be  asked to complete a consent form. You can withdraw from the study at any point, and you will be given a unique code to keep in case you wish to withdraw your data from the study. We will ask you to keep a note of this, and you will be able to withdraw your data up to the 22nd of July 2020. If you contact us by email after this date, we will not be able to withdraw your information as it will be written in a report by then.
4. What will happen to me if I take part?
If you decide to take part, you will be requested to complete a consent form, demographic sheet and a set of three questionnaires. This will take approximately 30 – 40 minutes in total.  The demographic sheet includes personal information of the participant such as age, gender, ethnicity, education level and employment status.
After completing the questionnaires, you will be asked for your email address so you can enter a prize draw. This is entirely optional, and your email address would only be used to contact you if you are successful in winning the £40 Amazon voucher.
5. What are the possible disadvantages and risks of taking part?
There are no anticipated disadvantages of taking part in this research, and if you do wish to discuss treatment burden further, we advise that you contact your GP. There are contact details for the research team at the end of this sheet if you would like to discuss anything further regarding this study.
6. What are the possible benefits of taking part?
While there are no specific direct benefits to yourself for taking part in this study, your participation will provide us with valuable information about the suitability of the current measures of treatment burden. This may lead to a deeper understanding of people’s experience of treatment burden and the possible creation of a comprehensive questionnaire which will enable healthcare professionals to identify and support those who struggle with managing their medical conditions.
7. Will my taking part in this study be kept confidential?
Yes, your participation will be kept strictly confidential. You will not be identified in any reports or publications. The online data will be stored electronically on University of Aberdeen password protected computers, in a secure folder which only the student and supervisors have access to. Data will be retained and archived for 10 years in accordance with the University of Aberdeen Standard Operating Procedures. The University of Aberdeen is the sponsor for this study based in the United Kingdom. We will be using information from you in order to undertake this study and will act as the data controller for this study. This means that we are responsible for looking after your information and using it properly.
We need to manage your records in specific ways for the research to be reliable. This means  we won’t be able to let you see or change the data we hold about you. To safeguard your rights, we will use the minimum personally identifiable information possible.
8. What will happen to my data?
We will need to use the information you provide for the write up of the student researchers' Masters thesis. This information will include your demographic information and responses to questionnaires about treatment burden. We will keep all the information you provide securely, and we adhere to the University of Aberdeen data storage policies. People who do not need to know who you are will not be able to see your name or contact details. You will come up with a unique identification code, solely to allow you to withdraw your details if you wish to do so before data analysis.

Once we have finished the study, we will keep some of the data so we can check the results. We will write our reports in a way that no one can work out that you took part in the study.
You can find out about how we use your information by contacting: Iain Gray, University of Aberdeen, Data Protection Officer at http://www.abdn.ac.uk/privacy or on 01224272596 or by contacting data protection office dpo@abdn.ac.uk.

Who is Funding the Research: This study is funded by the University of Aberdeen.  
This study has been reviewed by the Ethics Review Board of the College of Life Sciences and Medicine of the University of Aberdeen.
Contact for Further Information
If you have any other queries, please feel free to contact the Health Psychology research team.

Andleeb Arshad and Carlotta Schwertel (Student researchers)                            
a.arshad.19@abdn.ac.uk ; c.schwertel.19@abdn.ac.uk

Corina Weir (Supervisor)
corina.weir@abdn.ac.uk

If you wish to make a complaint about the study, please contact:
University of Aberdeen & NHS Grampian Clinical Research Governance,
Foresterhill House Annexe, Foresterhill,
Aberdeen, AB25 2ZB

researchgovernance@abdn.ac.uk

The above contact is not part of the research team.
 
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