STUDY TITLE: Skin Selfie - a self-monitoring mobile phone application for skin conditions
You are being invited to participate in a research study about monitoring changes in skin conditions using a new mobile phone application (app) called Skin Selfie (http://www.myskinselfie.com/).
Before you decide whether or not you wish to take part, it is important for you to understand why the research is being done and what it will involve. Please take your time to read the following information. Please ask the research doctor or nurse if there is anything that is not clear of if you would like more information.
With the improvements in mobile phone technology it is now easy to take high quality images and upload them rapidly to secure storage via the internet. We are in the early stages of testing a new mobile phone app for skin monitoring and want to find out how easy patients find it to use and how useful it is. Future versions may include the ability to share images with Doctors to reduce clinic visits but in this first phase of research we just want to see how well the app works for taking pictures and self-monitoring.
This study has been reviewed by the Newcastle and North Tyneside 1 Research Ethics Committee.
Our team at Newcastle University and the Royal Victoria Infirmary have designed and built a mobile phone app to help patients to monitor their skin conditions. The app has features to improve reproducibility of images. All images are dated and can be labelled. No images are stored on the normal camera roll improving privacy and are instead immediately stored on our secure encrypted storage servers .We are now aiming to carry out a study to investigate how easy the app is to use and whether or not patients think it is helpful in monitoring their skin condition.
You have been chosen because you have a skin condition or are receiving a treatment that may benefit from monitoring. You have also been chosen because you have a smartphone with a camera which either runs the Android or Apple operating system.
No, taking part is entirely voluntary and your decision will have no consequences. Your clinical care will not be affected by your decision to participate or not to participate.
We will ask you to read and sign a consent form. You will then need to download the app and follow the instructions on how to use it. You will then use it for 3 to 6 months and complete a questionnaire about the app at the end of the research. You will also complete a quality of life score which will give us a measure of how much your skin disease is affecting your life. We will ask you to use the app to monitor your skin condition. We will not give specific instructions on how often to use it as we are interested to know how often users want to use the app. The app does not affect how the phone camera works.
Taking part in this study will have no effect on the care that you get for your Dermatological problem. You will continue to attend clinic as many times as you need to.
At the end of the study we will look at how participants have used the app and invite certain users to attend for face to face interviews to discuss what they thought was good or bad about the app. The interview will require a second consent form to be signed and you do not have to take part if you choose not to. The interviews will take 30 minutes.
Yes, when you consent to take part in the study you will be assigned an anonymised study number. In this study none of the pictures that you take will be viewed by any of the researchers. The images are encrypted and stored on the server in an encrypted format. They are de-crypted for viewing when you open the app on your phone.
All your data will be stored in accordance with the Data Protection Act 1988. Your data will be held on a secure password protected NHS database in the Dermatology research office at the Royal Victoria Infirmary. Only the research team and approved regulatory personnel will have access to your records and medical notes. If the study results are published, the published report will not include identifiable data, and no content in the publication will be traceable to you. The study is indemnified by the Newcastle Upon Tyne NHS Hospitals Trust.
The app works best when used with a wifi link. Due to the encryption and data storage on the server it can cause delays to use the app on a 3G link. You must also remember that if you use the app on a 3G or 4G link this will have an impact on your data plan and will cost money. Each use of the app when not on wifi will normally use approximately 0.02MB from your data allowance and worst 0.5 MB depending on how much data is downloaded from the server.
When using MySkinSelfie the camera on your phone is not affected in any way. The camera software is not affected.
The instructions for using the app are contained within the app and you will see how it works when you download it. We will also provide you with an instruction sheet which is also available on the website, http://www.myskinselfie.com.You will also be able to ask questions whenever you need to by talking to members of the research team.
You can withdraw from the study at any time. I you wish to do so, you only need to notify the research team. Any data collected about you will not be used in the study and will be discarded safely.
If you have a complaint about the study you can speak to the research staff or the Principle Investigator of the study. The telephone number is 0191 2823568. If you are still unhappy you can contact the Patient Advice and Liaison Service (PALS) office. PALS is open on all weekdays except Bank Holidays on a drop-in basis. A messaging service is available out of hours. Tel: 0800 0320202, email: firstname.lastname@example.org, Text/SMS: 01670511098.
This research is being funded by a Digital Civics grant. The research is being coordinated and sponsored by Newcastle University and the Dermatology Department at the Royal Victoria Infirmary. The website for MySkinSelfie is http://www.myskinselfie.com. Further information about the app and the team that created it can be found there.
Dr Philip HAMPTON
Dermatology Outpatient Unit
New Victoria Wing
Royal Victoria Infirmary
Newcastle on Tyne
Telephone: 0191 2823568 (Research Office)
Contact: For questions or concerns relating to participant information leaflet, we can be contacted at: admin@MySkinSelfie.com.
Effective Date: This Participant Information Leaflet was last updated on 11th October 2016.