King’s College London – ADHD Fitbit Research Collaboration

• Adolescence can be a challenging period for young people with ADHD, with major life transitions, new demands, and increased expectations.
• King’s College London seek to study young people with ADHD in their transition into adulthood using a Fitbit and smartphone app. The researchers aim to investigate the changes that takes places, what predicts these changes, and how can they prevent negative outcomes and support healthy lifestyles.
• If you and your parents decide to take part (100% optional), you would:
  • Attend two virtual sessions with a member of their research team
  • Be provided a Fitbit and Android phone (which you can keep after the study ends)
  • Have your heartrate, sleeping patterns and other metrics collected over a two-year period
• A subgroup of participants will also be asked (100% optional) to take part with King’s College London in the co-design of a prototype for a new smartphone app meant to help support young people with ADHD.

• Yes, if you and your parents consent.
• To be eligible you need to be 16 or 17 years old and have a diagnosis of ADHD.

• No. Participation is 100% optional.
• You do not have to take part, and if you do decide to participate, you are free to withdraw from the study at any time, without giving a reason.
• Whether or not you and your parents decide to take part will not affect the healthcare you receive in any way.

• If you and your parents decide to participate in in this project, you would need to sign a consent form first.
• You would then be invited to attend two virtual baseline assessments, seven days a part, with a member of the research team from King’s College London.
• Each virtual baseline assessment would take around 1.5 hours.

First Baseline Assessment

• Begins with an interview with a King’s College London research worker to confirm a diagnosis of ADHD. They will also ask you to ask a parent/guardian, to contact the study team to complete two web-based questionnaires about your behaviours every four weeks.
• King’s College London would then send you the mobile device and the wrist-worn Fitbit device, both of which you can keep when the study ends.
• The wrist-worn wearable device will passively collect info about your movements and heart rate. From this information, the researchers will be able to calculate your levels of physical activity and sleep patterns.

Second Baseline Assessment

• You would then attend a second virtual baseline assessment where King’s College London will spend some time explaining how these devices work, and how to use the smartphone apps. You will also perform two tasks on a computer that measure attention and speed of responses.

Receiving your Fitbit and Android Phone

• You will be asked to carry the study smartphone with you at all times for the duration of the study. In this study King’s College London are using Android phones: they will give you one (which you can keep after the study ends).
• During the study period, they will ask you to keep your normal daily routine.
• The apps will send you notifications to fill in some questions on the smartphone about your behaviours, mood, and medication use. You will also be asked to complete other questionnaires once a month and the cognitive tasks every 6th month. The researchers would also ask you to record two short speech tasks every four weeks.
• King’s College London will organise a phone call or online meeting with you. This will help them to understand what they can do better in the future.

Further (100% optional) subgroups

• In addition, a subgroup of participants will be invited (100% optional) to complete a longer qualitative interview investigating your experiences of using remote technology.
• A second subgroup of participants to will also be invited (100% optional) take part in the co-design of a new smartphone app for young people with ADHD, involving taking part in online individual and group-based interviews to provide feedback on design ideas, app features and functions.

• King’s College London is the sponsor for this study where specialist teams continually assess and ensure that data is held in the most appropriate and secure way. To safeguard your rights, they will use the minimum personally-identifiable information possible.
• Information from the wearable and smartphone apps will be encrypted (scrambled). Your information will only be used by researchers to conduct research in accordance with the UK Policy Framework for Health and Social Care Research.
• You can voluntarily withdraw from the study at any time without providing a reason.

• You will receive £30 from King’s College London every third month of your study participation (£240 in total for 24 months). In addition, at the end of the study, you can keep both the smartphone and the fitness tracker.

• The wrist-worn wearable used for this research project is very safe; it is a commercially available device and has therefore undergone extensive safety testing.
• There is a very small chance you may develop a skin rash where it is worn, in which case you can remove it.

• Participating in research can be rewarding, and you will be contributing to the development of new knowledge and new measures which could benefit other people with ADHD in the future.
• It’s important to understand that participating in this study will not cure or treat your ADHD.

• The results of this study may be presented at conferences, and may be published in scientific journals, published in other publications (e.g. textbooks), published on websites (e.g. blogs), presented at research clubs, and included in dissertations.
• You will not be identified personally in any report or publication.

• King’s College London would need to use information from you for this research project.
• Your data will have a code number instead. King’s College London will keep all information about you safe and secure.
• King’s College London will write their research reports in a way that no-one can work out that you took part in the study.

• You can stop being part of the study at any time, without giving a reason.

• All research in the NHS such as this research, is looked at by an independent group of people, called a Research Ethics Committee, to protect your interests. This study has been reviewed by the Nottingham Research Ethics Committee.

• If you have any questions or difficulties relating to the study which you would like to discuss, please email research@dr-giaroli.org