RAPapp study: Participant Information

The RAPapp Study: Rest-Activity Patterns and their links with Sleep and Health

Participant Information

You are being invited to contribute to a research study looking at the links between changes in when or how much people are physically active during the COVID-19 pandemic related lockdown measures, and health.

Before you decide whether to take part, it is important for you to understand why the research is being conducted and what it will involve. Please take as long as you want to read the following information before deciding whether to take part; and discuss it with others if you wish.  Please contact us if there is anything that is not clear or if you would like more information. Thank you for taking the time to read this.

About the research

  • Who will conduct the research?

The research is being conducted by Sophie Faulkner, Emily Eisner, Richard Drake, (School of Health Sciences, University of Manchester / Greater Manchester Mental Health NHS Foundation Trust), Derk-Jan Dijk (Sleep Research Centre, University of Surrey), Adrian Harwood (Research IT, University of Manchester), Stephanie Allan (University of Glasgow), and Rory Byrne (Psychosis Research Unit, Greater Manchester Mental Health Trust).

  • What is the purpose of the research?

This research will look at the links between rest-activity patterns with sleep and health, during social distancing and lockdown measures.  We hope to find out more about particular changes in activity timing or intensity, that might be helpful or unhelpful for sleep and health.  We are also interested in what people think about seeing a plot of their rest activity patterns, and how these graphics could be useful.  We hope our findings will help to better understand, and improve, sleep and health interventions and self-help advice.  This might help people who have to ‘shield’ themselves, and people with other health conditions that affect their ability to go out generally (at other times apart from during the pandemic).

We are examining rest-activity patterns by looking at Withings Health Mate activity tracking data (step tracking using wearables or smartphones), before and during lockdown, and as lockdown is being eased.  We are also asking survey questions to help us interpret the activity data, and (separately) asking people for their views on these rest-activity pattern plots (which show the pattern of when people were still and active visually).

As well as answering research questions about activity, sleep and health, we aim to create a large shareable dataset of anonymous data, that can be used to answer other questions by other researchers.

  • Will the outcomes of the research be published?

The results of the study will be published in a peer reviewed academic journal, as well as in shorter forms online (such as a blog or podcast).  We will be publishing rest-activity pattern plots and study updates as we go along, you can view them here.  If you want to be emailed with a summary of the findings please email us with the subject line ‘SEND FINDINGS’ ([email protected]).

  • Who has reviewed the research project?

The project has been reviewed internally within the research team, by patient and public involvement contributors, and by The University of Manchester Proportionate Research Ethics Committee (reference####).

  • Who is funding the research project?

This research is funded by the National Institute of Health Research (NIHR), the research section of the NHS (Award number: ICA-CDRF-2016-02-007).

Who can contribute?

Anyone who is using the Withings Health Mate app can contribute data.  This might be users of Withings devices such as activity tracking watches and sleep sensors, or phone step-tracking using Health Mate app.

Due to ethical restrictions we can only accept contributions from people over 16 residing in the European Economic Area (all countries in the EU, the UK, Iceland, Lichtenstein and Norway).

How can I contribute?

You can contribute by sending Withing Health Mate data and answering questions, by analysing rest-activity pattern plots, or by helping to share our study so that more people see it.

  • Contributing your Withings Health Mate activity tracker data and answering questions – what would I be asked to do?

To contribute your activity data you need you to download your Withings Health Mate data file (instructions are here, and in RAPapp), and download the Rest-Activity Pattern app (RAPapp) from the Google Play Store or the Apple Store.

RAPapp will take you through some brief survey questions (takes about 6 minutes), and then ask you to upload your Health Mate data file.  RAPapp will then build your rest-activity pattern plot from your data, brighter green shows more steps or activity.  You can zoom and scroll using the controls provided, save your plot, and share your plot if you wish.

If you want to participate again later to update your data, you are very welcome to, and we would love to have your updated data!  You will be asked fewer survey questions if you are re-participating.

  • Inviting others

We need a lot of data from a lot of people, it will really help if you share the study on social media, or invite friends or family members to contribute!   ###share button/link here####

  • Analysing your own plot

Optionally, you will be given the option to comment on your plot, on things you notice, that you find surprising, or not, and anything you feel explains your plot.  You don’t need special training to do this, you can comment based on whatever your level and areas of knowledge are.

  • Analysing the rest-activity pattern plots we publish as we go along

We are interested in the community response to the rest-activity pattern plots we publish as we go along (view here), including what you think affects these rest-activity patterns, and visual similarities and differences community contributors can see between different plots, to further involve members of the public.

You can also comment on questions you think this data could be used to answer, and we will publish a summary of these ideas which other researchers can use as inspiration for further analysis of this data, or other future studies.  You can contribute to this whether or not you are contributing your own activity data (this part is as public involvement in research, rather than research participation).

  • Will I be compensated for taking part?

There is no payment for taking part, and taking part should not cost you any money either.

  • How will you protect my data?

Your participation is anonymous, we will not collect any data that identifies you.  Your Withings data will tell us your time zone, but we are not collecting any GPS data.  If there is GPS data in your file, or free text comments you wrote within Health Mate, these will not be sent by RAPapp, so it will never leave your phone and we will not have access to it.  We are not collecting any personally identifiable data.

The only way it would be possible for a person to identify your data is if you share or have shared timed dated activity data to a public forum (such as social media).  We will not seek to identify contributors.  For this reason though we will treat individual survey responses linked to activity tracking data as ‘safeguarded’ data, requiring authentication of any future researchers, and agreements regarding terms of use.  This will include that future uses must be non-commercial, for health and wellbeing research, and with agreement that researchers will not seek to identify contributors.

  • What happens if I do not want to take part or if I change my mind?

It is up to you whether you take part, and because we are not collecting any personally identifiable data we will not know who has taken part.  Once you have taken part you will not be able to withdraw your data or delete it from the dataset, as we are not able to identify it.

  • Will I be compensated for taking part?

There is no payment, but you will get your rest-activity pattern plot, and to support science!

Data Protection and Confidentiality

  • What information will you collect about me?

Information which could identify you is called ‘personal identifiable information’, we are not collecting any personal identifiable information.  You remain anonymous.

If you participate by sending data we will collect:

  • Your activity, steps and sleep data as collected in the Health Mate app (step count per minute, automatically detected activities like running or swimming, and ‘sleep state’ data).
  • If you have entered your height or weight, Health Mate will include this information.
  • General working situation (e.g. working from home, not working, going out for work)
  • Your ratings relating to your sleep, overall health, and depression and anxiety, and daylight exposure.
  • Living situation (urban vs rural, and access to outdoor space).
  • Current and past self-isolation and shielding status (not exact dates or symptoms)
  • Caregiving responsibilities (Yes / No, a lot / somewhat)
  • Age, gender and country of residence.
  • The option ‘prefer not to say’ is provided in the cases of age, gender and country.
  • Your comments relating to your sleep and activity.
  • All questions are optional.
  • Will my participation in the study be confidential and the data I have contributed be protected?

In accordance with data protection law, The University of Manchester is the Data Controller for this project.  This means that we are responsible for making sure and potentially identifiable information is kept secure, confidential and used only in the way you have been told it will be used. All researchers are trained with this in mind, and your data will be looked after in the following way:

Provide details of:

  • Firstly by avoiding collecting personal identifiable data.
  • And secondly by treating survey data linked to rest-activity data as ‘safeguarded data’, due to the potential for a person already possessing some detailed rest-activity data to use this to identify the owner of that data.  Treating this as ‘safeguarded data’ means that any future researcher applying to access the data would be required to undergo validation and make agreements regarding the use of this data.

Where will data be held:

  • Data will be transferred from the contributor’s mobile device to StorageConnect (a University of Manchester app data transfer system), and from there to the University of Manchester’s Research Data Storage system.
  • Data will be stored for over 20 years.
  • Data will not be transferred outside the EEA or to any cloud services
  • We will share data with Stephanie Allan of University of Glasgow via secure University of Manchester approved methods
  • We will store the data collected for use in other research, in line with open data initiatives.
  • We will only have your contact details if you have contacted us (contact details are not collected during participation), in which case we will only use these as you have requested in your contact.

Sharing data:

When you agree to take part in a research study, the information about you may be provided to researchers running other research studies.  Rest-activity pattern data, and a summary of the survey responses (no individual responses) will be shared via a repository, with individual responses being treated as safeguarded data.    Data will only be released to researchers to conduct research in accordance with The University of Manchester’s Research Privacy Notice.  The future research will be of a similar nature to this research project and will concern health and wellbeing, rest-activity patterns, sleep, and pandemic mitigation measures.

This information will not identify you and will not be combined with other information in a way that could identify you.  The information will only be used for the purpose of health and wellbeing research, does not include contact details, and cannot be used to make decisions about future services available to you.

If you have contacted us to request a study summary we will only keep your contact details long enough to provide this, unless you later request us to keep them for longer for any other purpose.

Please also note that individuals from The University of Manchester or regulatory authorities may need to look at the data collected for this study to make sure the project is being carried out as planned.  All individuals involved in auditing and monitoring the study will have a strict duty of confidentiality to you as a research participant.

 

What if I have a complaint?

Please contact Richard Drake: [email protected]

If you wish to make a formal complaint to someone independent of the research team or if you are not satisfied with the response you have gained from the researchers in the first instance then please contact

The Research Ethics Manager, Research Office, Christie Building, The University of Manchester, Oxford Road, Manchester, M13 9PL, by emailing: [email protected]  or by telephoning 0161 275 2674.

Contact Details

If you have any queries about the study you can contact the researcher

Sophie Faulkner and the study team email: [email protected]

Sophie’s RAPapp study phone: 07734 516 593

 

To download RAPapp  from the app store if you have not already:

For android: https://play.google.com/apps/testing/uk.ac.manchester.rapapp

For apple: https://testflight.apple.com/join/S3w8yLdK

Participant Information, Version 2; 24/08/2020