Plain Language Information Statement
Plain Language Information Statement
An ‘open study’ evaluation trial of the iSleepWell digital health program for insomnia and stress symptoms.
Professor Britt Klein: DVC-R Portfolio
Other / Student Researchers:
Professor Suzanne McLaren: School of Health & Life Sciences; Owen Cole: DVC-R Portfolio; Dr Cameron Foale: Faculty of Science & Technology; Asher Leslie & Lewis Lakerink: Technical Consultants to project.
Thank-you for your interest in the iSleepWell digital health program study. We invite people who are aged 18 years and over, who have access to the internet, to participate.
What is the project about?
This project seeks to determine the benefits of the comprehensive, cognitive behavioural and biopsychosocially-focused insomnia program designed to improve sleep and wellbeing and decrease stress. This program was developed using evidence-based techniques and it is designed to help people better deal with insomnia and stress symptoms, as well as everyday situations, and to enhance their mental and physical wellbeing.
The results from this project will be used by the researchers in the development of future health and wellbeing programs that will be made available to the general public.
What does this project involve?
The project involves collecting various pieces of information from you and your usage of the ‘iSleepWell’ My Digital Health program.
Participants will be asked to:
- Create a ‘My Digital Health’ platform (the iSleepWell digital health program is one program amongst others that are housed within the ‘My Digital Health’ platform) account if you do not currently have one. This will involve providing an email address, username and strong password. Once you have completed this, you will receive a confirmation email that you will need to verify before you can proceed any further. If you would like to remain anonymous, we suggest you use an email address that does not contain your first and last name.
- Once you have created a My Digital Health account, you can then re-enter the platform and sign up specifically for the iSleepWell program. Here you will need to agree to participate in the iSleepWell digital health study after reading through this Plain Language Information Statement and by clicking the “I agree to the above conditions” button below.
- Complete the pre-program questionnaires via this website. The questionnaires will ask you questions about yourself, including demographic details (e.g., age) and questionnaires asking you about your mental health and wellbeing (e.g., your insomnia symptoms, how stressed you feel, the strategies that you use to deal with emotional situations, time perception). The pre-program questionnaires should take approximately 35 minutes to complete.
- Receive immediate access to the iSleepWell digital health program.
- You will receive immediate access to the iSleepWell program after completing the pre-program questionnaires. The program consists of six modules; each module will take about 25 minutes to read and 30 minutes of offline activities (e.g., guided mindfulness based audios).
- Complete a daily mood and lifestyle web or mobile survey (e.g., average anxiety rating) (should take about 30 seconds) so you can monitor your progress graphically through your program dashboard. This will allow you to self monitor your mental health and wellbeing more efficiently. If you have a FitBit device, you are also able to integrate it to the iSleepWell digital health program to also record your sleep, heart rate and number of steps per day.
- Complete three questionnaires (e.g., your sleeping patterns and psychological distress) at the start of Week 2, 4 and 6. This should take 3-5 minutes to complete.
- Complete the post program questionnaires in Week 8, again asking you about your mental health and wellbeing and we will also ask you about your satisfaction with the iSleepWell program. This should take you about 30 minutes to complete.
- Complete the 1 and 3 month follow-up questionnaires at Week 12 and Week 20, which also ask you about your mental health and wellbeing. These questionnaires should take you about 25 minutes to complete.
You are also able to request that we add your nominated healthcare practitioner to your program account (providing you and your practitioner reside in Australia). Your healthcare practitioner must be a qualified healthcare professional (e.g., psychologist, general practitioner) and you must first discuss this matter with them before completing the request form. You can access this request form by clicking the ‘Connect to Practitioner’ button on your program dashboard.
Adding your healthcare practitioner means that they will be able to view a copy of the iSleepWell program and you can communicate with them through our communication system (internal email, instant messaging, shared collaborative workspace, video-chat). We will only use the metadata created by you and/or your healthcare practitioner (e.g., how many internal emails you and your healthcare practitioner sent to each other, how many times you used the video-chat system). No text, video or audio content will be used or analysed. You are also able to specify whether they can view your account activity, progress graphs and self-monitoring data. You can also revoke their access by letting us know (i.e., ‘Contact Us’ form, internal email). Should you (or your healthcare practitioner) wish to stop interacting through your iSleepWell program account, we will inform your healthcare practitioner (or you) of this.
The iSleepWell digital health program will record your usage of the program (e.g., how many times you logged in, the amount of time spent using the program), whether you have added your nominated healthcare professional and the metadata related to this use (e.g., how many times you used My Digital Health to communicate with your healthcare practitioner [e.g., number of emails sent, number of video-chats conducted]). This information will not affect your use of the program. You will also be sent automated reminder emails during your 20 weeks while being involved in this study and alerts should your mood scores decline. You will be able to continue to access the iSleepWell program for another 8 weeks following your last follow-up assessment in Week 28.
Can I withdraw from the project?
Participation in this project is completely voluntary. If you decide you do not want to continue with the project, you can withdraw at any stage of the intervention and follow up, without having to provide any explanation. Your withdrawal will have no impact on current or future relationships with Federation University.
What will happen to my results?
All information will be strictly confidential, yet subject to legal limitations (e.g., legal subpoena) and only be assessed by the investigators. Data is stored securely and we use 256-bit encryption Secure Sockets Layer and Transport Layer Security (SSL/TLS) software when information is transmitted. If you request the addition of your healthcare practitioner, you will also be asked what data they can view (i.e., access to your progress graphs, daily self-monitoring and account activity data). You can revoke their access to this data at any time. When we analyse any data, any identifying information is completely removed and therefore cannot be linked back to you in any way. Your de-identified data may be used for research projects into the future. All data will be stored securely for five years after any publications. After this time the data will be destroyed. Any publications or thesis produced arising from the results from this study will only use aggregate, or group data sets. As the data are analysed without any identifiable information, and as publications will report findings based on group data, individual participants will not be identifiable in any way.
How will the project benefit me?
The iSleepWell program for insomnia and stress, is a user friendly and interactive program that you should find enjoyable. More importantly, you will acquire skills and knowledge of ways to improve your sleep and increase your wellbeing.
Are there any risks from participating?
No health risks are expected from participating in this project, however, you may feel slightly uneasy when answering questions about past experiences and your beliefs and attitudes. If you feel concerned or distressed in any way from completing any of the assessments or using the iSleepWell program, please contact a GP or Lifeline (available 24 hours a day: 131 114).
Please note, if you opt to add your healthcare practitioner, please be aware that broadband speed, device and browser type can interfere with your connection. We recommend that you use a Firefox or Chrome browser, via a desktop computer or laptop device with good internet speed, for best results. Additionally, as we are not offering this service to you commercially, we cannot guarantee continuous uninterrupted service. It is important therefore that you have an alternative means by which to communicate with your healthcare practitioner, should service to the communication system be interrupted or you experience internet wifi or broadband coverage issues.
How do I participate?
Having read this Plain Language Statement and decided that you would like to participate in this project, please click on the “I agree to the above conditions” button below on your computer screen. Once you consent, the project will commence as outlined above (completion of the pre-program questionnaires). If you do not wish to participate in this study, please click the “I decline to participate” button and you will be taken back to your dashboard where you are able to choose another digital program, if you wish.
If you have any questions or would like further information regarding the project titled ‘An ‘open study’ evaluation trial of the iSleepWell digital health program for insomnia and stress symptoms’, or a summary of the results once the study is completed, please contact the Principal Researcher, Professor Britt Klein of the DVC-R Portfolio: Phone: 03 5327 6717, EMAIL: email@example.com
This research study has been approved by the university’s Human Research Ethics Committee. Should you (i.e. the participant) have any concerns about the ethical conduct of this research project, please contact the Federation University Ethics Officer, Research Services, Federation University Australia, PO Box 663, Mt Helen VIC 3353. Telephone: (03) 5327 9765, Email: firstname.lastname@example.org
CRICOS Provider Number 00103D
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