Plain Language Information Statement
Plain Language Information Statement
MonitorMe: An open trial of an interactive biopsychosocial self-monitoring digital health program with decision support, timely strategy information and tools.
|Principal Researcher:||Professor Britt Klein: DVC-R Portfolio|
Other / Student Researchers:
|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 MonitorMe 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 an interactive biopsychosocial self-monitoring digital program called MonitorMe to assist in keeping track of mood and lifestyle behaviours. This program was developed using evidence-based techniques and it is designed to help people better deal with symptoms of stress, anxiety and low mood, as well as 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 digital health 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 ‘MonitorMe’ My Digital Health program.
Participants will be asked to:
- Create a ‘My Digital Health’ platform (the MonitorMe 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 MonitorMe program. Here you will need to agree to participate in the MonitorMe digital health study after reading through this Plain Language Information Statement and by clicking the “I have read the Plain Language Information Statement and I agree to the above conditions.”
- Complete the pre-program survey 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., how stress and anxious you are, the strategies that you use to deal with emotional situations). The pre-program survey questionnaires should take approximately 35 minutes to complete.
- Receive immediate access to the MonitorMe digital health program. The program consists an interactive biopsychosocial self-monitoring tool, decision support tools (to assist you when looking at your self-monitoring data every 7 days), an Introduction module to help orientate you to the program, access to over 40 biopsychosocial mini strategy life skills modules and practice tools, information emailed to you following completion of the scheduled assessments regarding progress, as well as having the option of the platform monitoring your daily self-monitoring scores. Completing the daily self-monitoring survey will take you about 1 minute, the Introduction Module about 30 minutes and working through the self-monitoring decision support tool about 10-20 minutes per week. Should you wish to read over one of the mini modules, this should take you about 15 minutes to read.
- The daily mood and lifestyle events web or mobile survey (e.g., average anxiety rating) allows you to self-monitor your mental health and wellbeing more efficiently and if you have a Fitbit device, you are also able to integrate it to the MonitorMe digital health program to record your sleep, heart rate and number of steps per day.
- Complete three questionnaires (e.g., stress, anxiety and low mood) every 4 weeks at the start of Week 5, 9, 13, 17, and 21. This should take 5 minutes to complete.
- Complete the post program questionnaires in Week 25, again asking you about your mental health and wellbeing and we will also ask you about your satisfaction with the MonitorMe program. This should take you about 35 minutes to complete.
- Complete the 6-month follow-up questionnaires at Week 49, which also ask you about your mental health and wellbeing. These questionnaires should take you about 30 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 MonitorMe 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 MonitorMe program account, we will inform your healthcare practitioner (or you) of this.
The MonitorMe 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 49 weeks while being involved in this study and alerts should your mood scores decline. You will be able to continue to access the MonitorMe following your last follow-up assessment in Week 49 for two weeks.
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 program delivery and subsequent 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 data, any identifying information is completely removed and therefore cannot be linked back to you. Your data may be used for research projects into the future such as being re-analysed or added to other digital health data into the future to answer other research questions. Any other person, apart from current researchers, gaining access to the data, will only be supplied with de-identifiable data and can only receive it for a legitimate research purpose (e.g., data use for a future thesis project). Upon conclusion, the ‘other’ researcher will destroy the password protected, de-identifiable data file provided to them. All data will be stored securely for at least five years after any publications and later destroyed after that time. 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 MonitorMe program is a user friendly and interactive self-monitoring and information program that you should find enjoyable. More importantly, you will be able to monitor your mood and lifestyle events and acquire skills and knowledge ways to maintain or decrease symptoms of stress 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 MonitorMe program, please contact a GP or Life Line (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 when logged into My Digital Health and having selected MonitorMe. Once you consent, the project will commence as outlined above (completion of the pre-program surveys). 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 ‘MonitorMe: An open trial of an interactive biopsychosocial self-monitoring digital health program with decision support, timely strategy information and tools.’, 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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