Plain Language Information Statement
Plain Language Information Statement
A randomised controlled trial and consumer characteristics of iChooseWell: A comprehensive biopsychosocial digital health wellbeing program.
Professor Britt Klein: School of Health Sciences and Psychology, Centre of Biopsychosocial and eHealth Research & Innovation
Other / Student Reseachers:
Brooke Andrews: School of Health Sciences and Psychology; 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 iChooseWell 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, strategy-based wellness program designed to improve wellbeing and decrease stress. This program was developed using evidence-based techniques and it is designed to help people better deal with 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 digital 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 iChooseWell program.
Participants will be asked to:
- Create a ‘My Digital Health’ platform (the iChooseWell 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 iChooseWell program. Here you will need to agree to participate in the iChooseWell 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., how optimistic you are, how stressed you feel, the strategies that you use to deal with emotional and stressful situations, time perception). The pre-intervention questionnaires should take approximately 25 minutes to complete.
- Consent to be randomly allocated to either the immediate access or delayed access (delayed by 8 weeks) to the iChooseWell program groups.
- Immediate Access. You will receive immediate access to the iChooseWell after completing the pre-program questionnaires. The program consists of key health educational information and a choice between 42 wellness enhancing strategies; each strategy will take about 5 minutes to read and 10 minutes of activities (e.g., guided mindfulness based audios). Which wellness strategies and the number of strategies you do is entirely your choice.
- Delayed Access. If you are randomly assigned to the delayed access condition you will be asked to complete all the same online questionnaires, but will have to wait until the 1 month follow-up (start of Week 9) to access the program.
- 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. If you have a Fitbit device, you are also able to integrate it to the iChooseWell program to record your sleep, heart rate and number of steps per day.
- Complete two questionnaires (e.g., how optimistic you are feeling) at the start of Week 3. This should take 3-5 minutes to complete.
- Complete the post program questionnaires in Week 5, again asking you about your mental health and wellbeing. However for those in the immediate access group, we will also ask you about your satisfaction with the iChooseWell program. This should take you about 25 minutes to complete.
- Complete the 1 month follow-up questionnaires at Week 9, which also ask you about your mental health and wellbeing. Once completed, the delayed access group will then be able to access the iChooseWell program and will be asked to complete the post program questionnaires in Week 13, again asking you about your mental health and wellbeing and satisfaction with the iChooseWell program. These questionnaires should take you about 20 minutes to complete.
- Both groups will then be asked to complete one more follow-up questionnaire survey in Week 17, once again asking you about your mental health and wellbeing. These questionnaires should take you about 20 minutes to complete.
The wellness strategies based iChooseWell program will record your usage of the program (e.g., how many times you logged in, the amount of time spent using the program). This information will not affect your use of the program. You will also be sent automated reminder emails during your 17 weeks while being involved in this study. You will be able to continue to access the iChooseWell program for another 4 weeks following your last follow-up assessment in Week 17.
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, subject to legal limitations, and stored securely using the ‘My Digital Health’ platform and linked survey management tool utilising the platforms 256-bit encryption SSL security certificate and can only be accessed by the investigators. When analysing any data, any identifying information will be 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?
iChooseWell is a wellness strategies-based, user friendly and interactive program that you should find enjoyable. More importantly, you will acquire skills and knowledge of a way to 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 iChooseWell program, please contact a GP or Lifeline (available 24 hours a day: 131 114).
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 ‘A randomised controlled trial and consumer characteristics of iChooseWell: A comprehensive biopsychosocial digital health wellbeing program’, or a summary of the results once the study is completed, please contact the Principal Researcher, Professor Britt Klein of the School of Health Sciences and Psychology: Phone: 03 5327 6717, EMAIL: firstname.lastname@example.org
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: email@example.com
CRICOS Provider Number 00103D
© 2020 MY DIGITAL HEALTH