Plain Language Information Statement

Healthcare Practitioner Version

Plain Language Information Statement

 

Project Title:

 

 

A randomised evaluation trial of the LIFE FLeX digital health and wellbeing program for anxiety and depression.

Principal Researcher:

 

 Professor Britt Klein: DVC-R&I Portfolio

 

Other / Student Researchers:

 

Professor Suzanne McLaren: School of Health & Life Sciences; Asher Leslie: DVC-R Portfolio; Dr Cameron Foale: Faculty of Science & Technology; Lewis Lakerink: Technical Consultant to project; Brooke Andrews: School of Health & Life Sciences; Lachlan Kent: School Health & Life Sciences (PhD Student).

 

 

Healthcare Practitioner Verison

 

Thank-you for your interest in participating in this digital health study. Your client is currently participating in the LIFE FLeX digital health study, which invites people from the general public, who are aged 18 years and over, experiencing anxiety and/or depressive symptoms and who have access to the internet, to participate.

Within this LIFE FLeX study, we have also provided a mechanism whereby participants can request for a ‘digital connection’ with their nominated healthcare practitioner through the platform. Practitioners need to be a qualified Australian healthcare practitioner and participants are asked to first confirm that they have discussed the matter with their healthcare practitioner before making the connection request.

 

What is the project about?

This LIFE FLeX digital health study itself seeks to determine the efficacy of the program and the factors that predict people’s use of it. LIFE FLeX is a seven-week self-help program designed to help people decrease their anxiety and depressive symptoms and increase wellness.

The results from this project will be used by Federation University researchers in the development of future digital health programs that will be made available to the general public, as well as in the partial fulfillment of Lachlan Kent’s PhD degree.

 

What does this project involve for the general public ‘consumer’ participant?

The LIFE FLeX project involves collecting various pieces of information from the general public consumer participant and their usage of LIFE FLeX program. Participants:

  • Will have created a ‘My Digital Health’ platform account and selected the LIFE FLeX study.
  • Will have agreed to participate in the LIFE FLeX study after reading through the Plain Language Information Statement (consumer version).
  • Will have completed the pre-program questionnaire survey via this website.
  • Will have been randomly allocated to one of two versions of LIFE FLeX: LIFE FLeX (Version A) or LIFE FLeX (Version B).
  • May be completing the daily mood and lifestyle monitoring digital survey (e.g., average anxiety rating) so they can monitor their progress graphically.
  • Will or have completed two questionnaires at the start of Week 3 and 5.
  • Will be asked to complete the post program questionnaires in Week 8 and
  • Will be asked to complete the 1 and 3 month follow-up questionnaires at Week 12 and Week 20.

 

What does this project involve for the nominated healthcare practitioner?

Your client has requested that we contact you, in order to add you to their LIFE FLeX program account. When making this request, they confirmed that they had discussed the matter with you and that you are a qualified healthcare professional (e.g., psychologist, general practitioner). Adding a healthcare practitioner to the My Digital Health platform means that you will be able to view a copy of the LIFE FLeX program (and other programs) and can communicate with your client using our communication system (secure email, instant messaging, video-chat, use of a private shared collaborative digital workspace). In addition, when making the request, your client also specified whether they consent to you viewing their program account activity, progress graphs and self-monitoring data. Access to this data (and this connection) can be revoked by your client at any time. Should your client wish to stop interacting with you through their LIFE FLeX program account, we will inform you of this.

The LIFE FLeX digital health program will record what type of healthcare practitioner you are and in which state you reside. We will only use the metadata created by you and/or your client (e.g., how many times you logged into My Digital Health, what digital health program pages you visited, how many internal emails you and your client sent to each other, how many times you used the video-chat system). No text, video or audio content will be used or analysed.

Once your client completes the LIFE FLeX program, we will invite you to briefly discuss your experiences of using My Digital Health with your client, via video-chat, email, telephone or questionnaire survey. If you choose to participate, your responses will be noted and analysed in a de-identified way.

 

Can I withdraw from the project?

Participation in this project is completely voluntary. If you decide you do not want to continue to interact with your client through My Digital Health, you can withdraw at any stage. To inform us of this, please use the internal email system or the ‘Contact Us’ form. We expect that you will have discussed this with your client before contacting us, but please note that we will also inform your client that we have removed this connection, upon your request. 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, can only be accessed by the investigators, yet subject to legal limitations (e.g., legal subpoena). Data is stored securely and we use 256-bit encryption Secure Sockets Layer and Transport Layer Security (SSL/TLS) software when information is transmitted. When analysing any data, any identifying information will be completely removed and therefore cannot be linked back to you in any way. Only your de-identified meta-data (e.g., number of log ins but not any ‘healthcare practitioner-client’ communication content [e.g., text information sent or received within emails]) and your platform ‘experiences’ data may be used for research projects into the future. The data will be stored securely for five years post any publications. After this time the data will be destroyed safely. 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?

You will be given free access to the My Digital Health platform being able to view our My Digital Health digital health programs and have a secure and direct connection with your client. Here you will be able to securely communicate with your client via email, instant messaging and audio/video-chat. Providing your client has consented, you will also be able to view their progress graphs, account activity and self-monitoring data.

 

Are there any risks from participating?

No risks are expected from participating in this project. However, please be aware that broadband coverage, 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 broadband width, for best results. Please note, 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 client, should service to the communication system be interrupted or if 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, we will ask you to verify your consent, verbally or electronically. Once you have consented, we will send you an My Digital Health invitation email. This email will provide you with instructions around how to create an account and again, stipulated that by creating this My Digital Health account, you are agreeing to the My Digital Health ‘Terms of Use’, ‘Privacy Statement’ and the ‘Plain Language Information Statement’ (Healthcare Practitioner version).

 

 

 

If you have any questions or would like further information regarding the project titled ‘A randomised evaluation trial of the LIFE FLeX digital health and wellbeing program for depression and anxiety’, 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: b.klein@federation.edu.au        

 

 

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: research.ethics@federation.edu.au

CRICOS Provider Number 00103D