Plain Language Information Statement
Plain Language Information Statement
CompassionateUs: A randomised evaluation trial of an interactive compassionate-based digital health program.
Professor Britt Klein: DVC-R&I Portfolio (Federation University)
Dr Lynne Reeder: School of Health & Life Sciences (Federation University); Asher Leslie: DVC-R&I Portfolio (Federation University)
Thank-you for your interest in this study. We invite people who are aged 18 years and over, who have access to the internet to participate in this CompassionateUs digital health study.
What is the project about?
This project seeks to determine the efficacy of the CompassionateUs digital health program and the factors that predict people’s use of it. CompassionateUs is an eight-week self-help web and mobile program designed to help people increase compassion for themselves and others, and increase wellbeing.
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.
What does this project involve?
The project involves collecting various pieces of information from you and about your usage of the CompassionateUs program.
Participants will be asked to:
- Create a ‘My Digital Health’ platform (the CompassionateUs 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 CompassionateUs program. Here you will need to agree to participate in the CompassionateUs study after reading through this Plain Language Information Statement and by clicking the “I agree to the above conditions” below.
- Complete the pre-program questionnaire survey via this website. The questionnaire survey will ask you questions about yourself, including demographic details (e.g., age) and your mental health and wellbeing (e.g., compassion levels, depressive and anxiety symptoms, strategies that you use to deal emotional and stressful situations). The pre-program survey should take approximately 30 minutes to complete.
- Consent to be randomly allocated to one of 3 versions of CompassionateUs
- The material covered in all 3 versions is identical, consisting of five compassion knowledge building modules and five compassion skill building modules. Each module should take 10-20 minutes to read. The compassion-skill building modules include practise activities, which would require about 10 minutes per day. The three versions only differ in terms of when the modules are made accessible.
- Complete a daily mood and lifestyle web or mobile survey (e.g., average daily optimism 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 CompassionateUs program to record your sleep, heart rate, and number of steps per day.
- Complete three questionnaires in Week 3 and 6 taking about 5 minutes to complete.
- Complete the post program questionnaires in Week 9, again asking you about your mental health and wellbeing. This should take you about 30 minutes to complete.
- You may also be invited by email (through the My Digital Health internal email system) to participate in a 15-minute telephone or video-chat discussion, with a member of our research team, asking you about your impressions and experiences of using the CompassionateUs program. This interview can take place via the telephone, digital chat (audio or visual), or instant messaging.
- Complete the 3-month follow-up questionnaire at Week 21, which also asks 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 CompassionateUs 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 CompassionateUs program account, we will inform your healthcare practitioner (or you) of this.
The CompassionateUs digital health program will record how many times you logged in, what modules you accessed, the amount of time you spend 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/SMS’s during your 21 weeks while being involved in this study. You will be asked to complete a brief online questionnaire about your engagement levels with the program.
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, without having to provide any explanation. All data provided by you up to that point however will not be destroyed or deleted from the database. 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 such as being re-analysed or added to other digital health data 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). 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 will use de-identified data only. 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 CompassionateUs digital health program is a user friendly and interactive program that you should find easy to use. This program will provide you with knowledge and skills around improving compassion levels. Your input will also help us improve the program to help others into the future.
Are there any risks from participating?
No health risks are expected from participating in this project, however you might 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 CompassionateUs digital health 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 ‘CompassionateUs: A randomised evaluation trial of an interactive compassionate-based digital health program’, or a summary of the results once the study is completed, please contact the Principal Researcher, Professor Britt Klein of the DVC-R&I 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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