Plain Language Information Statement
Plain Language Information Statement
|An open trial evaluation of the BDZ (information and reduction) digital health program for people using benzodiazepines.|
|Professor Britt Klein: DVC-R Portfolio|
Other / Student Reseachers:
|Janet Shaw Manager, Reconnexion; A/Prof Peter Schattner Department of General Practice, Monash University); 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 this study. We invite people who are aged 18 years and over, who have access to the internet and telephone and who are thinking about or who want to reduce their benzodiazepine intake gradually, to participate in this BDZ digital health study.
In addition, participants must be living in Australia, not have a untreated psychotic mental illness, and agree not to use the ‘cold turkey’ method (that is stop taking their benzodiazepine medication all at once) should they wish to reduce their benzodiazepines while participating in the study.
What is the project about?
This project seeks to determine the efficacy of the BDZ digital health program and the factors that predict peoples’ use of the BDZ program. BDZ digital health is a 5 week online program designed to inform people about benzodiazepines, its dependency, and safe ways to reduce use. It also provides useful strategies to help people when they experience withdrawal effects from gradually reducing their benzodiazepine use.
The results from this project will be used by Federation University and Reconnexion researchers in the development of future BDZ 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 BDZ digital health.
Participants will be asked to:
- Create a ‘My Digital Health’ platform (the BDZ 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 BDZ program. Here you will need to agree to participate in the BDZ 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 questionnaire survey via this website. The questionnaire survey will ask you questions about yourself, including demographic details (e.g., age), your benzodiazepine use and dependency (e.g., current benzodiazepine dosage), and mental health and wellbeing (e.g., depressive, anxiety symptoms, strategies that you use to deal emotional and stressful situations, your quality of life, etc). The pre-program survey should take approximately 30 minutes to complete.
- Following this you will be given immediate access to the BDZ program. The BDZ digital health program consists of five core modules and an Introduction module; each module will require about 20 minutes. During this time we also strongly encourage you to use the Reconnexion benzodiazepine telephone support service, however it is entirely up to you if you do and if you disclose your participation in this study to the telephone support worker. Should you decide to commence reducing your benzodiazepine dosage, we strongly recommend that you involve your GP first.
- 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 BDZ digital health program to record your sleep, heart rate and number of steps per day.
- Complete two questionnaires at the start of Week 3. This should take 5 minutes to complete.
- Complete the post program questionnaires in Week 6, again asking you about your benzodiazepine use and mental health and wellbeing. This should take you about 25-30 minutes to complete.
- Complete the 3 and 6 month follow-up questionnaires at Week 18 and Week 30, which also asks you about your benzodiazepine use and mental health and wellbeing. These questionnaires should take you about 25-30 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 BDZ digital health 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 BDZ digital health program account, we will inform your healthcare practitioner (or you) of this.
The BDZ digital health program will record how many times you logged in, what modules and resources 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]).You will also be sent automated reminder emails/SMS’s during the 30 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 of the intervention and follow up time points, without having to provide any explanation. Your withdrawal will have no impact on current or future relationships with Federation University or Reconnexion.
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 (including email addresses) 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. 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?
The BDZ digital health program is a user friendly and interactive program that you should find enjoyable to use. This program will provide you with information and a better understanding about benzodiazepines and its reduction, as well as how to better manage reduction/withdrawal effects. Your input will also help us improve the program to help others who experience similar symptoms.
Are there any risks from participating?
No health risks are expected from participating in this project. However, as stressed throughout the BDZ program, we strongly discourage anyone for going ‘cold turkey’ (that is, stopping your medication completely, rather than reducing the dosage gradually) and we require you to agree not to use the ‘cold turkey’ method should you wish to stop taking benzodiazepines. We also strongly encourage you to speak with a Reconnexion benzodiazepine support worker to discuss the program and its contents whilst doing the program and that you involve your GP should you decide to reduce your benzodiazepine dosage.
You may feel 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 BDZ program, please contact a Reconnexion benzodiazepine specialist support worker on 1300 273 366, your 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 speeds, 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 trial evaluation of the BDZ (information and reduction) digital health program for people using benzodiazepines’, 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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