Participant Information Sheet/Consent Form
Title | Feasibility, acceptability, and real-world effectiveness of a Drink Tracker for alcohol behaviour change. |
Short Title | Daybreak Drink Tracker Research Study |
Principal Investigator | Mrs Dominique-Robert Hendren – Hello Sunday Morning, Sydney, Australia |
Co-Investigator | Dr Kathryn Fletcher – Hello Sunday Morning, Sydney, Australia |
Part 1 What does my participation involve?
1. Introduction
You are invited to take part in this research project, aiming to help us understand the real-world impact of the Daybreak Drink Tracker for alcohol behaviour change. This Participant Information Sheet/Consent Form tells you about the research project. Knowing what is involved will help you decide if you want to participate, so please read this information carefully. Before deciding whether to take part, you might want to talk about it with a relative, friend or your local doctor. Take as much time as you need to decide if you would like to participate. If you have any questions about anything that you don’t understand or want to know more about, please feel free to email the research team.
If you decide you want to take part in the research project, you will be asked for your consent by clicking “I agree”. By clicking this you are telling us that you:
- Understand what you have read
- Consent to take part in the research project
- Consent to the use of your information as described.
2. What is the purpose of this research?
Hello Sunday Morning’s (HSM) mission is to help people change their relationship with alcohol. We offer digital health products and services that everyone can access. The aim of this study is to understand how our new feature within Daybreak – the Drink Tracker – may help people change their relationship with alcohol. We are interested in your experience of the Drink Tracker and how this influences your engagement with Daybreak, as well as any impact this may have on your alcohol consumption and psychological wellbeing.
3. What does participation in this research involve?
If you consent to participate, you will be participating in a research project that will continue for 3 months. After registering for Daybreak, you will have access to the Drink Tracker, which you can use as often as you like. If you decide that you do not want to participate, you will still have access to the Drink Tracker. Your data (registration information, Daybreak usage data) will be used for this research to help us understand your experience of the Drink Tracker and its impact as a feature of Daybreak.
If you agree to participate in this research, you will be also asked to complete the following online questionnaires:
When is this completed? | How long will this take? | |
Monthly check-in questionnaire | Month 1, 3 | 5-mins each |
Feedback questionnaire | Month 3 | 10-mins |
Criteria for participation. To participate in the research, you must be 18 years or older and have registered for Daybreak.
4. Do I have to take part in this research project?
Participation in any research project is voluntary. If you do not wish to take part, you do not have to. If you decide to take part and later change your mind, you are free to withdraw from the project at any stage. Your decision whether to take part or not to take part, or to take part and then withdraw, will not affect your routine care, your relationship with professional staff or investigators on the project or your relationship with HSM or partnering organisations. If you decide to withdraw your participation, your data will be retained and used unless you explicitly request for your data to be deleted.
5. What are the possible benefits of taking part?
We cannot guarantee that you will receive any benefits from this research. However, you will be assisting in the ongoing development of HSM products and services that we hope are useful to people seeking to change their relationship with alcohol.
6. What are the possible risks and disadvantages of taking part?
Discomfort or distress
If you agree to participate in this research, you will be asked questions about your alcohol consumption and psychological wellbeing. In general, it is not anticipated that this would give rise to any negative effects. If you do feel distressed when answering these questions, please let the research team know or consider contacting the services provided below. If you feel uncomfortable with any aspect of your participation, you are free to discontinue your participation at any time.
This program does not replace your usual medical care.Because this is an international study, we are not able to take on the responsibility for your health care or wellbeing. There is no emergency assistance available through the Daybreak app, which is not monitored across all the time zones that participants are coming from.
If you experience or believe you are at risk of self-harm, you should seek immediate assistance from your medical practitioner or emergency department. If you are located in Australia and need support, please contact:
- Counselling Online: a free and confidential service that provides 24/7 online support https://www.counsellingonline.org.au/how-we-can-help/chat-to-a-counsellor
- Alcohol and Drug Information Service (ADIS): a free and confidential phone service available 24/7 to provide information, referrals, and counselling support. Call 1800 250 015
- NSW Get Healthy Coaching Service: is a free telephone based coaching service for NSW residents. The service is available Monday to Friday (8am-8pm).
https://www.gethealthynsw.com.au/ (Call 1300 806 258) - For 24/7 support you can also call Lifeline on 13 11 14.
- Please call 000 in the event of an emergency
If you are based overseas and need support, please contact:
- Find a helpline: free and confidential support from a helpline or hotline near you (online, chat or text) https://findahelpline.com/i/iasp
- International Suicide Prevention Hotlines: http://www.suicide.org/international-suicide-hotlines.html
- Please call the International Emergency Number (112) in the event of an emergency
Compensation for injury
If, as a result of your participation in this study, you become ill or are injured, advise the clinical contact (Dominique Robert-Hendren, see p 5) for this study. In the first instance the clinical contact will evaluate your condition and then discuss appropriate resources and support services with you. Any question about compensation must initially be directed to the clinical contact, who should advise their insurer of the matter. You may be able to seek compensation through the courts. It is the recommendation of the independent ethics committee responsible for the review of this study that you seek independent legal advice.
7. What if I withdraw from this research project?
If you do consent to participate, you may withdraw at any time. If you decide to withdraw from the project, please email our research team (research@hellosundaymorning.org).
If you decide to leave the research project, we will not collect additional information from you, although information already collected will be retained to ensure that the results of the research project can be measured properly and to comply with law. You should be aware that data collected up to the time you withdraw will form part of the research project results. If you do not want your data to be included, you must tell the researchers when you withdraw from the research project. Requests for removal of data must be received prior to the end of the study (October 2025).
8. What happens when the research project ends?
We expect to publish the results of this study when it is completed (October 2025). Scientific findings will be published in scientific journals, presented at conferences, and disseminated via the HSM website. Participants will also be emailed a summary of the study findings. In all types of publication, only group data will be presented and no individuals will be identified.
Part 2 How is the research project being conducted?
9. What will happen to information about me?
Confidentiality. Any information obtained in connection with this research project that can identify you will remain confidential. It will only be disclosed with your permission, except as required by law. All participants will be identified by a code number. Only the researchers involved in the study will have access to the information.
Disclosure of information to people outside the organisation. As outlined in the Daybreak Privacy Policy (https://hellosundaymorning.org/privacy-policy), we do not sell your information to third parties. To the extent practicable HSM will only disclose de-identified information about members outside its organisation on the following bases:
a)to HSM’s accountants, funders, grant providers, financial advisors and legal advisors for the purposes of maintaining the provision of the Daybreak’s services and HSM’s business generally;
b)to HSM’s academic partners and/or academic publications for the purposes of publishing research regarding the usage and effectiveness of Daybreak in helping members change their relationship with alcohol;
c) to HSM’s service providers and contractors to help HSM provide, manage, administer, monitor, distribute, operate or facilitate Daybreak’s services; to develop, market or provide HSM’s products and services, and to enable HSM to provide and improve its services (for example, web hosting companies, website administrators, mobile app distribution platforms, support services companies, marketing campaign attribution services, data analytics and analysis companies, advertising partners and payment processing venders);
d)to law enforcement, government or regulatory bodies, lawful authorities, or other authorised third parties: in order to comply with laws, regulations, court orders, or other legal obligations, assist in an investigation, protect and defend our rights and property or the rights or safety of third parties, to enforce our terms of use, privacy policy, or agreements with third parties, or to assist with crime-prevention purposes; or
e)to any other third parties:
- if HSM considers it necessary to protect the rights or property of HSM or any other individual, or to lessen a serious threat to a person’s health or safety;
- if a member has given permission for us to do so;
- to obtain funding or prospective funding for HSM to perform its services;
- to configure the Daybreak’s services to meet members or a member’s wishes and needs;
- to generate anonymous statistical data;
- where there is a change of control in HSM’s business or a sale or transfer of HSM’s business assets, HSM reserves the right to transfer to the extent permissible at law, Daybreak, together with any Personal information (including Sensitive and Health Information) and de-identified information of MEMBERS, to a potential purchaser of HSM’s assets on the condition that they maintain the information confidentially and in accordance with this Privacy Policy.
Participants should note that, some data from your participation in this study will be sent overseas or shared with persons outside Australia. The regulatory regimes governing data access and use in other countries may not be the same as those that are in place in Australia. In the case of data that identifies you, or from which your identity may be ascertained, a person or organisation subject to Australian privacy laws that has collected your information must take reasonable steps to ensure that an overseas recipient handles the information in accordance with any relevant Australian privacy principle (unless an exemption applies). If you have any questions about this, direct them to the Principal Investigator.
Security. Following Australian Health Data regulations and requirements of the overseeing ethics committee, all data will be securely held by Hello Sunday Morning for 15 years following completion of the study. Whilst we endeavour to ensure that personal information is secure, it is not possible to safeguard against all possible breaches of security. Participants are advised to ensure that the device from which they participate is secure and to log out of the device after they have finished a session on it. As outlined in the Daybreak Privacy Policy (https://hellosundaymorning.org/daybreak-privacy-policy), Daybreak security includes the encryption of all data during transmission using Transport Layer Security (TLS) encryption for all transmitted data between the client applications and the back-end services. All databases are set up with Amazon’s Key Management Service (KMS) for encryption of data at rest. All data are maintained on secure services for a period of time, as defined by relevant laws. Some data is stored and processed on servers located in Australia and some is stored and processed in the United States of America. Access to stored data is protected by multi-layer security controls including firewalls, role-based access controls and passwords.
Publications. In any publication, information will be provided on a group level such that no individual can be identified.
Accessing information about you. In accordance with relevant Australian privacy and other relevant laws, you have the right to access the information collected and stored by the researchers about you. Please email our privacy officer if you would like to access your information. For further information, please see our privacy policy (https://hellosundaymorning.org/privacy-policy)
10 Who is organising and funding the research?
Funding. This research has been funded by the nib foundation (an Australian health care fund)
Co-ordination. It is being co-ordinated by Hello Sunday Morning in Sydney, Australia.
Commercialisation. Although not planned at this time, it is possible that in the future Hello Sunday Morning may seek to commercialise intellectual property arising from this research. You will not benefit financially from your involvement in this research project even if, for example, knowledge acquired from your participation proved to be of commercial value. In addition, if knowledge acquired through this research leads to discoveries that are of commercial value to Hello Sunday Morning or the nib foundation, there will be no financial benefit to you or your family from these discoveries. No member of the research team will receive a personal financial benefit from your involvement in this research project (other than ordinary wages).
11 Who has reviewed the research project?
All research in Australia involving humans is reviewed by an independent group of people called a Human Research Ethics Committee (HREC). The Bellberry HREC (https://bellberry.com.au/) has reviewed and approved this study in accordance with the National Statement on Ethical Conduct in Human Research (2007) – incorporating all updates. This Statement has been developed to protect the interests of people who agree to participate in human research studies. Should you wish to discuss the study or view a copy of the Complaint procedure with someone not directly involved, particularly in relation to matters concerning policies, information or complaints about the conduct of the study or your rights as a participant, you may contact the Operations Manager, Bellberry Limited on (08) 8361 3222.
12 Further information and who to contact
The person you may need to contact will depend on the nature of your query. If you want any further information concerning this project or if you have any problems which may be related to your involvement in the project, you can contact the following people:
Name | Dominique Robert-Hendren |
Position | Chief Digital Health Strategy Officer, Hello Sunday Morning |
dominique.roberthendren@hellosundaymorning.org |
Name | Kathryn Fletcher |
Position | Digital Mental Health Research Lead, Hello Sunday Morning |
research@hellosundaymorning.org |
Name | Shefali Shah |
Position | Digital Mental Health Project Officer, Hello Sunday Morning |
privacy@hellosundaymorning.org |
Declaration by Participant
- I have read the project information above and I understand the purposes, procedures and risks of the research described in the project.
- I have had an opportunity to ask questions and I am satisfied with the answers I have received.
- I freely agree to participate in this research project as described and understand that I am free to withdraw at any time during the project without affecting my future relationship with Hello Sunday Morning or partnering organisations.
- I am over 18 years of age.
By clicking “I agree” I am acknowledging the above and agree to participate in the study.