Title

Smoking Cessation throUgh Personal Identification (SCUPI)

Name of Chief Investigator

Professor Geoffrey Tofler 

Sponsors

Funding support through a grant from the SPARK program (Kolling Institute, Royal North Shore Hospital, Sydney, and University of Technology, Sydney) and Heart Research Australia.

What is the purpose of the study?

The purpose is to investigate the effectiveness of a new video-based technique to help people stop smoking tobacco. In earlier published work using a similar technique, we achieved a high result of smoking cessation, with 54% quit rate measured at 6 months. Previous work was conducted face-to-face; however to allow greater access and flexibility, we are now able to invite participants to attend via videoconferencing online.

This study has been approved by the Northern Sydney Health Human Research Ethics Committee (NSLHD reference 1206-179M, HREC/12/HAWKE/172).


Where will this study be conducted?

You will participate via your internet connection from your own location in Australia, and the study will be overseen by researchers at Royal North Shore Hospital.


What will happen if I take part in the study?

Screening
Firstly, you will need to complete a brief screening form on the study website to determine whether you are eligible to participate.
You will be asked questions about your smoking history, and your physical and psychological wellbeing. A member of the research team will then contact you to explain the study in more detail, check that you have the appropriate network, videoconference and camera capability, and answer any questions. You will then be asked to agree to consent for the study.

Participant's partner
To be in the study, you will need to have a non-smoking partner, or significant other who agrees to participate. Their role will be to have a digital photograph taken of them for the video, and to act as a proxy at 3 and 6 months to confirm your smoking status. We will contact your partner at 3 and 6 months to confirm if you are smoking or abstinent. You will need to discuss this with your partner, and upon their consent supply us with their email address so that we may contact them for confirmation of participation.
Participant's proxy
If your partner is not able to act as proxy to confirm your smoking status (usually because you are not living in the same location) then you will need to appoint someone else to confirm your smoking status. You will also need to discuss consent with this person, and if they agree to participate you will need to supply us with their email address. We will then confirm their consent via email.
Photos
Digital photos will need to be taken of you and your partner at different angles.), We will also need one photo of your loved ones (e.g. a family photo). These images will be used in a treatment video for your viewing and will not be shared with any other person.
Please refer to instructions on how to take photographs for our requirements.

Images can be uploaded to https://jumpshare.com/i/iscupi or sent by email to nslhd-quitnow@health.nsw.gov.au


Treatment

Treatment will involve four sessions via a video-conference call using ‘Pexip’ You will need to install Pexip before session one of the program. Please see How To Install Pexip for assistance.


How the study works:

During the study you will also be contacted by telephone and SMS messaging to assist you in quitting.

We do recommend that you use nicotine replacement therapy (NRT) to help in the process of quitting.. NRT products will not be provided by the study team, but the appropriate treatment will be discussed with the study counsellor.

Session 1 will involve a videoconference call with a member of the research team (the counsellor). During this call, you will watch a short 8-minute video streamed to your electronic device (computer/tablet/iPad), with a brief interview with the counsellor before and after the screening. You will also be asked to complete two short questionnaires, and your quit-smoking plan will be discussed.

The documentary style video will include three scenes with you as the main character, and your loved ones transposed on to other characters’ of the story. The video shows that a heart attack is a potential consequence of continuing to smoke, and provides a visual representation as if you were the person having the heart attack.

After the video you will have the opportunity to talk to the counsellor about this experience. The main goal of this screening is for you to graphically visualise a potential consequence of continued smoking. This builds on observations that approximately 60% of smokers stop smoking when they have experienced the threat of a heart attack.

Session 2 will occur about one week after session one and will include a rescreening of the video and further counselling to help you in the quitting process.

Sessions 3 and 4 will occur at three and six months after session one took place. These sessions will also take the form of a videoconference call, and you will be asked about your progress, and given ongoing encouragement and advice on how to remain abstinent/quit smoking.

After sessions three and four your partner or proxy will be contacted by phone or email to confirm your smoking status. Please refer to participant's partner and participant's proxy, in this section.

In session three you may be shown the video for the third time at the study investigator's discretion, or if you request to see it again.

If you are not smoking or using nicotine replacement therapy (NRT) at your third or fourth session you will also be asked to provide a small sample of saliva to biologically confirm your smoking status. You will be supplied with testing kits via post for this purpose and the counsellor will guide you through the test process. Results will be determined during the videoconference.
 


What are the risks or side effects of taking part in this study?

There are no known risks attached to the study.

Some people may experience short-term emotional discomfort in reaction to the video. If this occurs, you will be able to discuss this with the counsellor during the session or by telephone afterwards.

There are a range of possible withdrawal symptoms that people experience when stopping smoking. Some people will experience one or two symptoms, but this will occur mainly within the first 2-3 days after quitting. Your previous quitting attempts may give you an idea of what to expect in this regard.
The study will be conducted according to good clinical practice guidelines, and has received approval from Northern Sydney Health Human Research Ethics Committee.  


What are the possible benefits of taking part?

You will find advantageous benefit in an intensive, supportive quitting program; and ultimately the long term health benefits of permanently quitting.
The study aims to shed new light on quit smoking techniques, particularly when using the internet as the primary medium. Your participation benefits researchers in obtaining this information.


What are the alternatives for treatment?

The investigators will be happy to refer you to other smoking cessation services or clinics where available.


What if I decide to withdraw from the study?

Your participation in this study is entirely voluntary. You are free to withdraw consent at any time during the study without any effect on your care. 


Will my taking part be confidential?  How will the information be used?

Information that is collected through this study will be coded to maintain confidentiality.
Research staff will collect and maintain your personal and medical information which will be stored in password protected Google Docs. You will be identified with an individual study number and any other identifiable information that is collected will remain confidential.
It is important to know that whilst our best efforts are made to protect the information that you provide us, the study does involve the transfer of identifiable health information over the internet. Please read the privacy policy for Google Docs at https://www.google.com/policies/.
Video-conferencing will be carried out using the Pexip Application which you will need to install. We will help you with that as needed. Please read the Pexip privacy policy at https://www.pexip.com/privacy. Uploading of the photographs will occur using Jumpshare. Please read the Jumpshare privacy policy at https://jumpshare.com/privacy
In participating, you agree that your health and other personal information can be collected, processed, transferred and stored for research purposes according to regulatory requirements, and if required, shared with national research regulatory agencies. This information, including digital photos and video sequences that incorporate images of you and your partner will be stored for seven years and then destroyed.
If the results of the study are published, the identity of you, your partner or proxy will not be revealed. No individual information will be described in any publications. A copy of final results and publications will be made available to you.


Will it cost me money to participate? Will I be compensated for participating? 

There is no direct charge to you to participate, however please keep in mind that expenses related to internet or mobile phone use incurred during this study are at your own cost and cannot be reimbursed. Any medication you choose, such as NRT patches and lozenges, is also at your own cost. On completion of the study you will be reimbursed with a $40 gift voucher.  


What if something goes wrong?

If you suffer any injuries or complications as a result of this study, you should contact the study investigator as soon as possible, who will assist you in arranging appropriate medical treatment. You may have a right to take legal action to obtain compensation for any injuries or complications resulting from the study, if your injury or complication is caused by the drugs or procedures or by the negligence of any of the parties involved in the study. If you receive compensation that includes an amount for medical expenses, you will be required to pay for your medical treatment from those compensation monies. You do not give up any legal rights to compensation by participating in this study. If you are not eligible for compensation for your injury or complication under the law, but are eligible for Medicare, then you can receive any medical treatment required for your injury or complication free of charge as a public patient in any Australian public hospital. 

If you have any concerns about the conduct of this study or your rights as a participant, please contact the Research Office based at the Royal North Shore Hospital and quote the following reference number:

NSLHD 1206-179M, HREC/12/HAWKE/172.

NSLHD Research Office

Research Governance and Compliance Manager

Telephone: 02 99264590

Email: NSLHD-Research@health.nsw.gov.au


Other Information:

You may cease participation at any time and for any reason, or decline to participate in any part of the study.
You will receive a copy of this information sheet by email at the time of your consent. Remember to keep a copy of your reply consent email.
If you would like to discuss our program further, please contact us.

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