Information page

Secure and safe

The SCUPI study treats the collection, gathering and storage of Information in a secure manner at all times.

The SCUPI Team has compiled a list of important information about the study, participant consent, information access and your on-going support below.

Participant information & Consent

Northern Sydney Local Health District Participant Information Sheet

Name of the research study: Smoking Cessation through Personal Identification (SCUPI)

Name of Coordinating Principal Investigator: Professor Geoffrey Tofler 

Sponsors:  Internal funding (Professor Geoffrey Tofler)

Introduction

Despite the available quit smoking techniques, it is often difficult for smokers to quit.  Our novel approach uses the observation that six out of 10 smokers quit immediately after having the "teachable moment" of a heart attack.  In our prior studies, including over the internet, we have shown that it is possible to help more than half of the smokers to quit by a program that includes watching a personalised video that contains images of the smoker, their partner and family, digitally inserted into a scenario of a heart attack caused by smoking.

What is the purpose of the study?

To further evaluate the effectiveness of our video-based technique, conducted over the internet, to help people stop smoking tobacco. 

Where will this study be conducted?

It will be conducted from Royal North Shore Hospital and you will participate via your internet connection from your own location in Australia.

What will happen with participants who join in the study?

1. Screening

Firstly, you will need to complete this screening form to determine whether you are eligible to participate.

You will be asked questions about your smoking history, and your physical and psychological well-being. A member of the team will then contact you to explain the study in more detail, answer any questions, and arrange for your first videoconference session.

2. Consent

In the next section you will then be asked to agree to consent for participating in the study.

Participant's (your) partner

To be in the study, you will need to have a partner, or 'significant other' who, if they are a non-smoker, agrees to participate to confirm your smoking status at 3 and 6 months. If they are a non-smoker their role will also be to have a digital photograph taken of them for the video. We will contact your partner at 3 and 6 months to confirm if you are smoking or abstinent. Once you have spoken to your partner, you will need to supply us with your partner's private (i.e. confidential) email address, so we can send an email to get confirmation of their consent.

Participant's proxy

Note that if your partner is not able to confirm your smoking status (usually because you are not living in the same location) then you will need to appoint someone else, a 'proxy', to confirm your smoking status. Your proxy will also be asked to agree to participate. Therefore, in this instance you will need to supply us with the proxy's private email address as well so that we can obtain consent from them via email.

3. Other information about the study

You will need to supply us with digital photos of you and your partner from different angles (instructions for photographs are provided on the website). 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 only and will not be shared with any other person.

Instructions will be provided on the website for these images to be sent to us.

Test videoconference/information session

This is a videoconference call with a member of the team (the counsellor). During this call, the counsellor will test the effectiveness of the videoconference facility, usually depending on your internet bandwidth or capacity.

We recommend that you use nicotine replacement therapy (NRT) to help you quit, commencing 2 weeks before Session 1.

The counsellor will explain the reasons for this, as well as other appropriate treatment. NRT products will not be provided by SCUPI, but your doctor can provide prescriptions to reduce the cost substantially.

Treatment  

This will involve four treatment sessions via a video-conference call using 'Pexip', which is a program similar to Skype. You will not need to install any apps for this.

Session 1

This is a videoconference call with the counsellor. During this call, you will watch a personalised 8-minute video streamed to your electronic device (computer/tablet/phone), 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, including a quitting date.

In the personalised video you will view three scenes, with you as the main character. The images of your 'family photo', yourself, and your partner if they are a non-smoker, will be transposed on to the characters in the story. The video, which is in the style of a short documentary, 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.

You will have time afterwards to talk to the counsellor about this experience and be asked to comment. The main goal of this screening is for you to graphically visualize potential consequences, of continued smoking, for both you and your loved ones. This builds on observations that approximately 60% of confirmed smokers stop smoking when they have experienced the threat of a heart attack.

Session 2

This will occur about one week after Session 1 and will include a rescreening of the personalised video and counselling to help you in the quitting process.

Sessions 3 and 4

These will occur at 3 and 6 months respectively, following Session 1. 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 from smoking.

After sessions 3 and 4 your partner or proxy will be contacted by email to confirm your smoking status. Please refer to Participant's partner and Participant's proxy, in this section (above).

In session 3 (at 3 months follow-up), you may be shown the video for the third time at the counsellor's discretion, or if you choose to see it again.

In Session 4 (at 6 months follow-up), if you are not smoking or using nicotine replacement therapy (NRT), you will also be asked to provide a small sample of saliva to biologically confirm your smoking status. For this purpose you will be supplied with testing kits via post. The counsellor will guide you through the test process and the results will be determined during the videoconference. 

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

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 is 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, and the use of NRT will alleviate these to a good degree.

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 benefit if your participation helps you stop smoking and stay stopped. Your participation in the study may also provide new information for health professionals about ways to make quit smoking studies more effective and more widely available, especially when using the internet as the primary medium.

What are the alternatives for treatment?

The investigators can 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?

Confidentiality will be protected replacing your identifying details with a code number.

Study staff will collect some personal and medical information for the study using password protected Google Docs and Google Drive. You will be identified with an individual study number and any identifiable information that is collected about you 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.  The details are set out in the Google Docs privacy policy at https://www.google.com/policies/  

Videoconferencing will be carried out using the Pexip platform which is highly secure and approved by NSW Health. The details are set out in the Pexip privacy policy at https://www.pexip.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 stored for 7 years and then deleted. If the results of the study are published, the identity of you, your partner, and "proxy" will not be revealed. No individual information will be described in any publications.

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

There is no charge to you for the study or expenses involved in providing the service other than the costs for internet and (where relevant) mobile phone services.

You will not receive any money for taking part in the study. Any medication you use, such as nicotine replacement therapy (NRT), will need to be purchased and funded by yourself.

What if something goes wrong?

If you suffer any complications as a result of this study, you should contact us as soon as possible, and we will assist you in arranging appropriate medical treatment.

You do not give up any legal rights to compensation by participating in this study. 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. 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:

2019/ETH08416.

NSLHD Research Office

Research Ethics Manager

Telephone: 02 99264590

Email: [email protected]


Other Information:

You may stop your participation at any time and for any reason, or decline to participate in any part of the study.

If you would like to discuss our study further, please contact us.

SCUPI contact information:

Email: [email protected]

If you have specific enquiries, please contact Mr Robin May on the details below:

Phone: +61 (02) 9463 2517 or

Email: [email protected]

 

Consent Form

Please note: The section below is for information purposes only. It is a copy of the form which is completed online as part of the enrolment process

Name of research study: Smoking Cessation through Personal Identification 

Thank you for agreeing to participate in our study.

Following a discussion with one of the research investigators you have been invited to participate in a research project entitled "Smoking Cessation through Personal Identification (Internet version)", abbreviated as "SCUPI"

Principal Investigator: Professor Geoffrey Tofler

Before consenting to participate in our study, it is important to read the Participant Information in the section above.

To give your consent as a participant in this study, complete the following steps:

1. Read and agree with the following:

* I acknowledge that I have read the Participant Information, which explains the aims of the study and the nature of my role as the participant.

* I agree to participate in this study.

* I have the opportunity of asking any questions about my participation by telephoning Robin May, or a member of the team on (02) 9463 2517 or email [email protected], and we will respond.

* I understand that I can withdraw from the study at any time without prejudice to my relationship to the Royal North Shore Hospital, Sydney.

* I agree that research data gathered from the results of the study may be published, provided that I cannot be identified.

* I understand that if I have any concerns or complaints relating to this research, I may contact the Research Office based at the Royal North Shore Hospital on 02 9926 4590 during office hours (Eastern Standard Time) and quoting the following:

NSLHD reference 2019/ETH08416

A copy of this Consent Form can be accessed at any time on the SCUPI website (www.SCUPI.com.au)

2. Respond to the statement below ("I consent to participating in the study in accordance with the information provided above") by choosing one of the responses ("Yes", OR "No", OR "Before proceeding I wish to talk to a team member")

 

Kind regards,

Professor Geoffrey Tofler

The SCUPI Team

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