Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000928819
Ethics application status
Not yet submitted
Date submitted
30/07/2012
Date registered
31/08/2012
Date last updated
31/08/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A prospective, randomised, controlled trial of smoking cessation through personalised intervention
Scientific title
A prospective, randomised, controlled trial of smoking cessation through personalised intervention
Secondary ID [1] 280924 0
Nil known
Universal Trial Number (UTN)
U1111-1133-0502
Trial acronym
SCUPI 3 (Smoking Cessation through Personalised Intervention 3)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Smoking 287012 0
Condition category
Condition code
Public Health 287344 287344 0 0
Other public health
Mental Health 287618 287618 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Personalised video dramatising the potential consequences of having a heart attack secondary to smoking.
The video is personalised by inserting photos of the subject, non-smoking partner and family into the video. The video duration is 8 minute. It is viewed on 2 occasions separated by approximately one week, and is viewed by the participant alone, accompanied by a study investigator.
Intervention code [1] 285359 0
Treatment: Other
Intervention code [2] 285578 0
Prevention
Intervention code [3] 285579 0
Behaviour
Comparator / control treatment
The non-personalised video is the same as the personalised video except that the primary characters in the video are actors ie not the participant or family members.
Control group
Active

Outcomes
Primary outcome [1] 287614 0
Smoking Cessation Rate. The outcome is assessed by carbon monoxide breath test, and subject self-report.
Timepoint [1] 287614 0
Primary timepoint: 6 months
Secondary timepoints: 2 weeks, 3 months, 12 months
Secondary outcome [1] 298531 0
Psychological impact of the personalised video. We will evaluate psychological impact using a Video Response Scale (7 point Likert scale) we have developed for this proposal, and will also assess subjective distress response to the video using the Impact of Event Scale (IES) (Horowitz et al.1979).
Timepoint [1] 298531 0
1 week
Secondary outcome [2] 298532 0
Urge to smoke. This will be measured by the Questionnaire on Smoking Urges (QSU ? Brief Version) (Tiffany et al., 1991).
Timepoint [2] 298532 0
1 week
Secondary outcome [3] 298533 0
Awareness of the negative consequences of smoking. This will be assessed on a number of dimensions including health risks and as measured by the Risk Perception Scale (adapted from Borelli et. al., 2010).
Timepoint [3] 298533 0
1 week

Eligibility
Key inclusion criteria
Smoking subject with non-smoking spouse/partner willing to attend enrolment session (for having pictures taken)
Minimum age
30 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Psychotic disorder, Substance Dependence (including alcohol), Pregnancy. Screening for psychotic and substance disorders will be conducted with the use of the MINI Neuropsychiatric Inventory.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Prospective subjects and partners will receive an information sheet and consent form. They will then be seen by study investigators and eligibility confirmed. Once they have signed consent, treatment allocation will occur through contacting a central blinded person. Randomisation will be used with a randomisation table created by computer software, with stratification for study centre.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence will be generated by randomisation computer software, with stratification for study centre.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285707 0
Charities/Societies/Foundations
Name [1] 285707 0
North Shore Heart Research Foundation
Country [1] 285707 0
Australia
Primary sponsor type
Hospital
Name
Royal North Shore Hospital
Address
Reserve Road, St Leonards NSW 2065
Country
Australia
Secondary sponsor category [1] 284538 0
None
Name [1] 284538 0
Address [1] 284538 0
Country [1] 284538 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 287714 0
The Northern Sydney Local Health District (NSLHD) Human Research Ethics Committee
Ethics committee address [1] 287714 0
Research Business Unit
Level 13, Kolling Building Royal North Shore Hospital St Leonards NSW 2065
Ethics committee country [1] 287714 0
Australia
Date submitted for ethics approval [1] 287714 0
25/06/2012
Approval date [1] 287714 0
Ethics approval number [1] 287714 0
1206-179M

Summary
Brief summary
Smoking remains a major preventable risk factor for cardiovascular disease. This research proposal builds on 2 observations; firstly, experiencing a heart attack is a teachable moment that enables up to 60% smokers to abruptly quit once they have experienced a heart attack; and secondly, we have demonstrated in a pilot study that it is feasible to induce smoking cessation through subjects watching a DVD containing images of him/herself, his/her partner and family digitally superimposed into a scenario depicting the person having a heart attack as a result of smoking, and the potential consequences to the partner and family. Using this novel approach, which we describe as a personalized simulated teachable moment, 7 of 13 smokers (53%) were abstinent at 6 months (published in Am J Cardiol 2010). We have since completed 20 subjects of whom 12 (60%) were abstinent at 12 months.

In the current proposal, we will evaluate the simulated teachable moment hypothesis in a prospective randomized controlled study. We will compare smoking cessation rates using the personalized DVD with the same video using actors. In addition, we will evaluate the psychological impact of the personalized video. If this study demonstrates an additive effect of the personalized simulated teachable moment in smoking cessation, its use would be supported as an adjunct to smoking cessation, which in turn would have major health benefits in our society. We will conduct the study in selected General Practices and Pharmacies to investigate its broad applicability and ability to be disseminated widely.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34495 0
Address 34495 0
Country 34495 0
Phone 34495 0
Fax 34495 0
Email 34495 0
Contact person for public queries
Name 17742 0
Professor Geoffrey Tofler
Address 17742 0
Cardiology Department
Royal North Shore Hospital
St Leonards, NSW 2065
Country 17742 0
Australia
Phone 17742 0
61-2-99268688
Fax 17742 0
61-2-99067807
Email 17742 0
[email protected]
Contact person for scientific queries
Name 8670 0
Professor Geoffrey Tofler
Address 8670 0
Cardiology Department
Royal North Shore Hospital
St Leonards, NSW 2065
Country 8670 0
Australia
Phone 8670 0
61-2-99268688
Fax 8670 0
61-2-99067807
Email 8670 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.