Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000596707
Ethics application status
Approved
Date submitted
24/05/2013
Date registered
27/05/2013
Date last updated
30/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Helping smokers to quit through increasing their appreciation of health risks information
Scientific title
Reducing the burden of lung disease: Using self-affirmation to reduce defensiveness towards health risk information among smokers with chronic obstructive pulmonary disease
Secondary ID [1] 282570 0
Nil
Universal Trial Number (UTN)
U1111-1143-5613
Trial acronym
SACO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic obstructive pulmonary disease 289244 0
tobacco smoking 289246 0
Condition category
Condition code
Respiratory 289573 289573 0 0
Chronic obstructive pulmonary disease
Mental Health 289581 289581 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Materials: The proposed study will be administered entirely via computer surveys and procedures, either using a study laptop or online for participants wishing to complete the study on a personal computer from home. Self-affirmation manipulation, threat message (smoking risk information), and survey questions will be compiled into a survey battery accessed via laptop or a secured web address. Participants will be asked to fill out the questionnaire once only (which includes self-affirmation task and warning message) and should take approximately 40 minutes.

Randomization: Participants will be randomised to either the self-affirmation or control condition. The study will utilise a cross-over design, where by at the conclusion of their participation, both control and treatment group participants would have been self-affirmed; the treatment group before health risk information, and control group after health risk information. After screening for eligibility, participants will be provided with the online survey website address, a unique subject identification number and unique password to access the study survey. This unique password will also randomly allocate the participant to one of the two conditions.

Self-affirmation manipulation: The present study will use the Classification of Character Strengths to manipulate self-affirmation in participants. This measure has been shown to reliably manipulate self-affirmation and is well suited to computer/online administered questionnaire forms. For the treatment group, self-affirmation manipulation will be presented prior to the threat message to ensure greatest effect. To check if self-affirmation manipulation has occurred, participants will be asked to rate their ‘overall feeling’ from ‘very bad’ to ‘very good’. By situating this question at the end of the questionnaire any theoretical possibility such a check could annul the self-affirmation effect will be avoided. Subjects in the control group will be asked to complete a time matched non-self-referent task before the health risk information where instead of rating themselves, they will be asked to rate a well-known personality on the same attributes. Control and treatment groups will conclude their respective questionnaire with the alternative forms of the Classification of Character Strengths (self-affirmation questionnaire).

Smoking risk information: Health risk information will be provided to participants in the form of a short government sponsored quit smoking/anti-smoking advertisement (for example; http://www.youtube.com/watch?v=sjrnaHInUHM). It is anticipated that a visual and auditory presentation of risk information will elicit a more threatening response than text or picture alone. Smoking risk information is presented to both groups, embedded approximately midway through the questionnaire.
Intervention code [1] 287233 0
Behaviour
Comparator / control treatment
Participants in the control group will not receive self-affirmation manipulation prior to being presented with the health risk information (will instead do a non self-referent task prior to health risk information; self affirmation task will be done after risk information/at conclusion of questionnaire) and it is anticipated that as a result they will be more defensive towards the presented health information, and less likely to intend to quit smoking.
Control group
Active

Outcomes
Primary outcome [1] 289668 0
It is hypothesised that participants in the treatment group (self-affirmed) will report a greater intention to quit smoking (“How certain are you that you will actually quit smoking in the future?” 1-Very certain - 7-Not at all certain) compared to participants in the control group who have not been affirmed.
Timepoint [1] 289668 0
Outcome measures will be measured as part of questionnaire.
Secondary outcome [1] 302979 0
It is hypothesised that participants in the treatment group (self-affirmed) will report higher message acceptance (as measured by “How important do you think it is that people stop smoking in order to avoid the problems mentioned in the video?” 1-Not important – 7-very important).
Timepoint [1] 302979 0
Outcome measures will be measured as part of questionnaire.
Secondary outcome [2] 302984 0
Participants in the treatment group are expected to report higher risk perception (“How likely do you think you will be to get cancer as a result of your smoking?” – 7-point scale – impossible [1] – extremely likely [7]) compared to participants in the control group who have not been affirmed.
Timepoint [2] 302984 0
Outcome measures will be measured as part of questionnaire.
Secondary outcome [3] 302985 0
Participants in the treatment group are anticipated to report higher self-efficacy (as measured by “If I wanted to, I could easily cut down the number of cigarettes I smoke in the next 7 days” 1-Totally agree – 7-totally disagree) compared to control group.
Timepoint [3] 302985 0
Outcome measures will be measured as part of questionnaire.

Eligibility
Key inclusion criteria
To be eligible to participate subjects must be current smokers with or without a diagnosis of chronic obstructive pulmonary disease with a minimum of 20 pack years, be aged 40 years and older and be referred for lung function testing.
Minimum age
40 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Younger than 40, less than 20 cigarette pack years.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Smokers will be recruited through the Northern Lung Function Service (NLFS) which provides respiratory diagnostic and monitoring services to the medical community in the North and North West of Tasmania. Participants will be 40 years and older, with a minimum smoking history of 20 pack years. The lung function results of patients of the NLFS will be used by NLFS staff to identify or confirm the presence of COPD. Staff of the NLFS will then provide eligible patients with a study information sheet, including researcher contact details. Patients can then choose to contact (phone or email) the researchers for further information about the study and/or enrol for participation. Upon contacting the researchers, potential participants will be provided with additional study information, have any questions answered, be screened for eligibility, and if eligible, enrolled in the study. After screening for eligibility, participants will be provided with the online survey website address, a unique subject identification number and unique password to access the study survey. This unique password will also randomly allocate the participant to one of the two conditions.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Subjects will be assigned to one of two conditions by electronic random number generation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The proposed study will adopt a crossover 2 by 2 between subjects design: (Group: COPD smokers vs. non COPD smokers) x (Condition: self-affirmation vs. control). Analysis of variance will be conducted to determine if there is an interaction between group and condition.

A previous, self-affirmation study into message acceptance of smoking information (Griffin & Harris, 2011) found a medium to large effect of d = .60 with a power of beta = .80. Based on the difference in message acceptance in that study, a 15% increase in acceptance with self-affirmation, and to obtain an interaction effect with 80% power to detect an effect 10% larger in affirmed smokers with COPD, we will require 90 participants completing the study. We will over-recruit by 15% to allow for an unequal ratio of participants with or without COPD and attrition, giving a target of N = 114 recruited participants.

[Griffin, D. W., & Harris, P. R. (2011). Calibrating the response to health warnings: Limiting both overreaction and underreaction with self-affirmation. Psychological Science, 22(5), 572-578. doi: 10.1177/0956797611405678]

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/02/2014
Actual
15/09/2014
Date of last participant enrolment
Anticipated
26/09/2014
Actual
31/12/2016
Date of last data collection
Anticipated
Actual
31/12/2016
Sample size
Target
114
Accrual to date
Final
110
Recruitment in Australia
Recruitment state(s)
TAS
Recruitment postcode(s) [1] 6916 0
7250 - Launceston

Funding & Sponsors
Funding source category [1] 287349 0
Charities/Societies/Foundations
Name [1] 287349 0
Clifford Craig Medical Research Trust
Country [1] 287349 0
Australia
Primary sponsor type
Individual
Name
Dr Mai Frandsen
Address
School of Pharmacy
C/O Locked Bag 1320
University of Tasmania
Launceston, Tasmania, 7250
Country
Australia
Secondary sponsor category [1] 286096 0
Individual
Name [1] 286096 0
Dr Julia Walters
Address [1] 286096 0
School of Medicine
Locked Bag 23
University of Tasmania
Hobart, Tasmania, 7000
Country [1] 286096 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289325 0
The Tasmania Health and Medical Human Research Ethics Committee
Ethics committee address [1] 289325 0
Ethics committee country [1] 289325 0
Australia
Date submitted for ethics approval [1] 289325 0
24/05/2013
Approval date [1] 289325 0
29/05/2013
Ethics approval number [1] 289325 0
H0013242

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40314 0
Dr Mai Frandsen
Address 40314 0
School of Pharmacy
C/O Locked Bag 1320
University of Tasmania
Launceston, Tasmania, 7250
Country 40314 0
Australia
Phone 40314 0
+61 3 6324 3137
Fax 40314 0
Email 40314 0
Mai.Frandsen@utas.edu.au
Contact person for public queries
Name 40315 0
Mai Frandsen
Address 40315 0
School of Pharmacy
C/O Locked Bag 1320
University of Tasmania
Launceston, Tasmania, 7250
Country 40315 0
Australia
Phone 40315 0
+61 3 6324 3137
Fax 40315 0
Email 40315 0
Mai.Frandsen@utas.edu.au
Contact person for scientific queries
Name 40316 0
Mai Frandsen
Address 40316 0
School of Pharmacy
C/O Locked Bag 1320
University of Tasmania
Launceston, Tasmania, 7250
Country 40316 0
Australia
Phone 40316 0
+61 3 6324 3137
Fax 40316 0
Email 40316 0
Mai.Frandsen@utas.edu.au

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.