Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000885291
Ethics application status
Approved
Date submitted
25/09/2009
Date registered
12/10/2009
Date last updated
25/06/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Delivering a personalised smoking cessation intervention by community pharmacists in Western Australia: a pilot, randomised controlled trial.
Scientific title
For smokers is the combination of photoageing software plus community pharmacy counselling more effective than community pharmacy counselling alone for prompting quit attempts?
Secondary ID [1] 280726 0
NIL
Universal Trial Number (UTN)
U1111-1111-9869
Trial acronym
PAINT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
tobacco smoking 251912 0
Condition category
Condition code
Public Health 252105 252105 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will receive 'one on one' standard smoking cessation advice by a pharmacist. This will comprise of them receiving a Pharmacy Self Care card on Smoking (a health information card from the Pharmacy Self Care Program of the Pharmaceutical Society of Australia) and verbal counselling from the pharmacist. They will be asked to complete a Baseline questionnaire. Then they will also be photographed and their images digitally aged, as a smoker and non-smoker, using APRIL Age software and invited to view the age-processed images. (They will receive a copy of their digitally aged photos to keep). All of this will be done once only (baseline) and will take approximately 10 minutes to complete.
Intervention code [1] 241333 0
Prevention
Comparator / control treatment
Participants will receive 'one on one' standard smoking cessation advice by a pharmacist. This will comprise of them receiving a Pharmacy Self Care card on Smoking (a health information card from the Pharmacy Self Care program of the Pharmaceutical Society of Australia) and verbal counselling from the pharmacist. They will be asked to complete a Baseline questionnaire. All of this will be done once only (baseline) and will take approximately 5 minutes to complete.
Control group
Active

Outcomes
Primary outcome [1] 252986 0
Successful quitting: this will be assessed by follow-up questionnaire surveys undertaken via telephone and biochemical verification of non-smoking status at the final 6 month follow-up.
Timepoint [1] 252986 0
At 1, 3 and 6 months from baseline.
Primary outcome [2] 252997 0
Number of quit attempts: this will be assessed by follow-up questionnaire surveys undertaken via telephone and biochemical verification of non-smoking status at the final 6 month follow-up.
Timepoint [2] 252997 0
At 1, 3 and 6 months from baseline.
Secondary outcome [1] 257753 0
'State of change' progression attitudes: this will be assessed by the "Fagerstrom Scale: How addicted are you to nicotine?" questionnaire.
Timepoint [1] 257753 0
At 1, 3 and 6 months from baseline.

Eligibility
Key inclusion criteria
- Daily smokers - able to give informed consent - contact availability for 6 months
Minimum age
18 Years
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- people with beards, moustaches or facial accessories that can't be removed
- people with Body Dysmorphic Disorder as defined by the Body Dysmorphic Disorder Questionnaire (BDDQ)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants recruited from customers who enter community pharmacies participating in the study. Allocation to the intervention or control group will be randomised into two groups: control group and intervention group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation into control and intervention group will alternate weekly (most feasible and least bias option suitable for the different community pharmacy settings) so that all clients recruited in any specific week will receive the same intervention.
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
Completed
Date of first participant enrolment
Anticipated
10/01/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2136 0
6005
Recruitment postcode(s) [2] 2137 0
6025
Recruitment postcode(s) [3] 2138 0
6051
Recruitment postcode(s) [4] 2139 0
6027
Recruitment postcode(s) [5] 2140 0
6062
Recruitment postcode(s) [6] 2141 0
6153
Recruitment postcode(s) [7] 2142 0
6164
Recruitment postcode(s) [8] 2143 0
6157
Recruitment postcode(s) [9] 2144 0
6107
Recruitment postcode(s) [10] 2145 0
6018

Funding & Sponsors
Funding source category [1] 243793 0
University
Name [1] 243793 0
Curtin University
Country [1] 243793 0
Australia
Primary sponsor type
Individual
Name
Professor Moyez Jiwa
Address
Curtin Health Innovation Research Institute, Curtin University GPO Box U1987 Perth WA 6845
Country
Australia
Secondary sponsor category [1] 237150 0
Individual
Name [1] 237150 0
Associate Professor Owen Carter
Address [1] 237150 0
Office of the Pro-Vice Chancellor (Health Advancement), Edith Cowan University, Joondalup Drive, Joondalup
Country [1] 237150 0
Australia
Secondary sponsor category [2] 237161 0
Individual
Name [2] 237161 0
Oksana Burford
Address [2] 237161 0
School of Pharmacy, Curtin Health Innovation Research Institute, Curtin University, GPO Box U1987 Perth WA 6845
Country [2] 237161 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243922 0
Human Research Ethics Committee
Ethics committee address [1] 243922 0
Ethics committee country [1] 243922 0
Australia
Date submitted for ethics approval [1] 243922 0
Approval date [1] 243922 0
21/07/2009
Ethics approval number [1] 243922 0
HR 01/2008

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

Contacts
Principal investigator
Name 30322 0
Address 30322 0
Country 30322 0
Phone 30322 0
Fax 30322 0
Email 30322 0
Contact person for public queries
Name 13569 0
Professor Moyez Jiwa
Address 13569 0
CHIRI
GPO Box U1987
Perth WA 6845
Country 13569 0
Australia
Phone 13569 0
+61 8 9266 1768
Fax 13569 0
+61 8 9266 1642
Email 13569 0
[email protected]
Contact person for scientific queries
Name 4497 0
Associate Professor Owen Carter
Address 4497 0
Office of the Pro-Vice Chancellor (Health Advancement), Edith Cowan University, Joondalup Drive, Joondalup
Country 4497 0
Australia
Phone 4497 0
+61 8 6304 3433
Fax 4497 0
+61 8 6304 5577
Email 4497 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.