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Trial registered on ANZCTR


Registration number
ACTRN12612001042831
Ethics application status
Approved
Date submitted
27/09/2012
Date registered
28/09/2012
Date last updated
2/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the efficacy of an integrated smoking cessation intervention for mental health patients: a randomised controlled trial.
Scientific title
Evaluating the efficacy of an integrated smoking cessation intervention for mental health patients: a randomised controlled trial.
Secondary ID [1] 281286 0
Pilot registration ID: ACTRN12609000465257
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Smoking 287532 0
Mental health 287533 0
Condition category
Condition code
Public Health 287854 287854 0 0
Other public health
Mental Health 287856 287856 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In inpatient setting:
- 10-15 minute motivational interview
- 3 quit smoking pamphlets tailored to people with mental illness

On discharge:
NRT discharge pack

In the community:
- Up to 12 weeks provision of Nicotine Replacement Therapy (NRT), including patches, gum, lozenges, inhalers and oral spray
- 16 weeks of telephone support. These will be delivered weekly between weeks 1 and 4, weekly or fortnightly (participant preference) between weeks 5 and 12, and fortnightly between weeks 12 and 16.
- Proactive referral to Quitline
- A one page letter to participants general practitioners (GP) and other mental health professionals outlining their clients participation the study.
Intervention code [1] 285780 0
Treatment: Other
Comparator / control treatment
Control group will receive standard hospital care for treatment of smoking. This care may entail provision of nicotine replacement therapy (NRT), including gum, lozenges, inhalers and patches continuously for the duration of the hospital stay. Upon discharge, patients may be given the option to receive an active referral to Quitline, and 3 days supply of 21mg/24 hour patches.
Control group
Active

Outcomes
Primary outcome [1] 288076 0
Abstinence from smoking (both point prevalence and continuous) assessed via self-report with biochemical verification (CO).
Timepoint [1] 288076 0
All participants will be followed up via telephone survey at 1, 6 and 12 months post discharge.
Secondary outcome [1] 299378 0
Changes in smoking behavior, including reduction in daily cigarette consumption, number and duration of quit attempts, and readiness to quit. Detailed process data will also be collected, these include the uptake and use of smoking cessation supports.
Timepoint [1] 299378 0
All participants will be followed up via telephone survey at 1, 6 and 12 months post discharge.

Eligibility
Key inclusion criteria
- individual admitted to mental health inpatient facility
- smokes cigarettes
- capacity to give informed consent
- can provide contact details to facilitate communication post discharge.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Non-smoker

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 5803 0
2430
Recruitment postcode(s) [2] 5804 0
2298
Recruitment postcode(s) [3] 5805 0
2320
Recruitment postcode(s) [4] 5806 0
2348

Funding & Sponsors
Funding source category [1] 286073 0
Government body
Name [1] 286073 0
National Health and Medical Research Council
Address [1] 286073 0
Level 1
16 Marcus Clarke Street
Canberra ACT 2601
Country [1] 286073 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 284889 0
Government body
Name [1] 284889 0
Hunter New England Population Health
Address [1] 284889 0
Longworth Ave, Wallsend, NSW 2287, Australia
Country [1] 284889 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288124 0
Hunter New England Research Ethics Committee
Ethics committee address [1] 288124 0
Hunter New England Health Research Ethics Unit
Administration Building
Lookout Road
New Lambton NSW 2305
Ethics committee country [1] 288124 0
Australia
Date submitted for ethics approval [1] 288124 0
Approval date [1] 288124 0
15/02/2012
Ethics approval number [1] 288124 0
11/12/14/4.02
Ethics committee name [2] 291358 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [2] 291358 0
University Drive, Callaghan, NSW 2308, Australia
Ethics committee country [2] 291358 0
Australia
Date submitted for ethics approval [2] 291358 0
Approval date [2] 291358 0
10/12/2012
Ethics approval number [2] 291358 0
H-2012-0061

Summary
Brief summary
The efficacy of a smoking cessation intervention initiated during a mental health hospital admission and continued post discharge will be assessed via randomised controlled trial. At 12 months post-test, it is hypothesised that participants receiving the intervention will have a 10% points higher 7-day point prevalence abstinence from smoking (20%) as compared to participants that did not (10%), and a 4% points higher prevalence of prolonged abstinence (5%, as compared to 1%).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34747 0
A/Prof Jenny Bowman
Address 34747 0
School of Psychology University of Newcastle, University Drive, Callaghan NSW 2308
Country 34747 0
Australia
Phone 34747 0
+61 2 49215958
Fax 34747 0
Email 34747 0
jenny.bowman@newcastle.edu.au
Contact person for public queries
Name 17994 0
A/Prof Jenny Bowman
Address 17994 0
School of Psychology
University of Newcastle,
University Drive,
Callaghan NSW 2308
Country 17994 0
Australia
Phone 17994 0
+61 2 49215958
Fax 17994 0
+ 612 4921 6980
Email 17994 0
jenny.bowman@newcastle.edu.au
Contact person for scientific queries
Name 8922 0
A/Prof Jenny Bowman
Address 8922 0
School of Psychology
University of Newcastle,
University Drive,
Callaghan NSW 2308
Country 8922 0
Australia
Phone 8922 0
+61 2 49215958
Fax 8922 0
+ 612 4921 6980
Email 8922 0
jenny.bowman@newcastle.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary