Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000465257
Ethics application status
Approved
Date submitted
2/06/2009
Date registered
16/06/2009
Date last updated
3/02/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial examining the efficacy of a smoking cessation intervention initiated during psychiatric hospitalisation on post-discharge smoking reduction, nicotine dependence and abstinence.
Scientific title
The effect of an integrated smoking care program on the reduction and abstinence of smoking in mental health inpatients following discharge from hospital.
Secondary ID [1] 253136 0
New secondary ID. Please modify.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Smoking 4828 0
Mental health 236970 0
Condition category
Condition code
Public Health 237170 237170 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
*Provision of 3 quit smoking pamphlets upon recruitment to the intervention condition
*Active referral to the telephone support Quitline (occurring once at discharge from hospital)
*Up to 16 weeks provision of Nicotine Replacement Therapy (NRT), including patches, Gum, lozenges and Inhalers.
* A weekly, one hour smoking support group (occurring for 4 weeks in total)
* A one page referral to a general practitioner (GP) and other health professionals (for example psychologists, occupational therapists) to inform them of their clients participation in a smoking study.
*Telephone support calls, made once every two weeks for up to 4 months.
Intervention code [1] 4593 0
Treatment: Other
Comparator / control treatment
Control group will receive standard hospital care for treatment of smoking.
This care entails provision of nicotine replacement therapy (NRT), including gum, lozenges, inhalers and patches continuously for the duration of the hospital stay.
Upon discharge, patients are 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] 238023 0
Changes in smoking behaviour, including reduction in daily cigarette consumption and number and duration of quit attempts assessed by self-report and collaborative reports from smoking group facilitators. Detailed process data will also be collected, including uptake and use of smoking cessation supports, allowing researchers to determine the feasibility and acceptability of linking inpatient to community cessation support.
Timepoint [1] 238023 0
All participants will be followed up via telephone survey at 1 week, 2 months, 4 months and 6 months post discharge.
Secondary outcome [1] 242168 0
Abstinence from smoking, assessed by self-report and collaborative reports from smoking group facilitators. A small percentage (5%) of those who have indicated to be abstinent will be asked to complete a Carbon Monoxide (CO) test to confirm this.
Timepoint [1] 242168 0
All participants will be followed up via telephone survey at 1 week, 2 months, 4 months and 6 months post discharge.

Eligibility
Key inclusion criteria
Inpatient at mental health hospital, smoker.
Minimum age
18 Years
Maximum age
No limit
Sex
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)
Prior to commencement of recruitment, a random allocation sequence will be generated using SPSS through consultation with an independent statistician not actively involved in the project. The random allocation sequence will be stored with a research assistant independent of the recruitment process, and all project officers involved in recruitment and follow-up data collection will be kept blind to the sequence. According to the order of the random allocation sequence, the research assistant will place small cards indicating the treatment condition (“Intervention” or “Control”) inside sealed, security envelopes, displaying the sequentially ordered participant identification code on the exterior. Following completion of the baseline interview, the project officer will provide the participant with the subsequent envelope in sequence, and the envelope will be opened by the participant at the conclusion of the baseline interview.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



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
17/06/2009
Actual
30/10/2009
Date of last participant enrolment
Anticipated
Actual
30/05/2011
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] 237085 0
Charities/Societies/Foundations
Name [1] 237085 0
Australian Rotary Health Research Fund
Country [1] 237085 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive, Callaghan 2308 NSW
Country
Australia
Secondary sponsor category [1] 4590 0
None
Name [1] 4590 0
Address [1] 4590 0
Country [1] 4590 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239187 0
University of Newcastle Human research Ethics Committee
Ethics committee address [1] 239187 0
Ethics committee country [1] 239187 0
Australia
Date submitted for ethics approval [1] 239187 0
Approval date [1] 239187 0
18/07/2008
Ethics approval number [1] 239187 0
H-2008-0191

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

Contacts
Principal investigator
Name 29617 0
A/Prof Jenny Bowman
Address 29617 0
School of Psychology, University of Newcastle, University Drive, Callaghan, NSW, 2308
Country 29617 0
Australia
Phone 29617 0
+61 2 49215958
Fax 29617 0
Email 29617 0
[email protected]
Contact person for public queries
Name 12864 0
AProf Jenny Bowman
Address 12864 0
School of Psychology
University of Newcastle, University Drive, Callaghan 2308 NSW
Country 12864 0
Australia
Phone 12864 0
+61 2 49215958
Fax 12864 0
Email 12864 0
[email protected]
Contact person for scientific queries
Name 3792 0
AProf Jenny Bowman
Address 3792 0
School of Psychology
University of Newcastle, University Drive, Callaghan 2308 NSW
Country 3792 0
Australia
Phone 3792 0
+61 2 49215958
Fax 3792 0
Email 3792 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.