Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000091404
Ethics application status
Approved
Date submitted
2/01/2007
Date registered
29/01/2007
Date last updated
29/01/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Opportunistic referral of smokers to telephone cessation advice from a nurse: a randomised trial in Australian general practice
Scientific title
Randomised trial of the effectiveness of opportunistic referral of smokers attending Australian general practice for telephone-based smoking cessation advice from a nurse to improve quit rates and stage of change at six and twelve months
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Smokers 1589 0
Condition category
Condition code
Public Health 1691 1691 0 0
Health service research
Mental Health 1692 1692 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Smokers received up to 4 telephone contacts over 4-8 weeks from a trained nurse: 1)within 3 days of consultation for assessment, motivational advice and planning of quit attempt; 2) on quit date; 3)one week after quit date; 4) 3 weeks after quit date. Calls made by the nurse. Patients could withdraw from the intervention at any time but all patients were contacted for follow-up data.
Intervention code [1] 1531 0
Behaviour
Comparator / control treatment
Usual care: brief advice +/- written cessation materials at discretion of GP.
Control group
Active

Outcomes
Primary outcome [1] 2344 0
Quit rates.
Timepoint [1] 2344 0
6 and 12 months.
Secondary outcome [1] 4077 0
Shifts in stage of change
Timepoint [1] 4077 0
six and twelve months

Eligibility
Key inclusion criteria
Smokers attending routine consultations in general practice were eligible.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusions: insufficient English, cognitive impairment, unable to complete questionnaire

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)
Allocation not concealed (but questionnaires numbered sequentially and pre-randomised. Unobtrusive mark indicated group allocation. Log maintained of questionnaire number and actual group allocation)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
control group patients received usual care
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
318
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1832 0
Charities/Societies/Foundations
Name [1] 1832 0
National Heart Foundation of Australia
Country [1] 1832 0
Australia
Primary sponsor type
Individual
Name
Dr Jane Young
Address
Country
Secondary sponsor category [1] 1651 0
None
Name [1] 1651 0
None
Address [1] 1651 0
Country [1] 1651 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3429 0
Sydney South West Area Health Service
Ethics committee address [1] 3429 0
Ethics committee country [1] 3429 0
Australia
Date submitted for ethics approval [1] 3429 0
Approval date [1] 3429 0
26/08/2002
Ethics approval number [1] 3429 0
02/098
Ethics committee name [2] 3430 0
Central Sydney Area Health Service Ethics Review Committee (RPAH zone)
Ethics committee address [2] 3430 0
Ethics committee country [2] 3430 0
Australia
Date submitted for ethics approval [2] 3430 0
Approval date [2] 3430 0
14/02/2001
Ethics approval number [2] 3430 0
X01-0034

Summary
Brief summary
This trial investigated the effectiveness of opportunistic referral of smokers by their GP to telephone cessation counselling by a trained nurse to improve quit rates and shifts in stage of change at six and twelve months. The trial also investigated the acceptability of the intervention to patients and GPs. Intervention group patients were offered a telephone-based program delivered by a nurse comprising assessment and stage-based behavioural advice, written information and follow-up. Control group patients received ‘usual care’.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27465 0
Address 27465 0
Country 27465 0
Phone 27465 0
Fax 27465 0
Email 27465 0
Contact person for public queries
Name 10720 0
Dr Jane Young
Address 10720 0
Surgical Outcomes Research Centre
Sydney South West Area Health Service (SSWAHS)
PO Box M157
Missenden Rd
Camperdown NSW 2050
Country 10720 0
Australia
Phone 10720 0
+61 2 95159095
Fax 10720 0
+61 2 95159091
Email 10720 0
[email protected]
Contact person for scientific queries
Name 1648 0
Dr Jane Young
Address 1648 0
Surgical Outcomes Research Centre
Sydney South West Area Health Service (SSWAHS)
PO Box M157
Missenden Rd
Camperdown NSW 2050
Country 1648 0
Australia
Phone 1648 0
+61 2 95159095
Fax 1648 0
+61 2 95159091
Email 1648 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.