Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000221550
Ethics application status
Approved
Date submitted
25/05/2006
Date registered
2/06/2006
Date last updated
29/04/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effectiveness of proactive telemarketing of a smoking cessation telephone counselling service
Scientific title
The effect of proactive telephone counselling on the quitting rates of non-volunteer smokers
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Addiction to tobacco smoking 1199 0
Condition category
Condition code
Public Health 1284 1284 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Daily smokers will be allocated to either an intervention group or control group. The intervention group will receive telephone counselling for smoking cessation. On average, 4 telephone counselling sessions of approximately 10 minutes duration will be delivered to intervention participants. The number of sessions range from 1-12 calls over a 3 month period according to a client directed relapse responsive schedule.
Intervention code [1] 1070 0
Prevention
Comparator / control treatment
The control group participants will receive a one-off mail-out of written self-help materials.
Control group
Active

Outcomes
Primary outcome [1] 1740 0
Point prevalence abstinence
Timepoint [1] 1740 0
Measured at 4, 7 and 13 months post-recruitment
Primary outcome [2] 1741 0
Prolonged abstinence
Timepoint [2] 1741 0
Measured at 4, 7 and 13 months post-recruitment
Secondary outcome [1] 3096 0
Tobacco consumption reduction
Timepoint [1] 3096 0
Measured at 4, 7 and 13 months post-recruitment.

Eligibility
Key inclusion criteria
Adult residents of NSWdaily smoker.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those residing outside of NSWoccasional and non-smokers.

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)
Central randomisation by computer
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 (ie, computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
13/09/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1216
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1407 0
Government body
Name [1] 1407 0
Australian Research Council
Country [1] 1407 0
Australia
Funding source category [2] 1408 0
Charities/Societies/Foundations
Name [2] 1408 0
National Heart Foundation
Country [2] 1408 0
Australia
Funding source category [3] 1409 0
Government body
Name [3] 1409 0
Hunter New England Population Health
Country [3] 1409 0
Australia
Funding source category [4] 1410 0
Charities/Societies/Foundations
Name [4] 1410 0
The Cancer Council NSW
Country [4] 1410 0
Australia
Primary sponsor type
University
Name
Centre for Health Research & Psycho-oncology
Address
Longworth Avenue, Wallsend NSW 2287
Country
Australia
Secondary sponsor category [1] 1236 0
Government body
Name [1] 1236 0
Hunter New England Population Health
Address [1] 1236 0
Longworth Avenue, Wallsend NSW 2287
Country [1] 1236 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2766 0
The University of Newcastle
Ethics committee address [1] 2766 0
Ethics committee country [1] 2766 0
Australia
Date submitted for ethics approval [1] 2766 0
Approval date [1] 2766 0
Ethics approval number [1] 2766 0
H-883-0904
Ethics committee name [2] 2767 0
Hunter New England Area Health Service
Ethics committee address [2] 2767 0
Ethics committee country [2] 2767 0
Australia
Date submitted for ethics approval [2] 2767 0
Approval date [2] 2767 0
Ethics approval number [2] 2767 0
05/04/13/3.19

Summary
Brief summary
Households are selected at random from the New South Wales Electronic White Pages. Each household is contacted by telephone to establish if there is an adult daily smoker resident. If more then one daily smoker lives in the household one smoker is selected at random. Consenting smokers are randomly allocated to receive either proactive telephone counselling calls or a one-off mail-out of written self-help materials. The assessor (ie, telephone interviewer) is unaware of group assignment as computer software allocates participants to conditions. Participants complete telephone interviews at 4, 7 and 13 months post-recruitment to examine quitting behaviours. It is hypothesised that compared to the written self-help group, significantly more participants in the telephone counselling group will have quit smoking at 4, 7 and 13 months post-recruitment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35998 0
Address 35998 0
Country 35998 0
Phone 35998 0
Fax 35998 0
Email 35998 0
Contact person for public queries
Name 10259 0
Flora Tzelepis
Address 10259 0
Centre for Health Research and Psycho-oncology
Locked bag 10
Wallsend NSW 2287
Country 10259 0
Australia
Phone 10259 0
+61 2 49246298
Fax 10259 0
+61 2 49246208
Email 10259 0
[email protected]
Contact person for scientific queries
Name 1187 0
Dr Christine Paul
Address 1187 0
Centre for Health Research and Psycho-oncology
Locked bag 10
Wallsend NSW 2287
Country 1187 0
Australia
Phone 1187 0
+61 2 49246368
Fax 1187 0
+61 2 49246208
Email 1187 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.