Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000282381
Ethics application status
Approved
Date submitted
30/05/2008
Date registered
2/06/2008
Date last updated
22/04/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Equit: A study of how smokers use electronic communication tools to help them quit smoking.
Scientific title
Randomised trial of the QuitCoach interactive personalised advice, Quit onQ text messaging program, and an integration of the two (QuitCoach onQ); tobacco dependence; smoking cessation as defined by 6-month sustained abstinence.
Secondary ID [1] 286580 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
tobacco dependence 3199 0
Condition category
Condition code
Mental Health 3361 3361 0 0
Addiction
Public Health 3362 3362 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
QuitCoach Internet-based interactive tailored advice designed to be used on multiple occasions; Quit onQ text messaging which sends a tailored program of 1-8 messages daily for approximately 1 month; QuitCoach onQ integrated program consisting of daily messages plus use of the QuitCoach if more comprehensive assistance is desired.
Intervention code [1] 2935 0
Behaviour
Comparator / control treatment
Minimal intervention control consisting of a web link to static smoking cessation resources
Control group
Active

Outcomes
Primary outcome [1] 4247 0
6-month sustained abstinence from smoking, assessed by telephone interview.
Timepoint [1] 4247 0
7 months after randomisation.
Secondary outcome [1] 7179 0
Point prevalence abstinence from smoking, assessed by telephone interview.
Timepoint [1] 7179 0
7 months after randomisation.

Eligibility
Key inclusion criteria
Current smoker, or quit within the last week.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Not using any extensive interactive computer-delivered or person-delivered cessation program, no reported condition requiring referral to an in-person service.

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Recruitment into trial independent of offer of randomised intervention offer
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2008
Actual
13/11/2008
Date of last participant enrolment
Anticipated
Actual
2/11/2009
Date of last data collection
Anticipated
Actual
Sample size
Target
3600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3436 0
Government body
Name [1] 3436 0
National Health & Medical Research Council
Country [1] 3436 0
Australia
Primary sponsor type
Individual
Name
Professor Ron Borland
Address
The Cancer Council Victoria, 615 St Kilda Rd, Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 3078 0
Charities/Societies/Foundations
Name [1] 3078 0
The Cancer Council Victoria
Address [1] 3078 0
The Cancer Council Victoria, 615 St Kilda Rd, Melbourne VIC 3004
Country [1] 3078 0
Australia
Other collaborator category [1] 296 0
Individual
Name [1] 296 0
Dr James Balmford
Address [1] 296 0
The Cancer Council Victoria, 615 St Kilda Rd, Melbourne VIC 3004
Country [1] 296 0
Australia
Other collaborator category [2] 297 0
Individual
Name [2] 297 0
Assoc Prof Steve Howard
Address [2] 297 0
Department of Information Systems, University of Melbourne
Country [2] 297 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5460 0
The Cancer Council Victoria Human Research Ethics Committee
Ethics committee address [1] 5460 0
The Cancer Council Victoria,
1 Rathdowne St Carlton VIC 3053
Ethics committee country [1] 5460 0
Australia
Date submitted for ethics approval [1] 5460 0
Approval date [1] 5460 0
13/01/2006
Ethics approval number [1] 5460 0
HREC 0510

Summary
Brief summary
The aim of the project is to design, implement and evaluate programs that use both Internet and telephone/communications technology to automate the provision of tailored smoking cessation assistance. In particular, the research is interested in the relative effectiveness of detailed advice (as provided through a web-based expert system) as compared with the capacity of modern messaging technology (SMS) to provide a set of prompts and reminders to help smokers manage a quit attempt and prevent relapse. The project is an innovative collaboration between a team with expertise in the development of mass-deliverable smoking cessation interventions, and a team with expertise in human-computer interaction (HCI), which is concerned with optimizing use of computing and communication technology. Using principles of HCI, smokers will be actively involved in the development of the programs through an interative process of review consisting of a series of user-based evaluations, design workshops and field trials. In this way, real-world use and acceptability of the interventions will be assessed and reviewed until we have developed the best possible prototypes. Following this process, a large-scale randomised controlled trial will be conducted to evaluate the relative effectiveness and cost-effectiveness of each of the interventions both individually and combined, against a control condition receiving minimal cessation assistance. It is hypothesized that all intervention programs will be more effective than minimal assistance, with the Combined program proving most effective, especially among smokers who are more addicted and/or have had no previous quit attempt lasting beyond a week.
Trial website
www.equit.org.au
Trial related presentations / publications
Balmford, J. & Borland, R. (2014). How do smokers use a text messaging to quit intervention? Nicotine & Tobacco Research, 16, 1586-1592.

Borland, R., Balmford, J., Benda, P. (2013). Population-level effects of automated smoking cessation help programs: a randomised controlled trial. Addiction, 108, 618-628.

Balmford, J., Borland, R., Benda, P., Howard, S. (2013). Factors associated with use of automated interventions: Findings from the eQuit study. Health Education Research, 28, 288-299.

Borland, R. & Balmford J. (2012). Population-level effects of automated cessation help programs: A randomised controlled trial. 15th World Conference Tobacco or Health, Singapore, 20-24 March.

Balmford, J., Borland, R., Benda, P. (2008). Patterns of use of an automated interactive personalised coaching program for smoking cessation. Journal of Medical Internet Research, 10(5), e54.

Balmford, J., Borland, R., Benda, P., Graham, C., Howard, S. (2008). Augmenting the QuitCoach and adding messaging capacity. 9th Behavioural Research in Cancer Control Conference, Melbourne, Australia, 9-11 April.

Graham, C., Benda, P., Howard, S., Balmford, J., Bishop, N., Borland, R. (2006). "heh - keeps me off the smokes..": probing technology support for personal change. In Proceedings of the 20th Conference of the Computer-Human Interaction Special Interest Group (Chisig) of Australia on Computer-Human Interaction: Design: Activities, Artefacts and Environments (Sydney, Australia, November 20 - 24, 2006). OZCHI '06, vol. 206. ACM, New York, NY, 221-228.
Public notes

Contacts
Principal investigator
Name 28623 0
Prof Ron Borland
Address 28623 0
The Cancer Council Victoria, 615 St Kilda Rd, Melbourne VIC 3004
Country 28623 0
Australia
Phone 28623 0
+ 61 3 9514 6291
Fax 28623 0
Email 28623 0
Ron.Borland@cancervic.org.au
Contact person for public queries
Name 11780 0
Prof Ron Borland
Address 11780 0
The Cancer Council Victoria, 615 St Kilda Rd Melbourne VIC 3004
Country 11780 0
Australia
Phone 11780 0
+ 61 3 9514 6291
Fax 11780 0
Email 11780 0
James.Balmford@cancervic.org.au
Contact person for scientific queries
Name 2708 0
Prof Prof Ron Borland
Address 2708 0
The Cancer Council Victoria, 615 St Kilda Rd Melbourne VIC 3004
Country 2708 0
Australia
Phone 2708 0
+ 61 3 9514 6291
Fax 2708 0
Email 2708 0
Ron.Borland@cancervic.org.au

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