ANZCTR - Registration

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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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

tobacco dependence

Condition category

Condition code

Mental Health

Addiction

Public Health

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]

Behaviour

Comparator / control treatment

Minimal intervention control consisting of a web link to static smoking cessation resources

Control group

Active

Outcomes

Primary outcome [1]

6-month sustained abstinence from smoking, assessed by telephone interview.

Timepoint [1]

7 months after randomisation.

Secondary outcome [1]

Point prevalence abstinence from smoking, assessed by telephone interview.

Timepoint [1]

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?

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]

Government body

Name [1]

National Health & Medical Research Council

Address [1]

GPO Box 1421, Canberra AVT 2601

Country [1]

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]

Charities/Societies/Foundations

Name [1]

The Cancer Council Victoria

Address [1]

The Cancer Council Victoria, 615 St Kilda Rd, Melbourne VIC 3004

Country [1]

Australia

Other collaborator category [1]

Individual

Name [1]

Dr James Balmford

Address [1]

The Cancer Council Victoria, 615 St Kilda Rd, Melbourne VIC 3004

Country [1]

Australia

Other collaborator category [2]

Individual

Name [2]

Assoc Prof Steve Howard

Address [2]

Department of Information Systems, University of Melbourne

Country [2]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Cancer Council Victoria Human Research Ethics Committee

Ethics committee address [1]

The Cancer Council Victoria,
1 Rathdowne St Carlton VIC 3053

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

13/01/2006

Ethics approval number [1]

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

Prof Ron Borland

Address

The Cancer Council Victoria, 615 St Kilda Rd, Melbourne VIC 3004

Country

Australia

Phone

+ 61 3 9514 6291

Fax

Ron.Borland@cancervic.org.au

Contact person for public queries

Name

Ron Borland

Address

The Cancer Council Victoria, 615 St Kilda Rd Melbourne VIC 3004

Country

Australia

Phone

+ 61 3 9514 6291

Fax

James.Balmford@cancervic.org.au

Contact person for scientific queries

Name

Prof Ron Borland

Address

The Cancer Council Victoria, 615 St Kilda Rd Melbourne VIC 3004

Country

Australia

Phone

+ 61 3 9514 6291

Fax

Ron.Borland@cancervic.org.au

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

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Documents added automatically

No additional documents have been identified.

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