Condition category
Mental and Behavioural Disorders
Date applied
08/06/2006
Date assigned
11/09/2006
Last edited
22/11/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Aziz Sheikh

ORCID ID

Contact details

Professor of Primary Care Research & Development
Division of Community Health Sciences: GP Section
University of Edinburgh
20 West Richmond Street
Edinburgh
EH8 9DX
United Kingdom
Aziz.sheikh@ed.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G0501288

Study information

Scientific title

Acronym

Study hypothesis

As of 02/07/2007:
The aims of this work are to:
1. Refine two ('clinic' and 'clinic + outreach') models of using trained community smoking cessation workers to deliver smoking cessation services (Phase 1)
2. Conduct a pilot randomised controlled trial comparing the likely uptake and effectiveness of these models of care (Phase II of the complex interventions framework)

Previous hypotheses:
The aims of this work are to:
1. Refine two ('clinic' and 'clinic + outreach') models of using trained community smoking cessation workers to deliver smoking cessation services (Phase 1)
2. Conduct a pilot randomised controlled trial comparing the likely uptake and effectiveness of these models of care with standard care (Phase II of the complex interventions framework)

Ethics approval

Received from South Staffordshire LREC in April 2007 (ref: 06/Q2602/57).

Study design

Pilot randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Smoking cessation

Intervention

Please note that as of 02/07/2007 the start date of this trial was changed to 01/10/2006, and the anticipated end date of this trial has been changed to 30/09/2008.

Current interventions as of 02/07/2007:
'The interventions to be tested in this two arm pilot trial are:
1. Trained community smoking cessation officer based in smoking cessation clinic ('clinic only')
2. Trained smoking cessation facilitator working in the clinic and also in an outreach capacity with clients in a location of their choosing ('clinic + outreach')

Previous interventions:
The interventions to be tested in this three arm pilot trial are:
1. Standard care (control)
2. Trained community smoking cessation officer based in smoking cessation clinic ('clinic only')
3. Trained smoking cessation facilitator working in the clinic and also in an outreach capacity with clients in a location of their choosing ('clinic + outreach')

Intervention type

Other

Phase

Phase I/II

Drug names

Primary outcome measures

Our main overall outcome of interest for this work is to refine, pilot and have the data needed to inform sample size calculations for a definitive trial evaluating these interventions.

Secondary outcome measures

Added as of 02/07/2007:
1. Patient adherence to pharmacotherapy
2. Patient satisfaction with the stop smoking service accessed

Overall trial start date

01/03/2006

Overall trial end date

28/02/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. All consenting self-assigned (using Census 2001 categories) Pakistani and Bangladeshi adults (18 years or older)
2. Regular smokers (defined as self-declared usage of on average more than or equal to one cigarette/day) who want to quit

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

180

Participant exclusion criteria

Those unwilling or unable to give informed consent will be excluded.

Recruitment start date

01/03/2006

Recruitment end date

28/02/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Professor of Primary Care Research & Development
Edinburgh
EH8 9DX
United Kingdom

Sponsor information

Organisation

University of Edinburgh (UK)

Sponsor details

College of Medicine and Veterinary Medicine Office
The Queen's Medical Research Institute
47 Little France Crescent
Edinburgh
EH16 4TJ
United Kingdom
paulmcg@miscorp.ed.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Prevention Research Initiative (NPRI) (UK) (ref: G0501288)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2009 protocol in http://www.ncbi.nlm.nih.gov/pubmed/19682374
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21854596

Publication citations

  1. Protocol

    Begh RA, Aveyard P, Upton P, Bhopal RS, White M, Amos A, Prescott RJ, Bedi R, Barton P, Fletcher M, Gill P, Zaidi Q, Sheikh A, Promoting smoking cessation in Bangladeshi and Pakistani male adults: design of a pilot cluster randomised controlled trial of trained community smoking cessation workers., Trials, 2009, 10, 71, doi: 10.1186/1745-6215-10-71.

  2. Results

    Begh RA, Aveyard P, Upton P, Bhopal RS, White M, Amos A, Prescott RJ, Bedi R, Barton P, Fletcher M, Gill P, Zaidi Q, Sheikh A, Promoting smoking cessation in Pakistani and Bangladeshi men in the UK: pilot cluster randomised controlled trial of trained community outreach workers., Trials, 2011, 12, 197, doi: 10.1186/1745-6215-12-197.

Additional files

Editorial Notes