Promoting smoking cessation in Bangladeshi and Pakistani male adults: pilot randomised controlled trial

ISRCTN	ISRCTN82127540
DOI	https://doi.org/10.1186/ISRCTN82127540
Secondary identifying numbers	G0501288

Submission date: 08/06/2006
Registration date: 11/09/2006
Last edited: 22/11/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Prof Aziz Sheikh
Scientific

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

Email	Aziz.sheikh@ed.ac.uk

Study information

Study design	Pilot randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
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(s)	Received from South Staffordshire LREC in April 2007 (ref: 06/Q2602/57).
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
Primary outcome measure	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 study start date	01/03/2006
Overall study end date	28/02/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Male
Target number of participants	180
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 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

Scotland
United Kingdom

Study participating centre

Professor of Primary Care Research & Development

Edinburgh
EH8 9DX
United Kingdom

Sponsor information

University of Edinburgh (UK)
University/education

College of Medicine and Veterinary Medicine Office
The Queen's Medical Research Institute
47 Little France Crescent
Edinburgh
EH16 4TJ
Scotland
United Kingdom

Email	paulmcg@miscorp.ed.ac.uk
"ROR"	https://ror.org/01nrxwf90

Funders

Funder type

Government

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	14/08/2009		Yes	No
Results article	results	19/08/2011		Yes	No