|
Welcome
|
|
23 May 2012
|
|
|
| home | my details | ISRCTN Register | mRCT | links | information | press |
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
| [ Print-friendly version ] |
| Promoting smoking cessation in Bangladeshi and Pakistani male adults: pilot randomised controlled trial |
| ISRCTN | ISRCTN82127540 |
| ClinicalTrials.gov identifier | |
| Public title | Promoting smoking cessation in Bangladeshi and Pakistani male adults: pilot randomised controlled trial |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | G0501288 |
| 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) |
| Lay summary | Not provided at time of registration |
| Ethics approval | Received from South Staffordshire LREC in April 2007 (ref: 06/Q2602/57). |
| Study design | Pilot randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Smoking cessation |
| Participants - 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 |
| Participants - exclusion criteria | Those unwilling or unable to give informed consent will be excluded. |
| Anticipated start date | 01/03/2006 |
| Anticipated end date | 28/02/2008 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 180 |
| Interventions |
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') |
| Primary outcome measure(s) | 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 measure(s) |
Added as of 02/07/2007:
1. Patient adherence to pharmacotherapy 2. Patient satisfaction with the stop smoking service accessed |
| Sources of funding | National Prevention Research Initiative (NPRI) (UK) (ref: G0501288) |
| Trial website | |
| Publications |
1. 2009 protocol in http://www.ncbi.nlm.nih.gov/pubmed/19682374
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21854596 |
| Contact name | Prof Aziz Sheikh |
| Address |
Professor of Primary Care Research & Development
Division of Community Health Sciences: GP Section University of Edinburgh 20 West Richmond Street |
| City/town | Edinburgh |
| Zip/Postcode | EH8 9DX |
| Country | United Kingdom |
| Aziz.sheikh@ed.ac.uk | |
| Sponsor | University of Edinburgh (UK) |
| Address |
College of Medicine and Veterinary Medicine Office
The Queen's Medical Research Institute 47 Little France Crescent |
| City/town | Edinburgh |
| Zip/Postcode | EH16 4TJ |
| Country | United Kingdom |
| paulmcg@miscorp.ed.ac.uk | |
| Date applied | 08/06/2006 |
| Last edited | 22/11/2011 |
| Date ISRCTN assigned | 11/09/2006 |
|
|
|
|
|
| © 2012 ISRCTN unless otherwise stated. | |
|
|
|
|