Promoting smoking cessation in Bangladeshi and Pakistani male adults: pilot randomised controlled trial
| ISRCTN | ISRCTN82127540 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN82127540 |
| Protocol serial number | G0501288 |
| Sponsor | University of Edinburgh (UK) |
| Funder | National Prevention Research Initiative (NPRI) (UK) (ref: 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 of protocol
Not provided at time of registration
Contact information
Prof Aziz Sheikh
Scientific
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
| Aziz.sheikh@ed.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Pilot randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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). |
| Health condition(s) or problem(s) studied | 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(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. |
| Key secondary outcome measure(s) |
Added as of 02/07/2007: |
| Completion date | 28/02/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Male |
| Target sample size at registration | 180 |
| Key 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 |
| Key exclusion criteria | Those unwilling or unable to give informed consent will be excluded. |
| Date of first enrolment | 01/03/2006 |
| Date of final enrolment | 28/02/2008 |
Locations
Countries of recruitment
- United Kingdom
- Scotland
Study participating centre
Professor of Primary Care Research & Development
Edinburgh
EH8 9DX
United Kingdom
EH8 9DX
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 19/08/2011 | Yes | No | |
| Protocol article | protocol | 14/08/2009 | Yes | No |
