Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Version 1
Study information
Scientific title
A randomised controlled trial testing the feasibility of nicotine assisted reduction to stop in General Practice
Acronym
RedGP
Study hypothesis
1. General Practices can successfully implement smoking reduction programme as part of their stop smoking service
2. Reducing smoking gradually will help people with chronic conditions to stop smoking
Ethics approval
West Midlands REC Centre, ref: 10/H1208/67
Study design
2-arm cluster randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet
Condition
Smoking reduction
Intervention
Participants will be randomised into either an intervention group receiving a smoking reduction service or a control group receiving the standard NHS care.
Participants in the intervention group will be encouraged to use both a nicotine patch and a short acting form of NRT. Patients who agree to behavioural support, will be in the trial for a minimum of 2 weeks and maximum of 20 weeks.
The programme will be evaluated using qualitative methods. Semi structured interviews with a sample of GPs and their medical staff as well as trial participants.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. Number of people within the populations of interest that are offered smoking reduction programmes
2. Number that take up the offer
3. Number of behavioural support visits made
4. Amount of NRT used
5. Number that complete reduction programmes
6. All episodes where a GP records that a patient stopped NRT due to adverse events
Secondary outcome measures
1. Number of people within the population of interest that try to quit smoking
2. Number that succeed in quitting: Success defined as a self-report of at least four weeks of complete cessation verified by at least one CO reading of <10ppm, which is in line with the NHS standard
3. Proportion of people that meet the GCP criteria for serious adverse events and the occurrence of any events of interest e.g. hospitalisation for acute coronary syndrome in those with ischaemic heart disease. These are events where smoking cessation might be expected to reduce the incidence.
4. All hospitalisations and visits to the GP, classifying the latter as scheduled for chronic care and incidental events
5. Number of people that reduce their smoking: Smoking reduction defined as smoking <50% of baseline cigarettes per day accompanied by a fall of at least 1ppm in exhaled carbon monoxide
Overall trial start date
01/12/2010
Overall trial end date
30/06/2013
Reason abandoned
Eligibility
Participant inclusion criteria
1. Males and females 18 years or older
2. People with one or more of the following chronic conditions:
2.1. Ischaemic heart disease
2.2. Hypertension
2.3. Diabetes mellitus
2.4. Stroke
2.5. Asthma
2.6. Chronic Obstructive Pulmonary Disease (COPD)
2.7. Chronic kidney disease
2.8. Schizophrenia
2.9. Bipolar disorder
3. For the intervention arms only: Daily smokers with either a carbon monoxide (CO) of at least 10 parts per million (ppm) at least 15 minutes after last smoking or smoke at least 10 cigarettes or 8g of loose tobacco as roll your own cigarettes daily
4. As the programme will be offered as a part of normal follow-up care, consent will not be required.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
400
Participant exclusion criteria
Does not match inclusion criteria.
All smokers, regardless of interest are included in the denominator population. Some smokers might not be offered NRT if, in the judgement of their GP, it would be unsafe to do so. The situations where this might occur include:
1. Has had severe reactions to NRT previously
2. Unstable angina pectoris, myocardial infarction, acute coronary syndrome, or cerebrovascular accident during the last 3 weeks
3. Severe cardiac arrhythmia
4. Currently uncontrolled hyperthyroidism
5. Active phaeocromocytoma
6. Pregnancy or lactation
Recruitment start date
01/12/2010
Recruitment end date
30/06/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Primary Care Clinical Sciences
Birmingham
B15 2TT
United Kingdom
Funders
Funder type
Hospital/treatment centre
Funder name
Heart of Birmingham Teaching Primary Care Trust (UK) - (REF: 114000391)
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