Condition category
Mental and Behavioural Disorders
Date applied
29/09/2010
Date assigned
19/10/2010
Last edited
05/02/2016
Prospective/Retrospective
Prospectively 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

Dr Taina Taskila

ORCID ID

Contact details

Primary Care Clinical Sciences
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom

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

Sponsor information

Organisation

University of Birmingham

Sponsor details

c/o Dr Brendan Laverty
Edgbaston
Birmingham
B15 2TT
United Kingdom

Sponsor type

University/education

Website

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

Publication citations

Additional files

Editorial Notes

05/02/2016: No publications found, verifying study status with principal investigator