A brief intervention to prevent smoking relapse in cardiac patients: a randomised controlled trial

ISRCTN	ISRCTN13036545
DOI	https://doi.org/10.1186/ISRCTN13036545
Protocol serial number	HB115
Sponsor	Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Funder	NHS Cardiovascular Disease and Stroke National Research and Development Programme (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Peter Hajek
Scientific

Psychology Section
Department of Human Science
St. Bartholomew's and the Royal London School of Medicine
Turner Street
London
E1 2AD
United Kingdom

Phone	+44 (0)20 7377 7345
Email	P.Hajek@mds.qmw.ac.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	This was a randomised controlled trial of a routinely deliverable, relapse-prevention intervention with cardiac in-patients who smoked prior to hospital admission. The question was whether a brief intervention designed to be implemented as a part of routine care on a national basis is feasible and powerful enough to make an impact on this hard-to-reach group in terms of continuous long-term biochemically validated abstinence.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Cardiovascular diseases: Heart disease
Intervention	1. Multimodal intervention included, in addition to the personal advice, a relapse prevention booklet, quiz about its contents, an offer to join a 'buddy' support system, signing a declaration of commitment not to smoke, and carbon monoxide monitoring. 2. Usual care
Intervention type	Other
Primary outcome measure(s)	Continuous abstinence for 6 weeks and 12 months, biochemically validated by expired air CO. The delivery of the various parts of the intervention was monitored.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/04/2000

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	540
Key inclusion criteria	1. 540 smokers hospitalised after myocardial infarction or cardiac bypass surgery 2. Current smokers or recent ex-smokers (defined as stopping smoking up to six months earlier) at the time of their hospital admission 3. Had not smoked at all since their hospital admission 4. Sufficiently recovered to receive the intervention, 5. No gross memory impairment 6. Under 76 years of age 7. Could read English 8. Motivated to remain abstinent from smoking after their discharge from the hospital
Key exclusion criteria	Does not match inclusion criteria
Date of first enrolment	01/01/1996
Date of final enrolment	01/04/2000

Psychology Section

London
E1 2AD
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	12/01/2002		Yes	No