Contact information
Type
Scientific
Primary contact
Prof Peter Hajek
ORCID ID
Contact details
Psychology Section
Department of Human Science
St. Bartholomew's and the Royal London School of Medicine
Turner Street
London
E1 2AD
United Kingdom
+44 (0)20 7377 7345
P.Hajek@mds.qmw.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HB115
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/1996
Overall trial end date
01/04/2000
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
540
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
01/01/1996
Recruitment end date
01/04/2000
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Psychology Section
London
E1 2AD
United Kingdom
Sponsor information
Organisation
Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Cardiovascular Disease and Stroke National Research and Development Programme (UK)
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
2002 results in http://www.ncbi.nlm.nih.gov/pubmed/11786452
Publication citations
-
Results
Hajek P, Taylor TZ, Mills P, Brief intervention during hospital admission to help patients to give up smoking after myocardial infarction and bypass surgery: randomised controlled trial., BMJ, 2002, 324, 7329, 87-89.