Condition category
Circulatory System
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
17/09/2010
Prospective/Retrospective
Retrospectively 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

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

http://www.doh.gov.uk

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

  1. 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.

Additional files

Editorial Notes