An evaluation of the cost effectiveness of single test screening spirometry in the early diagnosis and management of Chronic Obstructive Pulmonary Disease (COPD) in primary care

ISRCTN ISRCTN72258018
DOI https://doi.org/10.1186/ISRCTN72258018
Secondary identifying numbers N0375126454
Submission date
30/09/2004
Registration date
30/09/2004
Last edited
01/11/2011
Recruitment status
Stopped
Overall study status
Stopped
Condition category
Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr M Innes
Scientific

Stirchley Medical Practice
Sandino Road
Stirchley
Telford
TF3 1FB
United Kingdom

Phone +44 (0)1952 660444

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study objectivesDoes knowledge of an abnormal spirometry result significantly improve smoke stop rates for smokers aged 35-75?
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedRespiratory: Chronic obstructive pulmonary disease (COPD)
InterventionSubjects will be recruited opportunistically in primary care. On average each practice is expected to recruit between 80-90 individuals. Subjects who accept will then be randomised to receive or not receive spirometry at the start of the HTQ programme. Both groups will be assessed on generic quality of life (QoL) and anxiety. Practice nurses will be trained and administer all questionnaires and tests, for which they will receive a payment. At 12 months subjects in both groups will be reviewed and receive spirometry and repeat QoL and anxiety questionnaires.

Please note, this trial was stopped due to lack of funding.
Intervention typeOther
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/06/2002
Completion date01/06/2004
Reason abandoned (if study stopped)Lack of funding

Eligibility

Participant type(s)Patient
Age groupAdult
SexNot Specified
Target number of participantsNot provided at time of registration
Key inclusion criteriaAll smokers with 20 pack years plus, aged between 35 and 75, presenting in primary care to the HTQ Programme will be eligible for entry into the trial. All subjects recruited to the HTQ programme who fulfill the eligibility criteria will be invited to take part in the study.
Key exclusion criteria1. Eg breathlessness
2. Terminally ill
3. Subjects with prior knowledge of spirometry status
Date of first enrolment01/06/2002
Date of final enrolment01/06/2004

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Stirchley Medical Practice
Telford
TF3 1FB
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Shrewsbury and Telford Research and Development Consortium (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan