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 |
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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
Scientific
Stirchley Medical Practice
Sandino Road
Stirchley
Telford
TF3 1FB
United Kingdom
Phone | +44 (0)1952 660444 |
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Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Not Specified |
Scientific title | |
Study objectives | Does 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) studied | Respiratory: Chronic obstructive pulmonary disease (COPD) |
Intervention | Subjects 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 type | Other |
Primary outcome measure | Not provided at time of registration |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 01/06/2002 |
Completion date | 01/06/2004 |
Reason abandoned (if study stopped) | Lack of funding |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Not Specified |
Target number of participants | Not provided at time of registration |
Key inclusion criteria | All 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 criteria | 1. Eg breathlessness 2. Terminally ill 3. Subjects with prior knowledge of spirometry status |
Date of first enrolment | 01/06/2002 |
Date of final enrolment | 01/06/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Stirchley Medical Practice
Telford
TF3 1FB
United Kingdom
TF3 1FB
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Website | http://www.dh.gov.uk/Home/fs/en |
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Funders
Funder type
Government
Shrewsbury and Telford Research and Development Consortium (UK)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |