Condition category
Respiratory
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
01/11/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr M Innes

ORCID ID

Contact details

Stirchley Medical Practice
Sandino Road
Stirchley
Telford
TF3 1FB
United Kingdom
+44 (0)1952 660444

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0375126454

Study information

Scientific title

Acronym

Study hypothesis

Does knowledge of an abnormal spirometry result significantly improve smoke stop rates for smokers aged 35-75?

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

Not specified

Trial type

Not Specified

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/06/2002

Overall trial end date

01/06/2004

Reason abandoned

Lack of funding

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

1. Eg breathlessness
2. Terminally ill
3. Subjects with prior knowledge of spirometry status

Recruitment start date

01/06/2002

Recruitment end date

01/06/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Stirchley Medical Practice
Telford
TF3 1FB
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

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

Funders

Funder type

Government

Funder name

Shrewsbury and Telford Research and Development Consortium (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

Publication citations

Additional files

Editorial Notes