Condition category
Respiratory
Date applied
22/02/2011
Date assigned
31/03/2011
Last edited
16/06/2015
Prospective/Retrospective
Prospectively 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

Mrs Lisa Dyson

ORCID ID

Contact details

York Trials Unit
Ground Floor ARRC Building
Department of Health Sciences
University of York
Heslington
York
YO10 5DD
United Kingdom
-
lisa.dyson@york.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Determining the optimal approach to identifying individuals with chronic obstructive pulmonary disease: a multi-centre randomised trial

Acronym

DOC study

Study hypothesis

1. To identify the most effective case-finding pathway for chronic obstructive pulmonary disease (COPD). The specific health service impacts across different possible pathways for undertaking COPD case finding amongst current smokers in primary care settings will be assessed.
2. To assess the cost-effectiveness of COPD case-finding pathways. A cost-per-true-positive-case-found analysis will be undertaken and health care resource use will be incorporated.
3. To evaluate the efficiency of the 'case finding' pathway. Key factors to consider will be the quality of the forced expiratory volume in one second (FEV1)/forced vital capacity (FVC), mechanical peak expiratory flow rate (PEFR) measurements and wheezometer measurements (in relation to the reference standard).
4. To evaluate whether undergoing the diagnostic test(s) has an impact on smoking behaviour to inform future smoking cessation studies.

On 16/06/2015 the overall trial end date was changed from 31/07/2012 to 01/09/2013.

Ethics approval

Newcastle and North Tyneside 2 Research Ethics Committee, 29/07/2010, ref: 10/H0907/37

Study design

Multi-centre randomised trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Chronic obstructive pulmonary disease (COPD)

Intervention

1. Participants will undertake lung function tests (i.e. peak flow measurement, microspirometry and post-bronchodilator spirometry), a wheeze-detecting device (i.e. wheezometer) and a case-finding questionnaire
2. Further questionnaires will be completed during the study; a screening questionnaire and a follow-up questionnaire.

All participants receive the case-finding tests, with half randomised to receive the tests straight away and the remainder will receive the tests approximately 6 months later.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Effectiveness of diagnostic pathways - aim to identify the most effective pathway for use as the routine service model in primary care

Secondary outcome measures

1. Cost-effectiveness of COPD case-finding pathway
2. Efficiency of COPD case-finding pathway
3. Impact on smoking behaviour

Overall trial start date

01/05/2011

Overall trial end date

01/09/2013

Reason abandoned

Eligibility

Participant inclusion criteria

Current smokers aged 35 years or more who are registered with participating GP practices

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

600

Participant exclusion criteria

1. Pregnancy
2. Recent history (within 8 weeks) of myocardial infarction, stroke, pulmonary embolism, chest/abdominal surgery or eye surgery
3. Any mental or physical condition (e.g. chest/ abdominal pain/ stress incontinence) or any other condition which means the participant is unable to undergo the case-finding tools

Recruitment start date

01/05/2011

Recruitment end date

31/07/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

York Trials Unit
York
YO10 5DD
United Kingdom

Sponsor information

Organisation

University of York (UK)

Sponsor details

c/o Sue Final
Innovation Centre
York
YO10 5DD
United Kingdom
-
sue.final@york.ac.uk

Sponsor type

University/education

Website

http://www.york.ac.uk/

Funders

Funder type

Government

Funder name

Department of Health (UK) - Respiratory Programme

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The results are expected to be published in 2015

Intention to publish date

31/12/2015

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes