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.
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 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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
1. 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29536597