Determining the optimal approach to identifying individuals with chronic obstructive pulmonary disease
| ISRCTN | ISRCTN42132522 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN42132522 |
| Secondary identifying numbers | N/A |
- Submission date
- 22/02/2011
- Registration date
- 31/03/2011
- Last edited
- 19/11/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mrs Lisa Dyson
Scientific
Scientific
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 |
Study information
| Study design | Multi-centre randomised trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Determining the optimal approach to identifying individuals with chronic obstructive pulmonary disease: a multi-centre randomised trial |
| Study acronym | DOC study |
| Study objectives | 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(s) | Newcastle and North Tyneside 2 Research Ethics Committee, 29/07/2010, ref: 10/H0907/37 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/05/2011 |
| Completion date | 01/09/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 600 |
| Key inclusion criteria | Current smokers aged 35 years or more who are registered with participating GP practices |
| Key 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 |
| Date of first enrolment | 01/05/2011 |
| Date of final enrolment | 31/07/2012 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
York Trials Unit
York
YO10 5DD
United Kingdom
YO10 5DD
United Kingdom
Sponsor information
University of York (UK)
University/education
University/education
c/o Sue Final
Innovation Centre
York
YO10 5DD
England
United Kingdom
| sue.final@york.ac.uk | |
| Website | http://www.york.ac.uk/ |
"ROR" |
https://ror.org/04m01e293 |
Funders
Funder type
Government
Department of Health (UK) - Respiratory Programme
No information available
Results and Publications
| Intention to publish date | 31/12/2015 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | The results are expected to be published in 2015 |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2018 | Yes | No |
Editorial Notes
19/11/2018: Publication reference added.
15/11/2017: No publications found, verifying study status with principal investigator.
16/06/2015: The overall trial end date was changed from 31/07/2012 to 01/09/2013.
