|- candidate number||12158|
|- NTR Number||NTR3391|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||30-mrt-2012|
|- Secondary IDs||12N36 METC Heerlen, The Netherlands|
|- Public Title||Assessment of the COPD risktest in the general practice.|
|- Scientific Title||Implementation of the COPD risktest in general practice.|
|- hypothesis||There is underdiagnosis of COPD. To solve this problem, we want to check healthy persons after a questionnaire on high risk of COPD. |
|- Healt Condition(s) or Problem(s) studied||Risc, Chronic Obstructive Pulmonary Disease (COPD), Questionnaires, General practitioner, Underdiagnosis|
|- Inclusion criteria||All healthy persons from 40 till 70 years old.|
|- Exclusion criteria||All persons having COPD or astma or bronchitis or immobile or having a terminal disease like cancer, or having severe comorbidities.|
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||16-apr-2012|
|- planned closingdate||9-jul-2012|
|- Target number of participants||10|
|- Interventions||The intervention in this survey is to implement early detection of COPD as a structural inbedded method in daily general practice work. The COPD risktest as a health questionnaire will be used and send to all patients of one age cohort year (between 40 and 70 years) in a month. After response workload and time aspects will be assessed. There will be used questionnaires for health workers: the Barrier and Facilitator Assessment Instrument; in-depth interviews; time capacity checklist; practice characteristics. |
|- Primary outcome||1. Inventarisation of workload in general practice during implementation of the COPD risktest;|
2. To detect the barriers and beneficial factors during implementation;
3. To help to construct and enroll a national guideline for implementation of the COPD risktest.
|- Secondary outcome||1. To detect differences between lower and higher social class respondents;|
2. Measuring attitudes and opinions of the health workers in a general practice.
|- Timepoints||Preparation of the study: January,February, March 2012.|
Data collection: April,May and June 2012.
Working out and writing and making conclusions in a report: July and August 2012.
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||MD. PhD. Jean Muris|
|- CONTACT for SCIENTIFIC QUERIES|| H. Tange|
|- Sponsor/Initiator ||Astmafonds Foundation|
(Source(s) of Monetary or Material Support)
|CAPHRI, The Research Institute of the University Maastricht |
|- Publications||1.Dirven JAM, Muris JWM, Schayck CP van. COPD Screening in General Practice Using a Telephone Questionnaire. Journal of Chronic Obstructive Pulmonary Disease, 2010, 7:352–359. |
2.Van Schayck CP, Loozen JM, Wagena E et al. Detecting patients at a high risk of developing chronic obstructive pulmonary disease in general practice: cross sectional case finding study. BMJ 2002; 324: 1370.
3.Price DB, Tinkelman DG, Halbert RJ et al. Symptom-based questionnaire for identifying COPD in smokers. Respiration 2006; 73: 285-295.
|- Brief summary||Rationale:|
In the general practice there is COPD underdiagnosis. Early detection of COPD can delay the pathological process of the disease. We know the COPD Respiratory Screening Health Questionnaire as validated risktest to find COPD patients at risk. The Dutch Association of General Practitioners is going to develop a program for GP’s to launch the pilot of the “COPD Prevention Consultation Program”, where the COPD risktest is used. This research protocol includes an assessment of this program.
How will the “COPD prevention consultation program” influence the workload in a general practice? Which barriers will be met?
An observational survey among health care workers using mixed methods.
(quantitative questionnaires and in-depth interviews).
All health care workers who are involved in the “COPD Prevention Consultation Program” in the general practice surgery.
Main study parameters/endpoints:
The expirienced workload for health care workers. Barriers and beneficial factors.
|- Main changes (audit trail)|
|- RECORD||30-mrt-2012 - 21-apr-2012|