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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00962455
Other study ID # UMCN-CARA-0001113
Secondary ID
Status Completed
Phase Phase 4
First received August 17, 2009
Last updated August 19, 2009
Start date November 2007
Est. completion date April 2009

Study information

Verified date August 2009
Source Radboud University
Contact n/a
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Interventional

Clinical Trial Summary

Spirometry is a biomedical test to measure lung function in subject who (may) have a chronic respiratory condition. Performing the test requires a certain level of training and experience from the health care professional who conducts the test, and sufficient cooperation of the patient. Although the test is widely used in primary care in many countries, the quality of the test performance seems limited and needs improvement in order to avoid false-positive and false-negative test interpretations. In this study, the researchers investigated whether a combination of e-learning and bimonthly written performance feedback to family practice nurses and assistance regarding their spirometry tests improves the rate of adequate tests.


Recruitment information / eligibility

Status Completed
Enrollment 1135
Est. completion date April 2009
Est. primary completion date November 2008
Accepts healthy volunteers No
Gender Both
Age group 10 Years and older
Eligibility Inclusion Criteria for Family Practices:

- collaboration with Elkerliek Hospital Helmond through regional integrated care support service ('QUARTZ')

- purchased spirometer through this support service

- have implemented spirometry as a part of routine patient care

Inclusion Criteria for Patients:

- registered in one of the participating family practices

- performed a spirometry test as a part of routine care during the observation period of the study

Exclusion Criteria for Patients:

- age < 10 years

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)


Related Conditions & MeSH terms


Intervention

Other:
e-learning & performance feedback
Initial e-learning by studying CD-Rom 'Spirometry Fundamentals', followed by repeated periodic performance feedback on spirometry test quality
usual practice
Usual practice regarding spirometry execution in family practice

Locations

Country Name City State
Netherlands Radboud University Nijmegen Medical Centre, Department of Primary and Community Care Nijmegen

Sponsors (3)

Lead Sponsor Collaborator
Radboud University Elkerliek Hospital, Quartz Transmural Centre for the Helmond Region

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of spirometry tests with =2 acceptable blows according to 2005 ERS/ATS criteria that were also repeatable for both FEV1 and FVC 12 months prospective follow-up No
Secondary Proportions of tests with =2 acceptable blows according to 2005 ERS/ATS criteria 12 months prospective follow-up No
Secondary Proportions of spirometry tests with =2 blows meeting 2005 ERS/ATS end-of-test criteria 12 months prospective follow-up No
Secondary Proportions of spirometry tests with A to C grade according to scholastic-type quality grading system by Ferguson et al (2000) 12 months prospective follow-up No
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