NCT00962455

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,135

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 20, 2009

Completed
Last Updated

August 20, 2009

Status Verified

August 1, 2009

Enrollment Period

1 year

First QC Date

August 17, 2009

Last Update Submit

August 19, 2009

Conditions

Keywords

SpirometryFamily PracticeRandomized Controlled TrialFeedbackIntervention Studies

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Proportions of tests with ≥2 acceptable blows according to 2005 ERS/ATS criteria

    12 months prospective follow-up

  • Proportions of spirometry tests with ≥2 blows meeting 2005 ERS/ATS end-of-test criteria

    12 months prospective follow-up

  • 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

Study Arms (2)

e-learning & performance feedback

EXPERIMENTAL

Initial e-learning by studying CD-Rom 'Spirometry Fundamentals', followed by repeated periodic performance feedback on spirometry test quality

Other: e-learning & performance feedback

Usual practice

ACTIVE COMPARATOR

Usual practice regarding spirometry execution in family practice

Other: usual practice

Interventions

Initial e-learning by studying CD-Rom 'Spirometry Fundamentals', followed by repeated periodic performance feedback on spirometry test quality

e-learning & performance feedback

Usual practice regarding spirometry execution in family practice

Usual practice

Eligibility Criteria

Age10 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • age \< 10 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University Nijmegen Medical Centre, Department of Primary and Community Care

Nijmegen, 6500 HB, Netherlands

Location

MeSH Terms

Conditions

Respiratory Tract DiseasesPulmonary Disease, Chronic ObstructiveAsthma

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBronchial DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Tjard R Schermer, PhD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR
  • Alan J Crockett, PhD

    The University of Adelaide

    PRINCIPAL INVESTIGATOR
  • Willem Pieters, MD, PhD

    Elkerliek Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 17, 2009

First Posted

August 20, 2009

Study Start

November 1, 2007

Primary Completion

November 1, 2008

Study Completion

April 1, 2009

Last Updated

August 20, 2009

Record last verified: 2009-08

Locations