- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00962455
Feedback Reports and e-Learning in Primary Care Spirometry (FRESCO)
August 19, 2009 updated by: Radboud University Medical Center
Feedback Reports and E-learning to Support Spirometry Test Performance in Dutch Family Practices
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1135
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Nijmegen, Netherlands, 6500 HB
- Radboud University Nijmegen Medical Centre, Department of Primary and Community Care
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: e-learning & performance feedback
Initial e-learning by studying CD-Rom 'Spirometry Fundamentals', followed by repeated periodic performance feedback on spirometry test quality
|
Initial e-learning by studying CD-Rom 'Spirometry Fundamentals', followed by repeated periodic performance feedback on spirometry test quality
|
Active Comparator: Usual practice
Usual practice regarding spirometry execution in family practice
|
Usual practice regarding spirometry execution in family practice
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of spirometry tests with ≥2 acceptable blows according to 2005 ERS/ATS criteria that were also repeatable for both FEV1 and FVC
Time Frame: 12 months prospective follow-up
|
12 months prospective follow-up
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportions of tests with ≥2 acceptable blows according to 2005 ERS/ATS criteria
Time Frame: 12 months prospective follow-up
|
12 months prospective follow-up
|
Proportions of spirometry tests with ≥2 blows meeting 2005 ERS/ATS end-of-test criteria
Time Frame: 12 months prospective follow-up
|
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)
Time Frame: 12 months prospective follow-up
|
12 months prospective follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: 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
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2007
Primary Completion (Actual)
November 1, 2008
Study Completion (Actual)
April 1, 2009
Study Registration Dates
First Submitted
August 17, 2009
First Submitted That Met QC Criteria
August 19, 2009
First Posted (Estimate)
August 20, 2009
Study Record Updates
Last Update Posted (Estimate)
August 20, 2009
Last Update Submitted That Met QC Criteria
August 19, 2009
Last Verified
August 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UMCN-CARA-0001113
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Respiratory Tract Diseases
-
University of Colorado, DenverBiofireCompletedAcute Respiratory Infection | Lower Respiratory Tract Illness | Respiratory Pathogens | Upper Respiratory Tract IllnessUnited States
-
Vakzine Projekt Management GmbHFGK Clinical Research GmbHUnknownInfection, Respiratory TractGermany
-
Zambon SpACompleted
-
PfizerCompletedRespiratory Tract InfectionUnited States, Netherlands, Spain, Korea, Republic of, Denmark, Taiwan, Australia, Mexico, Canada, Japan, Finland, Argentina, Brazil, Chile, Gambia, New Zealand, Philippines, South Africa
-
GlaxoSmithKlineCompletedInfections, Respiratory TractUnited States
-
Direction Centrale du Service de Santé des ArméesRecruitingRespiratory Tract Infections | Respiratory Tract DiseaseFrance
-
PfizerCompletedRespiratory Tract InfectionUnited States, New Zealand, Chile, Argentina, South Africa
-
GlaxoSmithKlineCompletedInfections, Respiratory TractUnited States
-
AbbottEilafCompletedRespiratory Tract InfectionEgypt, Saudi Arabia
-
University of MontanaNational Institute of Environmental Health Sciences (NIEHS)CompletedLower Tract Respiratory InfectionUnited States
Clinical Trials on e-learning & performance feedback
-
MGH Institute of Health ProfessionsRecruitingDevelopmental Language DisorderUnited States
-
Kai Lutz, PhDUniversity of ZurichCompletedMotor Learning | Motor PerformanceSwitzerland
-
Cereneo AGCompleted
-
Antoine FourréUniversiteit Antwerpen; University of Mons; University of Picardie Jules VerneCompletedLow Back Pain | Physical Therapy | Knowledge, Attitudes, Practice | PhysiciansBelgium
-
University of Southern CaliforniaUniversity of California, Los Angeles; National Institute on Aging (NIA); University... and other collaboratorsWithdrawnEmergency DepartmentUnited States
-
University of DundeeUniversity of Strathclyde; Chief Scientist Office of the Scottish Government; Information Services Division, NHS ScotlandCompletedComplications of Surgical and Medical Care: General TermsUnited Kingdom
-
University GhentCompletedVascular DiseaseBelgium
-
British Urology Researchers in Surgical TrainingUniversity College, London; Photocure; University of Aberdeen; KARL STORZ Endoscopy-America... and other collaboratorsCompleted
-
Kessler FoundationNational Institute of Neurological Disorders and Stroke (NINDS); Moss Rehabilitation...RecruitingTraumatic Brain Injury | Major Depressive DisorderUnited States
-
Vilnius UniversityEnrolling by invitationFood Allergy in Children | Food Allergy in InfantsLithuania