Respiratory Tract DiseasesPhase 4FRESCONCT00962455
Feedback Reports and e-Learning in Primary Care Spirometry
A Phase 4 study testing e-learning & performance feedback and usual practice in people with Respiratory Tract Diseases and Pulmonary Disease, Chronic Obstructive, run by Radboud University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Respiratory Tract Diseases, Pulmonary Disease, Chronic Obstructive, Asthma
- What is being tested?
- e-learning & performance feedback and usual practice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,135 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2007to Apr 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- age < 10 years
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud University Nijmegen Medical Centre, Department of Primary and Community Care
Nijmegen, 6500 HB
About this study
Official title: 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.
- Being tested
- e-learning & performance feedback, usual practice
- Keywords
- Spirometry, Family Practice, Randomized Controlled Trial, Feedback, Intervention Studies
- Medical subject headings
- Respiratory Tract Diseases, Pulmonary Disease, Chronic Obstructive, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
e-learning & performance feedbackOther
Initial e-learning by studying CD-Rom 'Spirometry Fundamentals', followed by repeated periodic performance feedback on spirometry test quality
usual practiceOther
Usual practice regarding spirometry execution in family practice
| Study group | Role | What they receive |
|---|---|---|
| e-learning & performance feedback | Experimental | Initial e-learning by studying CD-Rom 'Spirometry Fundamentals', followed by repeated periodic performance feedback on spirometry test quality Receives: Other: e-learning & performance feedback |
| Usual practice | Active comparator | Usual practice regarding spirometry execution in family practice Receives: Other: usual practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of spirometry tests with ≥2 acceptable blows according to 2005 ERS/ATS criteria that were also repeatable for both FEV1 and FVC
Measured: 12 months prospective follow-up
Secondary outcomes (3)
Proportions of tests with ≥2 acceptable blows according to 2005 ERS/ATS criteria
Measured: 12 months prospective follow-up
Proportions of spirometry tests with ≥2 blows meeting 2005 ERS/ATS end-of-test criteria
Measured: 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)
Measured: 12 months prospective follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2009 (estimated)
- Study startNov 2007
- Primary completionNov 2008
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Tract DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Quartz Transmural Centre for the Helmond Region, Elkerliek Hospital
- Investigators
- Tjard R Schermer, PhD, Principal investigator, Radboud University Medical CenterAlan J Crockett, PhD, Principal investigator, The University of AdelaideWillem Pieters, MD, PhD, Principal investigator, Elkerliek Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00962455
- Sponsor's protocol ID
- UMCN-CARA-0001113
- Acronym
- FRESCO
- Status last verified
- Aug 2009
- First submitted
- 17 Aug 2009
- Last updated
- 20 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feedback Reports and E-learning to Support Spirometry Test Performance in Dutch Family Practices
- ClinicalTrials.gov ID
- NCT00962455
- Acronym / sponsor ID
- FRESCO / UMCN-CARA-0001113
- Keywords
- Spirometry, Family Practice, Randomized Controlled Trial, Feedback, Intervention Studies
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,135 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Quartz Transmural Centre for the Helmond Region, Elkerliek Hospital
- Study start
- Nov 2007
- Primary completion
- Nov 2008 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 20 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| e-learning & performance feedback | Experimental | Other: e-learning & performance feedbackInitial e-learning by studying CD-Rom 'Spirometry Fundamentals', followed by repeated periodic performance feedback on spirometry test quality |
| Usual practice | Active comparator | Other: usual practiceUsual practice regarding spirometry execution in family practice |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- age < 10 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| e-learning & performance feedbackInitial e-learning by studying CD-Rom 'Spirometry Fundamentals', followed by repeated periodic performance feedback on spirometry test quality | Other | e-learning & performance feedback |
| usual practiceUsual practice regarding spirometry execution in family practice | Other | Usual practice |
Primary outcome
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
3 secondary outcomes
Proportions of tests with ≥2 acceptable blows according to 2005 ERS/ATS criteria
Time frame: 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tjard R Schermer, PhD principal investigator
Radboud University Medical Center
Alan J Crockett, PhD principal investigator
The University of Adelaide
Willem Pieters, MD, PhD principal investigator
Elkerliek Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing e-learning & performance feedback and usual practice in people with Respiratory Tract Diseases and Pulmonary Disease, Chronic Obstructive, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2009.