SpirometryNCT02005952
Effectiveness of Two Methods for Quality Control in Primary Care Spirometry
An observational study of Spirometry, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
Trial summary
Still not well resolved access, execution and interpretation of spirometry in primary care medicine. This seriously affects the quality of care of chronic respiratory diseases. OBJECTIVE: To compare the effectiveness of two methods for quality control in performing spirometry in primary care teams (EAP) participating… Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Spirometry
- How many people
- 3,000 participants
- Where
- No sites listed yet
- Study dates
- Feb 2010to Jun 2012
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients requiring spirometry performing a diagnostic or tracking control for respiratory disease
Who may be able to join
- All patients seen in the participating primary care, requiring spirometry for both the diagnosis and control of any disease will be included.
Who cannot join
- Patients under 15 years
About this study
Still not well resolved access, execution and interpretation of spirometry in primary care medicine. This seriously affects the quality of care of chronic respiratory diseases.
OBJECTIVE: To compare the effectiveness of two methods for quality control in performing spirometry in primary care teams (EAP) participating in the "Healthcare Process Chronic Obstructive Pulmonary Disease (COPD )" (multidisciplinary program between primary care medicine and hospital for improved care COPD).
Read more
METHODS: Randomized controlled trial of clusters of EAP participants ( n = 17 ). The quality control of spirometry in each EAP randomize into three branches:
- Supervision from the pulmonary function laboratory of the Hospital ; computer.
- Program incorporated into automated spirometer.
- Spirometric usual practice (control group without any support on the quality ). Spirometry EAP participants include year follow-up study . All sites use the same model spirometer and have received the same previous training . In a 2nd phase results implementing the most effective method shown in the 1st phase was studied.
EXPECTED RESULTS : The method for quality control more effective to obtain and maintain the quality spirometry.
POTENTIAL IMPACT EXPECTED : performing spirometry quality in the EAP , improve early detection (secondary prevention ) , the diagnosis of the severity and developmental control of COPD.
- Conditions
- Spirometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Spirometry, quality control, Pulmonary Function Laboratory | Performing spirometry, with control over the quality of the same, made from the pulmonary function laboratory of the Hospital de la Santa Creu i Sant Pau. | |
| Spirometry, quality control, software | Performing spirometry, with the support of software self-management quality of spirometry maneuvers incorporated therein | |
| Spirometry, quality control, control group | Performing spirometry in the way that is currently working in primary care (control group without any support). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of two methods for quality control in primary care spirometry
Measured: Basal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2013 (estimated)
- Study startFeb 2010
- Primary completionMar 2011
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpirometryStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jordi Giner, MSc, Principal investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02005952
- Sponsor's protocol ID
- 09/078/992
- Status last verified
- May 2009
- First submitted
- 26 Nov 2013
- Last updated
- 9 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Two Methods for Quality Control in Primary Care Spirometry
- ClinicalTrials.gov ID
- NCT02005952
- Acronym / sponsor ID
- 09/078/992
- Conditions
- Spirometry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 9 Dec 2013 (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.
Still not well resolved access, execution and interpretation of spirometry in primary care medicine. This seriously affects the quality of care of chronic respiratory diseases.
OBJECTIVE: To compare the effectiveness of two methods for quality control in performing spirometry in primary care teams (EAP) participating in the "Healthcare Process Chronic Obstructive Pulmonary Disease (COPD )" (multidisciplinary program between primary care medicine and hospital for improved care COPD).
METHODS: Randomized controlled trial of clusters of EAP participants ( n = 17 ). The quality control of spirometry in each EAP randomize into three branches:
- Supervision from the pulmonary function laboratory of the Hospital ; computer.
- Program incorporated into automated spirometer.
- Spirometric usual practice (control group without any support on the quality ). Spirometry EAP participants include year follow-up study . All sites use the same model spirometer and have received the same previous training . In a 2nd phase results implementing the most effective method shown in the 1st phase was studied.
EXPECTED RESULTS : The method for quality control more effective to obtain and maintain the quality spirometry.
POTENTIAL IMPACT EXPECTED : performing spirometry quality in the EAP , improve early detection (secondary prevention ) , the diagnosis of the severity and developmental control of COPD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Spirometry, quality control, Pulmonary Function Laboratory | – | –Performing spirometry, with control over the quality of the same, made from the pulmonary function laboratory of the Hospital de la Santa Creu i Sant Pau. |
| Spirometry, quality control, software | – | –Performing spirometry, with the support of software self-management quality of spirometry maneuvers incorporated therein |
| Spirometry, quality control, control group | – | –Performing spirometry in the way that is currently working in primary care (control group without any support). |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients requiring spirometry performing a diagnostic or tracking control for respiratory disease
Key inclusion criteria (1 listed)
- All patients seen in the participating primary care, requiring spirometry for both the diagnosis and control of any disease will be included.
Key exclusion criteria (1 listed)
- Patients under 15 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Effectiveness of two methods for quality control in primary care spirometry
Time frame: Basal
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 9 Dec 2013.
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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.
Jordi Giner, MSc principal investigator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Questions about this trial
What is this clinical trial studying?
An observational study of Spirometry, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
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 1 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 9 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Effectiveness of two methods for quality control in primary care spirometry (time frame: Basal). 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 9 Dec 2013.