Efficacy of "On Line" Telematic Spirometry
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
spirometry
Sponsored by
About this trial
This is an interventional health services research trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, spirometry, Telematic spirometry
Eligibility Criteria
Inclusion Criteria:
- Age between 14 and 70 years.
- Patients referred for pulmonary consultation from primary care center.
Exclusion Criteria:
- Psychophysical incapacity to performed spirometry.
- Informed consent not obtained.
Sites / Locations
- Hospital San Pedro de Alcántara. Servicio Extremeño de Salud
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Conventional Spirometry
Telematic Spirometry
Arm Description
personal spirometry
performed remotely "on line"
Outcomes
Primary Outcome Measures
The spirometry performed "on line" with a technician in a remote place from the patient has the same efficacy as the one performed personally and FEV1 and FVC
Secondary Outcome Measures
Nº total test feasible Nº total of test Percentage of cases excluded(dropouts) for failure to obstain three acceptable and two reproducibles test
Full Information
NCT ID
NCT00844116
First Posted
February 12, 2009
Last Updated
May 15, 2012
Sponsor
Sociedad Española de Neumología y Cirugía Torácica
1. Study Identification
Unique Protocol Identification Number
NCT00844116
Brief Title
Efficacy of "On Line" Telematic Spirometry
Official Title
Efficacy of "On Line" Telematic Spirometry
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sociedad Española de Neumología y Cirugía Torácica
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators aim to demonstrate that spirometry performed "on line" with a technician in a remote place from the patient has the same efficacy as the one performed personally. As a previous study the investigators analyzed the inter-observer agreement between two pulmonary function technicians from both centers taking part in the study: San Pedro de Alcántara Hospital (Cáceres) and Carlos III hospital (Madrid). The main study will be broad (226 patients derivates from primary care to pneumology consultation), prospective, aleatorized, crossed, blind and controlled. The patients will be aleatorized in two groups: 1) personal spirometry: performed in a conventional way; 2) telematic spirometry: performed remotely "on line". The same pulmonary function technician, who will carry out the spirometries personally, will be located in a nearly room. The technician will control the computer office and the spirometer software in the patients's room with another computer. By means of teleconference, the technician will indicate the patient to start the maneuver. After 20 minutes from the end of the first spirometry, the patients will complete the protocol of the following group. The mean values of FVC, FEV1 and FEV1/FVC, the mean time of spirometry performance, the mean number of spirometric maneuvers performed, are compared between both groups by t proof for paired data. The comparison of the percentage of proofs with non acceptability or reproducibility criteria will be made by X2 test. The analysis will be made blindly. The inter-observer and intra-observer agreement will be evaluated by analysis of intraclass correlation for FVC and FEV1 values.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD, spirometry, Telematic spirometry
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
226 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional Spirometry
Arm Type
Active Comparator
Arm Description
personal spirometry
Arm Title
Telematic Spirometry
Arm Type
Experimental
Arm Description
performed remotely "on line"
Intervention Type
Device
Intervention Name(s)
spirometry
Intervention Description
Conventional and telematic spirometry
Primary Outcome Measure Information:
Title
The spirometry performed "on line" with a technician in a remote place from the patient has the same efficacy as the one performed personally and FEV1 and FVC
Time Frame
at the end of the study
Secondary Outcome Measure Information:
Title
Nº total test feasible Nº total of test Percentage of cases excluded(dropouts) for failure to obstain three acceptable and two reproducibles test
Time Frame
at the end of the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age between 14 and 70 years.
Patients referred for pulmonary consultation from primary care center.
Exclusion Criteria:
Psychophysical incapacity to performed spirometry.
Informed consent not obtained.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan F. Masa, M.D
Organizational Affiliation
Hospital San Pedro de Alcántara. Cáceres. Spain
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital San Pedro de Alcántara. Servicio Extremeño de Salud
City
Cáceres
ZIP/Postal Code
10003
Country
Spain
12. IPD Sharing Statement
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Efficacy of "On Line" Telematic Spirometry
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