Efficacy of "On Line" Telematic Spirometry

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Juan F. Masa, Sociedad Española de Neumología y Cirugía Torácica
ClinicalTrials.gov Identifier:
NCT00844116
First received: February 12, 2009
Last updated: May 15, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention
Chronic Obstructive Pulmonary Disease
Device: spirometry

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Efficacy of "On Line" Telematic Spirometry

Further study details as provided by Sociedad Española de Neumología y Cirugía Torácica:

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 [ Time Frame: at the end of the study ] [ Designated as safety issue: No ]

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 [ Time Frame: at the end of the study ] [ Designated as safety issue: No ]

Enrollment: 226
Study Start Date: January 2009
Study Completion Date: December 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Conventional Spirometry
personal spirometry
Device: spirometry
Conventional and telematic spirometry
Experimental: Telematic Spirometry
performed remotely "on line"
Device: spirometry
Conventional and telematic spirometry

  Eligibility

Ages Eligible for Study:   14 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00844116

Locations
Spain
Hospital San Pedro de Alcántara. Servicio Extremeño de Salud
Cáceres, Spain, 10003
Sponsors and Collaborators
Sociedad Española de Neumología y Cirugía Torácica
Investigators
Principal Investigator: Juan F. Masa, M.D Hospital San Pedro de Alcántara. Cáceres. Spain
  More Information

No publications provided

Responsible Party: Juan F. Masa, MD, Sociedad Española de Neumología y Cirugía Torácica
ClinicalTrials.gov Identifier: NCT00844116     History of Changes
Other Study ID Numbers: PI040727
Study First Received: February 12, 2009
Last Updated: May 15, 2012
Health Authority: Spain: Ministry of Health and Consumption

Keywords provided by Sociedad Española de Neumología y Cirugía Torácica:
COPD
spirometry
Telematic spirometry

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 01, 2014