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Tele-spirometry in Primary Care-Randomized Clinical Trial Cluster:Telemedicine in Chronic Obstructive Pulmonary Disease (RESPIRANET-C)

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ClinicalTrials.gov Identifier: NCT02901535
Recruitment Status : Unknown
Verified January 2017 by Hospital de Clinicas de Porto Alegre.
Recruitment status was:  Recruiting
First Posted : September 15, 2016
Last Update Posted : January 18, 2017
Sponsor:
Collaborators:
Federal University of Rio Grande do Sul
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Ministry of Health, Brazil
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre

Brief Summary:
The purpose of this study is to determine the effectiveness of telemedicine multifaceted intervention in symptoms patients with chronic obstructive pulmonary disease.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Other: Spirometry Other: telemonitoring Other: teleconsultation Other: Spirometry - 20 weeks Not Applicable

Detailed Description:
This study is a randomized clinical trial for patients with chronic obstructive pulmonary disease from a primary care. The purpose is to determine the effectiveness of telemedicine (teleconsultation and telemonitoring) in control of chronic obstructive pulmonary disease symptoms.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Tele-spirometry in Primary Care - Randomized Clinical Trial Cluster: the Effectiveness of Multifaceted Intervention in Symptoms Patients With Respiratory Illness
Study Start Date : April 2015
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
Active Comparator: Control
Spirometry in baseline Spirometry - 20 weeks
Other: Spirometry
Spirometry in baseline

Other: Spirometry - 20 weeks
Spirometry (20 weeks)

Experimental: Intervention
Spirometry in baseline Teleconsultation Telemonitoring Spirometry - 20 weeks
Other: Spirometry
Spirometry in baseline

Other: telemonitoring
telemonitoring (phone call nurse - 45 and 90 days)

Other: teleconsultation
teleconsultation (general practioner received phone call to respiratory care)

Other: Spirometry - 20 weeks
Spirometry (20 weeks)




Primary Outcome Measures :
  1. Symptoms [ Time Frame: 20 a 22 weeks ]
    Modified Medical Research Council Dyspnea Scale (difference in mMRC)


Secondary Outcome Measures :
  1. Spirometry - FEV1 [ Time Frame: 20 a 22 weeks ]
    spirometry parameters - FEV 1 (forced expiratory volume in one second)

  2. Spirometry - FVC [ Time Frame: 20 a 22 weeks ]
    spirometry parameters - FVC (forced vital capacity)



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • spirometry from TelessaudeRS-Universidade Federal do Rio Grande do Sul (from randomization cluster), Modified Medical Research Council Dyspnea > 0

Exclusion Criteria:

  • normal or restrictive spirometry, low quality spirometries (inadequate)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02901535


Contacts
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Contact: Marcelo R. Gonçalves, PhD 5191175156 ext +55 marcelorog@gmail.com
Contact: Cynthia G Molina-Bastos, MD 5191322585 ext +55 cyncarol@gmail.com

Locations
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Brazil
TelessaudeRS-Universidade Federal do Rio Grande do Sul Recruiting
Porto Alegre, Rio Grande do Sul, Brazil, 90670000
Contact: Cynthia G Molina-Bastos, MD    5191322585 ext +55    cyncarol@gmail.com   
Contact: Marcelo R. Gonçalves, PhD    5191175156 ext +55    marcelorog@gmail.com   
Sub-Investigator: Maria Angela F Moreira, PhD         
Sub-Investigator: Dimitris V Rados, Msc         
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Federal University of Rio Grande do Sul
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Ministry of Health, Brazil
Investigators
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Principal Investigator: Erno Harzheim, PhD Federal University of Rio Grande do Sul

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Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT02901535     History of Changes
Other Study ID Numbers: 227190 COPD
First Posted: September 15, 2016    Key Record Dates
Last Update Posted: January 18, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Hospital de Clinicas de Porto Alegre:
telemedicine
chronic obstructive pulmonary disease
Primary Health care
spirometry
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases