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Tele-spirometry in Primary Care - Randomized Clinical Trial Cluster: the Effectiveness of Telemedicine in Asthma (RESPIRANET-A)

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ClinicalTrials.gov Identifier: NCT02901522
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
Prefeitura Municipal de Porto Alegre
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 asthma.

Condition or disease Intervention/treatment Phase
Asthma Other: telemonitoring Other: Spirometry (baseline) Other: Spirometry (20 - 22weeks) Other: Teleconsultation Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Single Group 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 : May 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: Asthma

Arm Intervention/treatment
Active Comparator: Control
Spirometry (baseline) Spirometry (20 - 22weeks)
Other: Spirometry (baseline)
Patients is evaluated by Asthma Control Test and spirometry at baseline and after 20 weeks.

Other: Spirometry (20 - 22weeks)
Patients is evaluated by Asthma Control Test and spirometry at baseline and after 20 weeks.

Experimental: Telemedicine
Spirometry (baseline) Telemonitoring Teleconsultation Spirometry (20 - 22weeks)
Other: telemonitoring
Patients is evaluated by telemonitoring (phone call nurse - 45 and 90 days).

Other: Spirometry (baseline)
Patients is evaluated by Asthma Control Test and spirometry at baseline and after 20 weeks.

Other: Spirometry (20 - 22weeks)
Patients is evaluated by Asthma Control Test and spirometry at baseline and after 20 weeks.

Other: Teleconsultation
The general practioner received phone call to asthma care.




Primary Outcome Measures :
  1. Symptoms control [ Time Frame: 20 to 22 weeks ]
    Asthma Control Test (difference three points in the questionnaire ACT)


Secondary Outcome Measures :
  1. Spirometry FVC [ Time Frame: 20 to 22 weeks ]
    Spirometry parameters - FVC (forced vital capacity)

  2. Spirometry FEV1 [ Time Frame: 20 to 22 weeks ]
    Spirometry parameters - FEV 1 (forced expiratory volume in one second)



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:

  • individual with diagnosis asthma, Asthma Control Test <20, spirometry from TelessaudeRS-Universidade Federal do Rio Grande do Sul (from randomization cluster)

Exclusion Criteria:

-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): NCT02901522


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         
Sub-Investigator: Roberto N Umpierre, Msc         
Sub-Investigator: Otavio P Davila, PhD         
Sub-Investigator: Marcelo R Gonçalves, PhD         
Sub-Investigator: Cynthia G Molina-Bastos, Md         
Sub-Investigator: Sabrina G Dalbosco, Msc         
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Federal University of Rio Grande do Sul
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Prefeitura Municipal de Porto Alegre
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: NCT02901522     History of Changes
Other Study ID Numbers: 227190 Asthma
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
asthma control test
Primary Health care
spirometry
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases