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

Primary Purpose

Asthma

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
telemonitoring
Spirometry (baseline)
Spirometry (20 - 22weeks)
Teleconsultation
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring telemedicine, asthma control test, Primary Health care, spirometry

Eligibility Criteria

12 Years - 100 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • TelessaudeRS-Universidade Federal do Rio Grande do SulRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

Telemedicine

Arm Description

Spirometry (baseline) Spirometry (20 - 22weeks)

Spirometry (baseline) Telemonitoring Teleconsultation Spirometry (20 - 22weeks)

Outcomes

Primary Outcome Measures

Symptoms control
Asthma Control Test (difference three points in the questionnaire ACT)

Secondary Outcome Measures

Spirometry FVC
Spirometry parameters - FVC (forced vital capacity)
Spirometry FEV1
Spirometry parameters - FEV 1 (forced expiratory volume in one second)

Full Information

First Posted
September 12, 2016
Last Updated
January 16, 2017
Sponsor
Hospital de Clinicas de Porto Alegre
Collaborators
Federal University of Rio Grande do Sul, Conselho Nacional de Desenvolvimento Científico e Tecnológico, Prefeitura Municipal de Porto Alegre, Ministry of Health, Brazil
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1. Study Identification

Unique Protocol Identification Number
NCT02901522
Brief Title
Tele-spirometry in Primary Care - Randomized Clinical Trial Cluster: the Effectiveness of Telemedicine in Asthma
Acronym
RESPIRANET-A
Official Title
Tele-spirometry in Primary Care - Randomized Clinical Trial Cluster: the Effectiveness of Multifaceted Intervention in Symptoms Patients With Respiratory Illness.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 2015 (undefined)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre
Collaborators
Federal University of Rio Grande do Sul, Conselho Nacional de Desenvolvimento Científico e Tecnológico, Prefeitura Municipal de Porto Alegre, Ministry of Health, Brazil

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine the effectiveness of telemedicine multifaceted intervention in symptoms patients with asthma.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
telemedicine, asthma control test, Primary Health care, spirometry

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
Spirometry (baseline) Spirometry (20 - 22weeks)
Arm Title
Telemedicine
Arm Type
Experimental
Arm Description
Spirometry (baseline) Telemonitoring Teleconsultation Spirometry (20 - 22weeks)
Intervention Type
Other
Intervention Name(s)
telemonitoring
Intervention Description
Patients is evaluated by telemonitoring (phone call nurse - 45 and 90 days).
Intervention Type
Other
Intervention Name(s)
Spirometry (baseline)
Intervention Description
Patients is evaluated by Asthma Control Test and spirometry at baseline and after 20 weeks.
Intervention Type
Other
Intervention Name(s)
Spirometry (20 - 22weeks)
Intervention Description
Patients is evaluated by Asthma Control Test and spirometry at baseline and after 20 weeks.
Intervention Type
Other
Intervention Name(s)
Teleconsultation
Intervention Description
The general practioner received phone call to asthma care.
Primary Outcome Measure Information:
Title
Symptoms control
Description
Asthma Control Test (difference three points in the questionnaire ACT)
Time Frame
20 to 22 weeks
Secondary Outcome Measure Information:
Title
Spirometry FVC
Description
Spirometry parameters - FVC (forced vital capacity)
Time Frame
20 to 22 weeks
Title
Spirometry FEV1
Description
Spirometry parameters - FEV 1 (forced expiratory volume in one second)
Time Frame
20 to 22 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marcelo R. Gonçalves, PhD
Phone
5191175156
Ext
+55
Email
marcelorog@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Cynthia G Molina-Bastos, MD
Phone
5191322585
Ext
+55
Email
cyncarol@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erno Harzheim, PhD
Organizational Affiliation
Federal University of Rio Grande do Sul
Official's Role
Principal Investigator
Facility Information:
Facility Name
TelessaudeRS-Universidade Federal do Rio Grande do Sul
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90670000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cynthia G Molina-Bastos, MD
Phone
5191322585
Ext
+55
Email
cyncarol@gmail.com
First Name & Middle Initial & Last Name & Degree
Marcelo R Gonçalves, PhD
Phone
5191175156
Ext
+55
Email
marcelorog@gmail.com
First Name & Middle Initial & Last Name & Degree
Maria Angela F Moreira, PhD
First Name & Middle Initial & Last Name & Degree
Dimitris V Rados, Msc
First Name & Middle Initial & Last Name & Degree
Roberto N Umpierre, Msc
First Name & Middle Initial & Last Name & Degree
Otavio P Davila, PhD
First Name & Middle Initial & Last Name & Degree
Marcelo R Gonçalves, PhD
First Name & Middle Initial & Last Name & Degree
Cynthia G Molina-Bastos, Md
First Name & Middle Initial & Last Name & Degree
Sabrina G Dalbosco, Msc

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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