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

January 16, 2017 updated by: Hospital de Clinicas de Porto Alegre

Tele-spirometry in Primary Care - Randomized Clinical Trial Cluster: the Effectiveness of Multifaceted Intervention in Symptoms Patients With Respiratory Illness.

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90670000
        • Recruiting
        • TelessaudeRS-Universidade Federal do Rio Grande do Sul
        • Contact:
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 100 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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: 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: telemonitoring
Patients is evaluated by telemonitoring (phone call nurse - 45 and 90 days).
Other: Teleconsultation
The general practioner received phone call to asthma care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptoms control
Time Frame: 20 to 22 weeks
Asthma Control Test (difference three points in the questionnaire ACT)
20 to 22 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spirometry FVC
Time Frame: 20 to 22 weeks
Spirometry parameters - FVC (forced vital capacity)
20 to 22 weeks
Spirometry FEV1
Time Frame: 20 to 22 weeks
Spirometry parameters - FEV 1 (forced expiratory volume in one second)
20 to 22 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Clinicas de Porto Alegre

Collaborators

Federal University of Rio Grande do Sul
Ministry of Health, Brazil
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Prefeitura Municipal de Porto Alegre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Anticipated)

July 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

September 12, 2016

First Submitted That Met QC Criteria

September 12, 2016

First Posted (Estimate)

September 15, 2016

Study Record Updates

Last Update Posted (Estimate)

January 18, 2017

Last Update Submitted That Met QC Criteria

January 16, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 227190 Asthma

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Asthma

Clinical Trials on Spirometry (baseline)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Romania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe