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

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 chronic obstructive pulmonary disease.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

240

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

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 (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

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: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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: Spirometry - 20 weeks
Spirometry (20 weeks)
Other: telemonitoring
telemonitoring (phone call nurse - 45 and 90 days)
Other: teleconsultation
teleconsultation (general practioner received phone call to respiratory care)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptoms
Time Frame: 20 a 22 weeks
Modified Medical Research Council Dyspnea Scale (difference in mMRC)
20 a 22 weeks

Secondary Outcome Measures

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

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

April 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 COPD

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.

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