CClinicalTrials.gg
Status unknownNCT02901535RESPIRANET-CUpdated Jan 18, 2017

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

An interventional study of Spirometry and telemonitoring in Chronic Obstructive Pulmonary Disease, sponsored by Hospital de Clinicas de Porto Alegre. Status unknown at 1 site in Brazil. Open to participants aged 12 Years to 100 Years. Per ClinicalTrials.gov, last updated 2017-01-18.

Sponsored by Hospital de Clinicas de Porto Alegre · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
240
Allocation
Randomized
Ages
12 Years to 100 Years
Sex
All
01

Study summary

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

Read the 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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Conditions studied

  • Chronic Obstructive Pulmonary Disease

Keywords

  • telemedicine
  • chronic obstructive pulmonary disease
  • Primary Health care
  • spirometry
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In context

Lung Diseases

3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's planned enrollment of 240 is above the median of 72 across 2,118 interventional studies indexed under Lung Diseases.

Browse Lung Diseases studies →

Lead sponsor

Hospital de Clinicas de Porto Alegre is the lead sponsor of 450 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
12 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
240 participants (estimated)

Study arms

  • Active comparator
    Control

    Spirometry in baseline Spirometry - 20 weeks

    Other: Spirometry · Other: Spirometry - 20 weeks

  • Experimental
    Intervention

    Spirometry in baseline Teleconsultation Telemonitoring Spirometry - 20 weeks

    Other: Spirometry · Other: telemonitoring · Other: teleconsultation · Other: Spirometry - 20 weeks

Interventions

  • OtherSpirometry

    Spirometry in baseline

  • Othertelemonitoring

    telemonitoring (phone call nurse - 45 and 90 days)

  • Otherteleconsultation

    teleconsultation (general practioner received phone call to respiratory care)

  • OtherSpirometry - 20 weeks

    Spirometry (20 weeks)

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What researchers measure

Primary outcomes

  1. Symptoms

    Modified Medical Research Council Dyspnea Scale (difference in mMRC)

    Time frame: 20 a 22 weeks

Secondary outcomes

  1. Spirometry - FEV1

    spirometry parameters - FEV 1 (forced expiratory volume in one second)

    Time frame: 20 a 22 weeks

  2. Spirometry - FVC

    spirometry parameters - FVC (forced vital capacity)

    Time frame: 20 a 22 weeks

07

Study locations

1 of 1 sites recruiting
  • TelessaudeRS-Universidade Federal do Rio Grande do Sul
    Porto Alegre, Rio Grande do Sul 90670000, Brazil
    • Cynthia G Molina-Bastos, MD · Contact · cyncarol@gmail.com · 5191322585
    • Marcelo R. Gonçalves, PhD · Contact · marcelorog@gmail.com · 5191175156
    • Maria Angela F Moreira, PhD · Sub investigator
    • Dimitris V Rados, Msc · Sub investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 18, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02901535
Lead sponsor
Hospital de Clinicas de Porto Alegre
Collaborators
Federal University of Rio Grande do Sul, Conselho Nacional de Desenvolvimento Científico e Tecnológico, Ministry of Health, Brazil
Responsible party
Sponsor
First posted
Sep 15, 2016
Start date
Apr 2015
Primary completion
Jul 2017 (estimated)
Completion
Dec 2017 (estimated)
Last update
Jan 18, 2017

Study contacts

Marcelo R. Gonçalves, PhD
Contact
marcelorog@gmail.com
5191175156 ext. +55
Cynthia G Molina-Bastos, MD
Contact
cyncarol@gmail.com
5191322585 ext. +55
Erno Harzheim, PhD
principal investigator · Federal University of Rio Grande do Sul

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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