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

NCT ID: NCT02901535

Last Updated: 2017-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2017-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Control

Spirometry in baseline Spirometry - 20 weeks

Group Type ACTIVE_COMPARATOR

Spirometry

Intervention Type OTHER

Spirometry in baseline

Spirometry - 20 weeks

Intervention Type OTHER

Spirometry (20 weeks)

Intervention

Spirometry in baseline Teleconsultation Telemonitoring Spirometry - 20 weeks

Group Type EXPERIMENTAL

Spirometry

Intervention Type OTHER

Spirometry in baseline

telemonitoring

Intervention Type OTHER

telemonitoring (phone call nurse - 45 and 90 days)

teleconsultation

Intervention Type OTHER

teleconsultation (general practioner received phone call to respiratory care)

Spirometry - 20 weeks

Intervention Type OTHER

Spirometry (20 weeks)

Interventions

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Spirometry

Spirometry in baseline

Intervention Type OTHER

telemonitoring

telemonitoring (phone call nurse - 45 and 90 days)

Intervention Type OTHER

teleconsultation

teleconsultation (general practioner received phone call to respiratory care)

Intervention Type OTHER

Spirometry - 20 weeks

Spirometry (20 weeks)

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

12 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of Rio Grande do Sul

OTHER

Sponsor Role collaborator

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role collaborator

Ministry of Health, Brazil

OTHER_GOV

Sponsor Role collaborator

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Erno Harzheim, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Rio Grande do Sul

Locations

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TelessaudeRS-Universidade Federal do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Marcelo R. Gonçalves, PhD

Role: CONTACT

5191175156 ext. +55

Cynthia G Molina-Bastos, MD

Role: CONTACT

5191322585 ext. +55

Facility Contacts

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Cynthia G Molina-Bastos, MD

Role: primary

5191322585 ext. +55

Marcelo R. Gonçalves, PhD

Role: backup

5191175156 ext. +55

Other Identifiers

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227190 COPD

Identifier Type: -

Identifier Source: org_study_id

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