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

NCT ID: NCT02901522

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

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

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 asthma.

Detailed Description

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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.

Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Control

Spirometry (baseline) Spirometry (20 - 22weeks)

Group Type ACTIVE_COMPARATOR

Spirometry (baseline)

Intervention Type OTHER

Patients is evaluated by Asthma Control Test and spirometry at baseline and after 20 weeks.

Spirometry (20 - 22weeks)

Intervention Type OTHER

Patients is evaluated by Asthma Control Test and spirometry at baseline and after 20 weeks.

Telemedicine

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

Group Type EXPERIMENTAL

telemonitoring

Intervention Type OTHER

Patients is evaluated by telemonitoring (phone call nurse - 45 and 90 days).

Spirometry (baseline)

Intervention Type OTHER

Patients is evaluated by Asthma Control Test and spirometry at baseline and after 20 weeks.

Spirometry (20 - 22weeks)

Intervention Type OTHER

Patients is evaluated by Asthma Control Test and spirometry at baseline and after 20 weeks.

Teleconsultation

Intervention Type OTHER

The general practioner received phone call to asthma care.

Interventions

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telemonitoring

Patients is evaluated by telemonitoring (phone call nurse - 45 and 90 days).

Intervention Type OTHER

Spirometry (baseline)

Patients is evaluated by Asthma Control Test and spirometry at baseline and after 20 weeks.

Intervention Type OTHER

Spirometry (20 - 22weeks)

Patients is evaluated by Asthma Control Test and spirometry at baseline and after 20 weeks.

Intervention Type OTHER

Teleconsultation

The general practioner received phone call to asthma care.

Intervention Type OTHER

Eligibility Criteria

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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)
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

Prefeitura Municipal de Porto Alegre

UNKNOWN

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 Asthma

Identifier Type: -

Identifier Source: org_study_id

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