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

Not Applicable

• Conditions: Asthma
• Interventions: Other: telemonitoring; Other: Spirometry (20 - 22weeks); Other: Spirometry (baseline); Other: Teleconsultation

• Registration Number: NCT02901522
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

Brief Summary

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

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 Timeline

• Study Start: 2015-05
• Study First Submitted: 2016-09-12
• Study First Submitted QC: 2016-09-12
• Study First Posted: 2016-09-15
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-16
• Last Update Posted: 2017-01-18
• Primary Completion: 2017-07
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Control	Spirometry (20 - 22weeks)	Spirometry (baseline) Spirometry (20 - 22weeks)
Telemedicine	telemonitoring	Spirometry (baseline) Telemonitoring Teleconsultation Spirometry (20 - 22weeks)
Telemedicine	Spirometry (20 - 22weeks)	Spirometry (baseline) Telemonitoring Teleconsultation Spirometry (20 - 22weeks)
Telemedicine	Spirometry (baseline)	Spirometry (baseline) Telemonitoring Teleconsultation Spirometry (20 - 22weeks)
Control	Spirometry (baseline)	Spirometry (baseline) Spirometry (20 - 22weeks)
Telemedicine	Teleconsultation	Spirometry (baseline) Telemonitoring Teleconsultation Spirometry (20 - 22weeks)

Primary Outcome Measures

Name	Time	Method
Symptoms control	20 to 22 weeks	Asthma Control Test (difference three points in the questionnaire ACT)

Secondary Outcome Measures

Name	Time	Method
Spirometry FVC	20 to 22 weeks	Spirometry parameters - FVC (forced vital capacity)
Spirometry FEV1	20 to 22 weeks	Spirometry parameters - FEV 1 (forced expiratory volume in one second)

Trial Locations

Locations (1)

TelessaudeRS-Universidade Federal do Rio Grande do Sul; 🇧🇷 Porto Alegre, Rio Grande do Sul, Brazil