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

Not Applicable

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Other: Spirometry; Other: Spirometry - 20 weeks; Other: telemonitoring; Other: teleconsultation

• Registration Number: NCT02901535
• 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 chronic obstructive pulmonary disease.

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 Timeline

• Study Start: 2015-04
• 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: 240

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Spirometry	Spirometry in baseline Spirometry - 20 weeks
Intervention	Spirometry	Spirometry in baseline Teleconsultation Telemonitoring Spirometry - 20 weeks
Control	Spirometry - 20 weeks	Spirometry in baseline Spirometry - 20 weeks
Intervention	telemonitoring	Spirometry in baseline Teleconsultation Telemonitoring Spirometry - 20 weeks
Intervention	teleconsultation	Spirometry in baseline Teleconsultation Telemonitoring Spirometry - 20 weeks
Intervention	Spirometry - 20 weeks	Spirometry in baseline Teleconsultation Telemonitoring Spirometry - 20 weeks

Primary Outcome Measures

Name	Time	Method
Symptoms	20 a 22 weeks	Modified Medical Research Council Dyspnea Scale (difference in mMRC)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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