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NCT02901535 Clinical Trial

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

Chronic Obstructive Pulmonary Disease Clinical Trial

— RESPIRANET-C  

Official title:
Tele-spirometry in Primary Care - Randomized Clinical Trial Cluster: the Effectiveness of Multifaceted Intervention in Symptoms Patients With Respiratory Illness

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02901535
Other study ID # 227190 COPD
Secondary ID
Status Recruiting
Phase N/A
First received September 12, 2016
Last updated January 16, 2017
Start date April 2015
Est. completion date December 2017

Study information
Verified date January 2017
Source Hospital de Clinicas de Porto Alegre
Contact Marcelo R. Gonçalves, PhD
Phone 5191175156
Email marcelorog@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 240
Est. completion date December 2017
Est. primary completion date July 2017
Accepts healthy volunteers No
Gender All
Age group 12 Years to 100 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Spirometry
Spirometry in baseline
• telemonitoring
telemonitoring (phone call nurse - 45 and 90 days)
• teleconsultation
teleconsultation (general practioner received phone call to respiratory care)
• Spirometry - 20 weeks
Spirometry (20 weeks)

Locations
Country Name City State
Brazil TelessaudeRS-Universidade Federal do Rio Grande do Sul Porto Alegre Rio Grande do Sul

Sponsors (5)
Lead Sponsor Collaborator
Hospital de Clinicas de Porto Alegre Conselho Nacional de Desenvolvimento Científico e Tecnológico, Ministry of Health, Brazil, Programa de Pos-graduação em Epidemiologia - Universidade Federal do Rio Grande do Sul, TelessaúdeRS-Universidade Federal do Rio Grande do Sul

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary Symptoms Modified Medical Research Council Dyspnea Scale (difference in mMRC) 20 a 22 weeks
Secondary Spirometry - FEV1 spirometry parameters - FEV 1 (forced expiratory volume in one second) 20 a 22 weeks
Secondary Spirometry - FVC spirometry parameters - FVC (forced vital capacity) 20 a 22 weeks
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