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NCT02901522 Clinical Trial

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

Asthma Clinical Trial

— RESPIRANET-A  

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 NCT02901522
Other study ID # 227190 Asthma
Secondary ID
Status Recruiting
Phase N/A
First received September 12, 2016
Last updated January 16, 2017
Start date May 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 asthma.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 120
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:

- 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

Related Conditions & MeSH terms

Intervention

Other:
• telemonitoring
Patients is evaluated by telemonitoring (phone call nurse - 45 and 90 days).
• Spirometry (baseline)
Patients is evaluated by Asthma Control Test and spirometry at baseline and after 20 weeks.
• Spirometry (20 - 22weeks)
Patients is evaluated by Asthma Control Test and spirometry at baseline and after 20 weeks.
• Teleconsultation
The general practioner received phone call to asthma care.

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

Sponsors (6)
Lead Sponsor Collaborator
Hospital de Clinicas de Porto Alegre Conselho Nacional de Desenvolvimento Científico e Tecnológico, Ministry of Health, Brazil, Prefeitura Municipal de Porto Alegre, TelessaúdeRS-Universidade Federal do Rio Grande do Sul, Universidade Federal do Rio Grande do Sul - Programa de Pós-graduação em Epidemiologia

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary Symptoms control Asthma Control Test (difference three points in the questionnaire ACT) 20 to 22 weeks
Secondary Spirometry FVC Spirometry parameters - FVC (forced vital capacity) 20 to 22 weeks
Secondary Spirometry FEV1 Spirometry parameters - FEV 1 (forced expiratory volume in one second) 20 to 22 weeks
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