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

Study Overview
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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.

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

Conditions
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Asthma

Intervention / Treatment
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* Other: telemonitoring
* Other: Spirometry (baseline)
* Other: Spirometry (20 - 22weeks)
* Other: Teleconsultation


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Spirometry (baseline) Spirometry (20 - 22weeks) | Other: Spirometry (baseline)<br>* Patients is evaluated by Asthma Control Test and spirometry at baseline and after 20 weeks.<br>Other: Spirometry (20 - 22weeks)<br>* Patients is evaluated by Asthma Control Test and spirometry at baseline and after 20 weeks.<br>|
| Experimental: Telemedicine<br>Spirometry (baseline) Telemonitoring Teleconsultation Spirometry (20 - 22weeks) | Other: telemonitoring<br>* Patients is evaluated by telemonitoring (phone call nurse - 45 and 90 days).<br>Other: Spirometry (baseline)<br>* Patients is evaluated by Asthma Control Test and spirometry at baseline and after 20 weeks.<br>Other: Spirometry (20 - 22weeks)<br>* Patients is evaluated by Asthma Control Test and spirometry at baseline and after 20 weeks.<br>Other: Teleconsultation<br>* The general practioner received phone call to asthma care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms control | Asthma Control Test (difference three points in the questionnaire ACT) | 20 to 22 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spirometry FVC | Spirometry parameters - FVC (forced vital capacity) | 20 to 22 weeks | 
| Spirometry FEV1 | Spirometry parameters - FEV 1 (forced expiratory volume in one second) | 20 to 22 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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telemedicine, asthma control test, Primary Health care, spirometry