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

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 chronic obstructive pulmonary disease.

Detailed Description
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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.

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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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Other: Spirometry
* Other: telemonitoring
* Other: teleconsultation
* Other: Spirometry - 20 weeks


Participation Criteria
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Eligibility Criteria
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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)

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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Spirometry in baseline Spirometry - 20 weeks | Other: Spirometry<br>* Spirometry in baseline<br>Other: Spirometry - 20 weeks<br>* Spirometry (20 weeks)<br>|
| Experimental: Intervention<br>Spirometry in baseline Teleconsultation Telemonitoring Spirometry - 20 weeks | Other: Spirometry<br>* Spirometry in baseline<br>Other: telemonitoring<br>* telemonitoring (phone call nurse - 45 and 90 days)<br>Other: teleconsultation<br>* teleconsultation (general practioner received phone call to respiratory care)<br>Other: Spirometry - 20 weeks<br>* Spirometry (20 weeks)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms | Modified Medical Research Council Dyspnea Scale (difference in mMRC) | 20 a 22 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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telemedicine, chronic obstructive pulmonary disease, Primary Health care, spirometry