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Distance Education Versus Usual Care Qualification in Asthma Care (RESPIRANET)

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Continuing education
usual care
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Asthma focused on measuring Asthma, Continuing education, Primary health care

Eligibility Criteria

5 Years - 45 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Practice:Participate in the Telessaúde/RS. Minimal staff consisting of a general practitioner, nurse, nurse and community health agents (CHA), ability to give at least ten patients diagnosed with asthma, located in a municipality to make available for free inhaled medication (short-acting bronchodilators and corticosteroids ) for the treatment of asthma and willingness to participate in the study.
  • Patients: 5 to 45 years with a diagnosis of asthma made by a physician and register at least one consultation for asthma or an asthma-related hospitalization during the year preceding the beginning of the study.

Exclusion Criteria:

  • Patients with other chronic diseases with pulmonary complications such as tuberculosis, cancer and cystic fibrosis or those with severe mental illness

Sites / Locations

  • Hospital de clínicas de Porto Alegre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

continuing education

Usual Care

Arm Description

RESPIRANET is a multifaceted intervention directed at professionals of the Family Health Teams in the inner cities.Includes telemedicine, reminders, video conferences, educational materials for patients and consultants.

usual care

Outcomes

Primary Outcome Measures

Symptom burden, measured as the number of self-reported asthma symptom days (ASD). ASD is based on 2 week recall.
The definition of a symptom day includes presence of any of the four types of asthma symptoms: wheeze, cough, night time awakening ou shortness of breath. The results will be collected through the application of standardized questionnaires.

Secondary Outcome Measures

Asthma control
Control of asthma will be evaluated by the excessive use of relief medication in the last month.
Health care utilization
Proportion of unscheduled medical visits during the follow-up
Proportion of patients in use inhaled corticosteroids
Use of inhaled corticosteroids assessed by the proportion of patients who require medication to prevent asthma symptoms that are in use of inhaled corticosteroids.

Full Information

First Posted
May 9, 2012
Last Updated
May 12, 2017
Sponsor
Hospital de Clinicas de Porto Alegre
Collaborators
Federal University of Rio Grande do Sul
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1. Study Identification

Unique Protocol Identification Number
NCT01595971
Brief Title
Distance Education Versus Usual Care Qualification in Asthma Care
Acronym
RESPIRANET
Official Title
Distance Education Versus Usual Care in the Qualification of Asthma Care: A Cluster Randomized Clinical Trial - RESPIRANET
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
August 12, 2010 (Actual)
Primary Completion Date
December 16, 2011 (Actual)
Study Completion Date
December 16, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre
Collaborators
Federal University of Rio Grande do Sul

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the effectiveness of multifaceted educational interventions in the care of asthma, conducted remotely over the platform TelessaúdeRS in teams of the Family Health Strategy and the consequent clinical improvement patients.
Detailed Description
Cluster-randomized trial with follow-up of 6 months. The aim of this study is to determine whether multifaceted interventions performed at a distance for the care of asthma symptoms reduce overhead, improve asthma control and qualify the care provided to patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Continuing education, Primary health care

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
467 (Actual)

8. Arms, Groups, and Interventions

Arm Title
continuing education
Arm Type
Experimental
Arm Description
RESPIRANET is a multifaceted intervention directed at professionals of the Family Health Teams in the inner cities.Includes telemedicine, reminders, video conferences, educational materials for patients and consultants.
Arm Title
Usual Care
Arm Type
Placebo Comparator
Arm Description
usual care
Intervention Type
Behavioral
Intervention Name(s)
Continuing education
Other Intervention Name(s)
RESPIRANET
Intervention Description
Includes telemedicine, reminders, video conferences, educational materials for patients and consultants.
Intervention Type
Other
Intervention Name(s)
usual care
Intervention Description
Received the usual care provided
Primary Outcome Measure Information:
Title
Symptom burden, measured as the number of self-reported asthma symptom days (ASD). ASD is based on 2 week recall.
Description
The definition of a symptom day includes presence of any of the four types of asthma symptoms: wheeze, cough, night time awakening ou shortness of breath. The results will be collected through the application of standardized questionnaires.
Time Frame
six months
Secondary Outcome Measure Information:
Title
Asthma control
Description
Control of asthma will be evaluated by the excessive use of relief medication in the last month.
Time Frame
6 months
Title
Health care utilization
Description
Proportion of unscheduled medical visits during the follow-up
Time Frame
6 meses
Title
Proportion of patients in use inhaled corticosteroids
Description
Use of inhaled corticosteroids assessed by the proportion of patients who require medication to prevent asthma symptoms that are in use of inhaled corticosteroids.
Time Frame
6 meses

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Practice:Participate in the Telessaúde/RS. Minimal staff consisting of a general practitioner, nurse, nurse and community health agents (CHA), ability to give at least ten patients diagnosed with asthma, located in a municipality to make available for free inhaled medication (short-acting bronchodilators and corticosteroids ) for the treatment of asthma and willingness to participate in the study. Patients: 5 to 45 years with a diagnosis of asthma made by a physician and register at least one consultation for asthma or an asthma-related hospitalization during the year preceding the beginning of the study. Exclusion Criteria: Patients with other chronic diseases with pulmonary complications such as tuberculosis, cancer and cystic fibrosis or those with severe mental illness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erno Harzheim, PHD
Organizational Affiliation
Federal University of Rio Grande do Sul
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital de clínicas de Porto Alegre
City
Porto Alegre
State/Province
Rio grande do sul
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Links:
URL
http://www.ufrgs.br/telessauders
Description
Collaborator website

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Distance Education Versus Usual Care Qualification in Asthma Care

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