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

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ClinicalTrials.gov Identifier: NCT01595971
Recruitment Status : Completed
First Posted : May 10, 2012
Last Update Posted : May 15, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Asthma Behavioral: Continuing education Other: usual care

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 467 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Health Services Research
Official Title: Distance Education Versus Usual Care in the Qualification of Asthma Care: A Cluster Randomized Clinical Trial - RESPIRANET
Actual Study Start Date : August 12, 2010
Primary Completion Date : December 16, 2011
Study Completion Date : December 16, 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: continuing education
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.
Behavioral: Continuing education
Includes telemedicine, reminders, video conferences, educational materials for patients and consultants.
Other Name: RESPIRANET
Placebo Comparator: Usual Care
usual care
Other: usual care
Received the usual care provided


Outcome Measures

Primary Outcome Measures :
  1. Symptom burden, measured as the number of self-reported asthma symptom days (ASD). ASD is based on 2 week recall. [ Time Frame: six months ]
    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 :
  1. Asthma control [ Time Frame: 6 months ]
    Control of asthma will be evaluated by the excessive use of relief medication in the last month.

  2. Health care utilization [ Time Frame: 6 meses ]
    Proportion of unscheduled medical visits during the follow-up

  3. Proportion of patients in use inhaled corticosteroids [ Time Frame: 6 meses ]
    Use of inhaled corticosteroids assessed by the proportion of patients who require medication to prevent asthma symptoms that are in use of inhaled corticosteroids.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01595971


Locations
Brazil
Hospital de clínicas de Porto Alegre
Porto Alegre, Rio grande do sul, Brazil
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Federal University of Rio Grande do Sul
Investigators
Study Chair: Erno Harzheim, PHD Federal University of Rio Grande do Sul
More Information

Additional Information:
Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT01595971     History of Changes
Other Study ID Numbers: MED/FNS 774/08
First Posted: May 10, 2012    Key Record Dates
Last Update Posted: May 15, 2017
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Hospital de Clinicas de Porto Alegre:
Asthma
Continuing education
Primary health care

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases