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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01595971
Other study ID # MED/FNS 774/08
Secondary ID
Status Completed
Phase N/A
First received May 9, 2012
Last updated May 12, 2017
Start date August 12, 2010
Est. completion date December 16, 2011

Study information

Verified date September 2016
Source Hospital de Clinicas de Porto Alegre
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 467
Est. completion date December 16, 2011
Est. primary completion date December 16, 2011
Accepts healthy volunteers No
Gender All
Age group 5 Years to 45 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Continuing education
Includes telemedicine, reminders, video conferences, educational materials for patients and consultants.
Other:
usual care
Received the usual care provided

Locations

Country Name City State
Brazil Hospital de clínicas de Porto Alegre Porto Alegre Rio grande do sul

Sponsors (3)

Lead Sponsor Collaborator
Hospital de Clinicas de Porto Alegre Federal University of Rio Grande do Sul, TelessaúdeRS-Universidade Federal do Rio Grande do Sul

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. six months
Secondary Asthma control Control of asthma will be evaluated by the excessive use of relief medication in the last month. 6 months
Secondary Health care utilization Proportion of unscheduled medical visits during the follow-up 6 meses
Secondary 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. 6 meses
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