Intervention in the Management of Post-high Tuberculosis Hospital Through Educational Strategy and Oversight Distance

Pulmonary Tuberculosis Clinical Trial

Official title: Intervention in the Management of Post-high Tuberculosis Hospital Through Educational Strategy and Oversight Distance in a Region With High Prevalence of the Disease: Randomized Clinical Trial

Status Completed

Clinical Trial Summary

Brazil ranks 17th among the 22 countries responsible for 80% of tuberculosis (TB) cases in the world. In 2010, the number of new cases of tuberculosis in Brazil was 71,930 and in 4972 RS. In 2010, Brazil had a disease incidence of 37.6 / 100,000 in 2011 fell to 36.0 / 100,000. The Rio Grande do Sul(RS)S showed an incidence rate of 46.1 / 100,000 in 2011. The mortality rate was 2.4 / 100,000 population per year in Brazil and RS.

In Porto Alegre, the incidence rate of all clinical forms of tuberculosis has remained, in the last six years, around 100/100.000 inhabitants per year, while the coefficient of pulmonary tuberculosis remained on average 50/100.000 inhabitants to year. Thus, Porto Alegre holds the 2nd place in Brazil among the capitals with the highest incidence of TB, classifying the city as high risk 5th. Porto Alegre also has a co-infection TB / HIV from 35.3% one of the highest in the country.

The best strategy to prevent new cases of tuberculosis is to invest in early diagnosis and effective treatment of existing cases of the disease. As the treatment of the disease requires daily use of medications for an extended period of time (at least 6 months), adherence becomes the main determinant of the rate of healing of disease.

There are several factors that contribute to poor adherence and treatment dropout:

alcoholism, illicit drug use, infection with human immunodeficiency virus (HIV Human Immunodeficiency Virus), low education, unemployment, poor housing and prolonged the treatment. The irregular treatment and neglect are the major obstacles to the control and elimination of this disease.

Study in Porto Alegre pointed alcoholism, TB / HIV, the fact that the patient does not reside with family and low education as predictors of dropout. The dropout rate in the general population of patients with active tuberculosis was 10.7% (8.0% - 17.0%). Abandonment occurred more often within the first three meses8.

In Porto Alegre, 32.5% of new TB cases are diagnosed in hospitals. Twenty percent of these patients do not bind, after discharge, the Tuberculosis Control Program (TCP), ie, the patient egress from the hospital does not reach the basic health unit (BHU) reference for further monitoring and treatment, which is considered a serious flaw in the process control of the disease.

Clinical Trial Description

Primary objective Test the impact on the tuberculosis cure rate of an intervention based on education and supervision from a distance in the post-discharge management of new cases diagnosed in hospital. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Extra Pulmonary Tuberculosis
• Pulmonary Tuberculosis
• Tuberculosis
• Tuberculosis, Pulmonary

• NCT number: NCT02558842
• Study type: Interventional
• Source: Hospital de Clinicas de Porto Alegre
• Status: Completed
• Phase: N/A
• Start date: March 2013
• Completion date: December 2015