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

NCT ID: NCT02558842

Last Updated: 2016-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2015-12-31

Brief 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.

Detailed 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.

Conditions

Pulmonary Tuberculosis; Extra Pulmonary Tuberculosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

Education Strategy

Educational Strategy and Oversight Distance

Group Type: EXPERIMENTAL

Education Strategy

Intervention Type: OTHER

Interview with the patient and their contacts, even during hospitalization, Delivering educational material about TB distribution free; Advise the patient about the BHU nearest their home, where it will follow the treatment of tuberculosis. Provide the address and telephone contact BHU this writing.

During the time of TB treatment, contact the patient to see if it is adhering to treatment and answer questions about the disease and treatment, The contact will be performed weekly for the first month, biweekly for the other months.

During the treatment period, contact BHU to monitor the progress of the case. Monitoring will be terminated: when the patient is discharged after cure of BHU or when the patient is absent for more than 30 days from the last scheduled visit.

Routine

Routine hospital assistance

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Education Strategy

Interview with the patient and their contacts, even during hospitalization, Delivering educational material about TB distribution free; Advise the patient about the BHU nearest their home, where it will follow the treatment of tuberculosis. Provide the address and telephone contact BHU this writing.

During the time of TB treatment, contact the patient to see if it is adhering to treatment and answer questions about the disease and treatment, The contact will be performed weekly for the first month, biweekly for the other months.

During the treatment period, contact BHU to monitor the progress of the case. Monitoring will be terminated: when the patient is discharged after cure of BHU or when the patient is absent for more than 30 days from the last scheduled visit.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients must be aged over 18 years.
• Diagnosis in hospital

Exclusion Criteria

• cases where there is change in diagnosis after onset of treatment
• cases reintroduction of treatment after default
• relapse cases

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of Rio Grande do Sul

OTHER

Sponsor Role: collaborator

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

Alice Manica Muller

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alice M Muller, MD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Rio Grande do Sul

Locations

Alice Mânica Müller

Porto Alegre, Rio Grande do Sul, Brazil

Countries

Brazil

Other Identifiers

13-0192

Identifier Type: -

Identifier Source: org_study_id