Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02558842
Recruitment Status : Completed
First Posted : September 24, 2015
Last Update Posted : August 3, 2016
Sponsor:
Collaborator:
Federal University of Rio Grande do Sul
Information provided by (Responsible Party):
Alice Manica Muller, Hospital de Clinicas de Porto Alegre

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.


Condition or disease Intervention/treatment Phase
Pulmonary Tuberculosis Extra Pulmonary Tuberculosis Other: Education Strategy Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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
Study Start Date : March 2013
Actual Primary Completion Date : September 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Education Strategy
Educational Strategy and Oversight Distance
Other: 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.


No Intervention: Routine
Routine hospital assistance



Primary Outcome Measures :
  1. cure rate [ Time Frame: proposed time of treatment (up to 24 weeks, according to the shape of the disease and the treatment used), and which has favorable performance clinical and / or radiological and / or bacteriological until the end of treatment ]

Secondary Outcome Measures :
  1. dropout rate [ Time Frame: it is considered abandonment cases that were without medication for more than 30 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT02558842


Locations
Layout table for location information
Brazil
Alice Mânica Müller
Porto Alegre, Rio Grande do Sul, Brazil
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Federal University of Rio Grande do Sul
Investigators
Layout table for investigator information
Principal Investigator: Alice M Muller, MD Federal University of Rio Grande do Sul

Layout table for additonal information
Responsible Party: Alice Manica Muller, Principal Investigator, Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT02558842     History of Changes
Other Study ID Numbers: 13-0192
First Posted: September 24, 2015    Key Record Dates
Last Update Posted: August 3, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Additional relevant MeSH terms:
Layout table for MeSH terms
Tuberculosis
Tuberculosis, Pulmonary
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections