Status
Conditions
Treatments
Study type
Funder types
Identifiers
About
The incidence of tuberculosis has decreased over the last 2 years on the national territory (6.4/100,000 inhabitants) but remains twice as high in Ile de France where it is increasing with an increase of almost 10% in the number of cases. reported between 2015 and 2017 . the notification rate of tuberculosis disease for the year 2020 was 14.3 cases per 100,000 inhabitants (i.e. 1757 cases declared) which is more than double that found at the national level . As the disease is multifocal, patients are likely to be hospitalized in different departments with variable care and compliance support offered. One of the major issues is compliance with treatment. Indeed, INVS data (2008-2014) report a percentage of treatment completed in pulmonary tuberculosis of 73% . Among these cases, 20% had a potentially unfavorable outcome, including 45% lost to follow-up, which creates a risk of relapse and contagiousness for those around them. The latest data reported in 2022 over the period 2014-2018 seem to show an increase in treatment completeness but completeness remains variable from one region to another and from one year to another Using Public Health France data, the investigator were able to collect the proportion of completeness of treatment at Saint Antoine hospital, which is 60% over the period 2014-2016 (Public Health France, unpublished data). In more recent work carried out within the department retrospectively between 2019-2021, the investigator compared treatment outcomes depending on whether or not patients benefit from ETP support and it is 66% among patients without it. benefited, thus confirming the data from Public Health France over a more recent period.. In this context, several other studies have shown the interest of a therapeutic education program on the completeness of the treatment.
Full description
As part of a pilot study, our objective is to evaluate the benefit of a transversal therapeutic education nursing program within an AP-HP hospital in order to significantly increase the number of patients who have followed their entire treatment as recommended by the WHO Our main objective is to Evaluate the impact of a transversal therapeutic education nursing program on the outcome rate of completed anti-tuberculosis treatment in patients diagnosed with tuberculosis disease at St Antoine hospital.
The design of the study is Prospective, multicenter pilot study evaluating the impact of a transversal therapeutic education nursing program on the completeness of treatment with comparison on historical data.
40 patients over 12 months for all centers will be enroled No interim analysis was planned The analysis will be carried out at the end of the research after freezing the database, with the SAS V9.4 software.
Patient characteristics will be described by the number and proportion for qualitative variables and by their median and interquartile range for continuous variables.
The outcome rate of completed anti-tuberculosis treatment will be calculated as well as its 95% confidence interval (exact Clopper-Pearson method) and compared to the theoretical proportion of 60% by an asymptotic Wald test. A patient lost to follow-up will be considered a failure.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
40 participants in 1 patient group
Loading...
Central trial contact
Emma TORRES, Nurse; Jean-Luc MEYNARD, MD
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal