Hospital and Extra-hospital Nursing Care for Tuberculosis

NCT ID: NCT06696053

Last Updated: 2025-08-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2027-12-31

Brief Summary

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of completeness of treatment at Saint Antoine hospital, which is 60% over the period 2014-2016 (Public Health France, unpublished data).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.

Detailed 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.

Conditions

Tuberculosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Patients with Tuberculosis

Group Type: EXPERIMENTAL

Transversal therapeutic education

Intervention Type: OTHER

Additional patient consultation for therapeutic education with nurses.

Interventions

Transversal therapeutic education

Additional patient consultation for therapeutic education with nurses.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patient for whom a diagnosis of tuberculosis disease or latent tuberculosis according to the recommendations of the IDSA / CDC has been made and treatment with antituberculosis drugs started less than 3 weeks ago (9)
• Patient followed in one of the participating departments of the St Antoine hospital (internal medicine, rheumatology, gastroenterology, hepatology, geriatrics)
• Patient having signed informed consent
• Patient whose age > 18 years
• Patient affiliated to a social security scheme

Exclusion Criteria

• Patient under legal protection

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

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emma TORRES, Nurse

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Service des Maladies Infectieuses et Tropicales, Hôpital Saint-Antoine

Paris, Paris, France

Countries

France

Central Contacts

Emma TORRES, Nurse

Role: CONTACT

emma.torres@aphp.fr

+33 (0) 1 49 28 33 43

Jean-Luc MEYNARD, MD

Role: CONTACT

jean-luc.meynard@aphp.fr

+33 (0) 1 49 28 24 41

Other Identifiers

IDRCB-2024-A01634-43

Identifier Type: OTHER

Identifier Source: secondary_id

APHP240272

Identifier Type: -

Identifier Source: org_study_id