Hospital and Extra-hospital Nursing Care for Tuberculosis

NCT06696053 | Not Yet Recruiting

• 2 other identifiers: APHP240272IDRCB-2024-A00132-45
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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of completeness of treatment at Saint Antoine hospital, which is 60% over the period 2014-2016 (Public Health France, unpublished data).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

Conditions

Tuberculosis

Keywords

Tuberculosis; education nursing program

Outcome Measures

Primary Outcomes (1)

• Rate of outcomes of completed antituberculosis treatment

  A favorable treatment outcome will be defined by a composite criterion, namely: treatment compliance \> 80% (self-questionnaire during visits), 80% of visits honored and clinical cure for the referring physician.

  At 6, 9 and 12 month post inclusion

Secondary Outcomes (7)

• Rate of patients lost to follow-up among patients included

  At 6 and 12 month post inclusion

• Rate of caregivers showing an improvement in their knowledge before and after the implementation of the training and information action on tuberculosis

  At inclusion and at 12 month

• Rate of patients showing improvement in their knowledge before and after the implementation of the training and information action on tuberculosis

  At inclusion visite,1, 6, 9 and 12 months after inclusion

• Evolution of patients' quality of life before and at the end of treatment

  At inclusion visite,1, 6, 9 and 12 months after inclusion

• Caregivers' program satisfaction scale

  At inclusion visit and at 12 month

Study Arms (1)

Patients with Tuberculosis

EXPERIMENTAL

Other: Transversal therapeutic education

Interventions

Transversal therapeutic education OTHER

Additional patient consultation for therapeutic education with nurses.

Patients with Tuberculosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patient under legal protection

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Service des Maladies Infectieuses et Tropicales, Hôpital Saint-Antoine

Paris, Paris, 75012, France

Location

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Emma TORRES, Nurse

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emma TORRES, Nurse

CONTACT

+33 (0) 1 49 28 33 43; emma.torres@aphp.fr

Jean-Luc MEYNARD, MD

CONTACT

+33 (0) 1 49 28 24 41; jean-luc.meynard@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: November 19, 2024
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: April 24, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)