TuberculosisFOLLOWTUBNCT06696053
Hospital and Extra-hospital Nursing Care for Tuberculosis
A study testing Transversal therapeutic education in people with Tuberculosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tuberculosis
- What is being tested?
- Transversal therapeutic education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2026to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patient under legal protection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Service des Maladies Infectieuses et Tropicales, Hôpital Saint-Antoine
Paris, Paris, 75012
About this study
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.
Read the 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
- Being tested
- Transversal therapeutic education
- Keywords
- Tuberculosis, education nursing program
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transversal therapeutic educationOther
Additional patient consultation for therapeutic education with nurses.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Tuberculosis | Experimental | Not described Receives: Other: Transversal therapeutic education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 6, 9 and 12 month post inclusion
Secondary outcomes (7)
Rate of patients lost to follow-up among patients included
Measured: 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
via questionnaires
Measured: 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
via questionnaires
Measured: At inclusion visite,1, 6, 9 and 12 months after inclusion
Evolution of patients' quality of life before and at the end of treatment
SF36 scale
Measured: At inclusion visite,1, 6, 9 and 12 months after inclusion
Caregivers' program satisfaction scale
via questionnaires
Measured: At inclusion visit and at 12 month
Patient Program Satisfaction Scale
Measured: At inclusion visite,1, 6, 9 and 12 months after inclusion
Number of meetings of the network for monitoring the most vulnerable patients between the city and the hospital involving the Samu social coordinated by the infectious diseases department
Measured: through the study completion and up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study startSep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emma TORRES, Nurse, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06696053
- Sponsor's protocol ID
- APHP240272
- Other IDs
- IDRCB-2024-A00132-45
- Acronym
- FOLLOWTUB
- Status last verified
- Aug 2025
- First submitted
- 18 Nov 2024
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hospital and Extra-hospital Nursing Care for Tuberculosis
- ClinicalTrials.gov ID
- NCT06696053
- Acronym / sponsor ID
- FOLLOWTUB / APHP240272
- Conditions
- Tuberculosis
- Keywords
- Tuberculosis, education nursing program
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 19 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Tuberculosis | Experimental | Other: Transversal therapeutic education |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Patient under legal protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transversal therapeutic educationAdditional patient consultation for therapeutic education with nurses. | Other | Patients with Tuberculosis |
Primary outcome
Rate of outcomes of completed antituberculosis treatment
Time frame: At 6, 9 and 12 month post inclusion
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.
7 secondary outcomes
Rate of patients lost to follow-up among patients included
Time frame: 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
Time frame: 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
Time frame: At inclusion visite,1, 6, 9 and 12 months after inclusion
Evolution of patients' quality of life before and at the end of treatment
Time frame: At inclusion visite,1, 6, 9 and 12 months after inclusion
Caregivers' program satisfaction scale
Time frame: At inclusion visit and at 12 month
Patient Program Satisfaction Scale
Time frame: At inclusion visite,1, 6, 9 and 12 months after inclusion
Number of meetings of the network for monitoring the most vulnerable patients between the city and the hospital involving the Samu social coordinated by the infectious diseases department
Time frame: through the study completion and up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emma TORRES, Nurse principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transversal therapeutic education in people with Tuberculosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emma TORRES, Nurse (+33 (0) 1 49 28 33 43, emma.torres@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of outcomes of completed antituberculosis treatment (time frame: At 6, 9 and 12 month post inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.