Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06574529
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-25
Brief Title:
Video-observed Therapy for Active Tuberculosis a Feasibility Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Video-observed Therapy vDOT as a Surrogate to Directly Observed Therapy DOT for Active Tuberculosis a Feasibility Study in a Low Incidence High-income Area
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Tuberculosis TB is still present in Switzerland and concerns mainly foreign-born subjects Monitoring compliance to treatment by Directly Observed Therapy DOT is strongly encouraged by the World Health Organization WHO It is however time-consuming costly and stigmatising This study aims to examine the feasibility of monitoring compliance through a secured web platform and videos sent via an application on a cellphone a concept known as vDOT Video-observed therapy The study aims to include all patients treated for tuberculosis is on our area during an 18 month period and monitor acceptance compliance and technical issues related to vDOT
Detailed Description:
The study aims to include all patients who are treated de novo for active tuberculosis is our area The aim of this study was to show that vDOT was feasible in a low-incidence high income area that it had a high acceptance rate among patients and health-care professionals with a low rate of technical difficulties or pitfalls
All patients with a diagnosis of tuberculosis irrespective of sites of infection were invited to participate in this study The Division of Pulmonology of Geneva University Hospital diagnoses and follows virtually all cases of tuberculosis in the Canton of Geneva Annual number of cases in Geneva between 2020 and 2023 was on average 43year range 36-53 Incidence was 7-103105 inhabitants compared to a national incidence of 399-472 105 inhabitants during the same period
Specialized TB nurses were trained to use the vDOT platform and provided the training with the help of translators whenever required The application APP was installed with the patient and a test video was sent to the platform The APP uses simple understandable pictograms and is thus not per se language-dependent vDOT was started as soon as possible after initiation of TB treatment either during a hospital stay or during the first outpatient follow-up visit at our centre Whenever necessary a portable cell phone was provided for the patient for the duration of the treatment
The SureAdhere platform was used for vDOT httpsdimagicomsureadhere Once the videos have been recorded they are sent automatically as soon as the patients cell phone has access to internet
For each patient the number of videos to be sent each week was specified 5 as default option
All patients with a diagnosis of tuberculosis irrespective of sites of infection were invited to participate in this study The Division of Pulmonology of Geneva University Hospital diagnoses and follows virtually all cases of tuberculosis in the Canton of Geneva Annual number of cases in Geneva between 2020 and 2023 was on average 43year range 36-53 Incidence was 7-103105 inhabitants compared to a national incidence of 399-472 105 inhabitants during the same period
Specialized TB nurses were trained to use the vDOT platform and provided the training with the help of translators whenever required The application APP was installed with the patient and a test video was sent to the platform The APP uses simple understandable pictograms and is thus not per se language-dependent vDOT was started as soon as possible after initiation of TB treatment either during a hospital stay or during the first outpatient follow-up visit at our centre Whenever necessary a portable cell phone was provided for the patient for the duration of the treatment
The SureAdhere platform was used for vDOT httpsdimagicomsureadhere Once the videos have been recorded they are sent automatically as soon as the patients cell phone has access to internet
For each patient the number of videos to be sent each week was specified 5 as default option
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None