Clinical trial NCT06574529: Video-observed Therapy for Active Tuberculosis: a Feasibility Study
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tuberculosis Active
Keywords: Compliance
Directly observed therapy
Video-observed therapy
Lead sponsor: Ligue Pulmonaire Genevoise
Sponsor class: OTHER
Collaborators: name: University Hospital, Geneva
First posted: 2024-08-28
Enrollment: 51
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All patients with active tuberculosis were invited to participate in the study and followed during the duration of their treatment until treatment completion
Primary purpose: OTHER

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 site(s) 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 43/year (range: 36-53). Incidence was 7-10.3/105 inhabitants compared to a national incidence of 3.99-4.72 /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 (https://dimagi.com/sureadhere/). 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).

Eligibility criteria: Inclusion Criteria:

* age above 16 years of age; providing informed consent (translators were used whenever necessary to ensure understanding of study and vDOT procedure); having a diagnosis of untreated active tuberculosis, irrespective of site of infection, confirmed by culture and/or Polymerase chain reaction test (PCR) and follow-up ensured by Geneva University Hospital.

Exclusion Criteria:

* refusal to participate, not fulfilling inclusion criteria

Primary outcomes:
measure: Acceptance rate
timeFrame: Two weeks after starting TB treatment
measure: Effective implementation rate
timeFrame: Two weeks after starting TB treatment
Secondary outcomes:
measure: Ratio of number of videos sent to number of videos expected
timeFrame: Duration of treatment (max 12 months)
measure: Quality of videos sent
timeFrame: Duration of treatment (max 12 months)
measure: Evaluation of video-observed therapy by specialized nurses following the patients
timeFrame: End of study (18 months)
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Geneva University Hospital
Study officials:
affiliation: University Hospital, Geneva
name: Jean-Paul Janssens, MD
role: PRINCIPAL_INVESTIGATOR
References: