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Video-observed Therapy for Active Tuberculosis: a Feasibility Study

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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06574529
Enrollment
51
Registered
2024-08-28
Start date
2021-11-26
Completion date
2024-05-31
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tuberculosis Active

Keywords

Compliance, Directly observed therapy, Video-observed therapy

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).

Interventions

DEVICEVideo-observed therapy (vDOT)

All participants are required to send 5 times per week a short video showing they are actually taking their treatment for tuberculosis via a dedicated application on their cellphone

Sponsors

University Hospital, Geneva
CollaboratorOTHER
Ligue Pulmonaire Genevoise
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

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

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Acceptance rateTwo weeks after starting TB treatmentNumber of patients accepting to install the application on their cellphone and send videos of their treatment until treatment completion, among all patients initiating a treatment for active tuberculosis in our center
Effective implementation rateTwo weeks after starting TB treatmentNumber of patients for whom installing the application, and learning how to use it was possible among all patients with active TB during study period

Secondary

MeasureTime frameDescription
Ratio of number of videos sent to number of videos expectedDuration of treatment (max 12 months)Number of videos recorded on the secured platform compared with number expected(% x number of weeks of treatment)
Quality of videos sentDuration of treatment (max 12 months)Proportion of videos with technical problems (sound, lighting, framing) was recorded
Evaluation of video-observed therapy by specialized nurses following the patientsEnd of study (18 months)Questionnaire with Likert scales submitted to all nurses at the end of the study

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026