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NCT Number: NCT06574529

Video-observed Therapy for Active Tuberculosis: a Feasibility Study

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.

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Key information

Conditions

Tuberculosis Active Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Behavior Directly Observed Therapy Gram-Positive Bacterial Infections Health Behavior Infections Medication Adherence Mycobacterium Infections Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance Tuberculosis

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Geneva University Hospital

Geneva, Canton of Geneva, 1205, Switzerland

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Video-observed therapy (vDOT)

Device

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

Primary outcomes

  1. Acceptance rate

    Time frame: Two weeks after starting TB treatment

    Number 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

  2. Effective implementation rate

    Time frame: Two weeks after starting TB treatment

    Number 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 outcomes

  1. Ratio of number of videos sent to number of videos expected

    Time frame: Duration of treatment (max 12 months)

    Number of videos recorded on the secured platform compared with number expected(% x number of weeks of treatment)

  2. Quality of videos sent

    Time frame: Duration of treatment (max 12 months)

    Proportion of videos with technical problems (sound, lighting, framing) was recorded

  3. Evaluation of video-observed therapy by specialized nurses following the patients

    Time frame: End of study (18 months)

    Questionnaire with Likert scales submitted to all nurses at the end of the study

Sponsors and collaborators

Lead sponsor

Ligue Pulmonaire Genevoise

Other

Collaborators

  • University Hospital, Geneva

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Aug 28, 2024
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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