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

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.

Study Overview

• Status: Completed
• Conditions: Tuberculosis Active
• Intervention / Treatment: Device: Video-observed therapy (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).

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Canton of Geneva
    • Geneva, Canton of Geneva, Switzerland, 1205
      • Geneva University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study group; The study is not randomised; all subjects included are submitted to the VOT	Device: Video-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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptance rate	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	Two weeks after starting TB treatment
Effective implementation rate	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	Two weeks after starting TB treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ratio of number of videos sent to number of videos expected	Number of videos recorded on the secured platform compared with number expected(% x number of weeks of treatment)	Duration of treatment (max 12 months)
Quality of videos sent	Proportion of videos with technical problems (sound, lighting, framing) was recorded	Duration of treatment (max 12 months)
Evaluation of video-observed therapy by specialized nurses following the patients	Questionnaire with Likert scales submitted to all nurses at the end of the study	End of study (18 months)

Collaborators and Investigators

• Sponsor: Ligue Pulmonaire Genevoise
• Collaborators: University Hospital, Geneva
• Investigators: Principal Investigator: Jean-Paul Janssens, MD, University Hospital, Geneva

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2021
• Primary Completion (Actual): July 18, 2023
• Study Completion (Actual): May 31, 2024

Study Registration Dates

• First Submitted: August 25, 2024
• First Submitted That Met QC Criteria: August 25, 2024
• First Posted (Actual): August 28, 2024

Study Record Updates

• Last Update Posted (Estimated): September 8, 2025
• Last Update Submitted That Met QC Criteria: September 1, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Compliance; Directly observed therapy; Video-observed therapy
• Additional Relevant MeSH Terms: Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Actinomycetales Infections; Mycobacterium Infections; Behavior; Treatment Adherence and Compliance; Health Behavior; Patient Acceptance of Health Care; Medication Adherence; Tuberculosis; Patient Compliance; Directly Observed Therapy
• Other Study ID Numbers: CCER 2021-01713

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No