Video-observed Therapy for Active Tuberculosis: a Feasibility Study

NCT06574529 | Completed

• 1 other identifier: CCER 2021-01713
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Tuberculosis Active

Keywords

Compliance; Directly observed therapy; Video-observed therapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Ratio of number of videos sent to number of videos expected

  Duration of treatment (max 12 months)

• Quality of videos sent

  Duration of treatment (max 12 months)

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

  End of study (18 months)

Study Arms (1)

Study group

EXPERIMENTAL

The study is not randomised; all subjects included are submitted to the VOT

Device: Video-observed therapy (vDOT)

Interventions

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

Study group

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Ligue Pulmonaire Genevoise: lead
• University Hospital, Geneva: collaborator

Study Sites (1)

Geneva University Hospital

Geneva, Canton of Geneva, 1205, Switzerland

Location

MeSH Terms

Conditions

Tuberculosis; Patient Compliance; Directly Observed Therapy

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Medication Adherence

Study Officials

• Jean-Paul Janssens, MD

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All patients with active tuberculosis were invited to participate in the study and followed during the duration of their treatment until treatment completion

Study Record Dates

• First Submitted: August 25, 2024
• First Posted: August 28, 2024
• Study Start: November 26, 2021
• Primary Completion: July 18, 2023
• Study Completion: May 31, 2024
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)