Virtual Observed Therapy for Patients With Tuberculosis

Not Applicable

Completed

• Conditions: Tuberculosis
• Interventions: Device: Virtual observed therapy

• Registration Number: NCT02680470
• Lead Sponsor: University of Edinburgh

Brief Summary

Using modern technology, investigators will observe participants taking their TB tablets three times per week using a mobile phone, iPod or computer with camera facilities in the participants home environment.

Detailed Description

Using modern technology, the investigators will observe participants taking their TB tablets three times per week using a mobile phone, iPod or computer with camera facilities in the participants home environment.

Investigators will connect to the participants mobile phone, iPod or computer at a mutually convenient time three times per week who will observe participants taking their TB medication.

The Virtual Observed Therapy will be carried out using NHS Lothian approved software (mobile app called POLYCOM) three times per week. This is software similar to Skype but POLYCOM is the approved software we use in NHS Lothian.

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2016-01-28
• Study First Submitted QC: 2016-02-08
• Study First Posted: 2016-02-11
• Status Verified: 2017-05
• Primary Completion: 2017-05
• Study Completion: 2017-05
• Last Update Submitted: 2017-05-05
• Last Update Posted: 2017-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Any patient requiring Tuberculosis treatment

Exclusion Criteria

Those refusing consent; the healthcare professional deems the patient that will not be able to comply with VOT

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Virtual Observed Therapy	Virtual observed therapy	Intervention = Virtual observed therapy of participants taking TB therapy

Primary Outcome Measures

Name	Time	Method
Treatment completion rates using VOT compared with historical completion rates.	length of TB treatment (usually 6-12 months)

Secondary Outcome Measures

Name	Time	Method
patient satisfaction questionnaire at end of treatment	length of TB treatment (usually 6-12 months)
% Cure from TB treatment	length of TB treatment (usually 6-12 months)
number of VOT actually observed divided by the expected VOT observed	length of TB treatment (usually 6-12 months)
Mortality	length of TB treatment (usually 6-12 months)

Trial Locations

Locations (1)

Royal Infirmary of Edinburgh; 🇬🇧 Edinburgh, United Kingdom