Virtual Observed Therapy for Patients With Tuberculosis

Tuberculosis Clinical Trial

Official title:

Virtual Observed Therapy for Patients With Tuberculosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02680470
• Other study ID #: 15/WS/0004
• Status: Completed
• Phase: N/A
• First received: January 28, 2016
• Last updated: May 5, 2017
• Start date: August 2015
• Est. completion date: May 2017

Study information

• Verified date: May 2017
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tuberculosis

Intervention

Device:
• Virtual observed therapy
Virtual Observation of participants taking their medication

Locations

Country	Name	City	State
United Kingdom	Royal Infirmary of Edinburgh	Edinburgh

Sponsors (2)

Lead Sponsor	Collaborator
University of Edinburgh	NHS Lothian

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment completion rates using VOT compared with historical completion rates.		length of TB treatment (usually 6-12 months)
Secondary	% Cure from TB treatment		length of TB treatment (usually 6-12 months)
Secondary	number of VOT actually observed divided by the expected VOT observed		length of TB treatment (usually 6-12 months)
Secondary	patient satisfaction questionnaire at end of treatment		length of TB treatment (usually 6-12 months)
Secondary	Mortality		length of TB treatment (usually 6-12 months)