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Virtual Observed Therapy for Patients With Tuberculosis

Primary Purpose

Tuberculosis

Status

Completed

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Virtual observed therapy

About this trial

This is an interventional health services research trial for Tuberculosis focused on measuring Tuberculosis, Management, Observed therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Royal Infirmary of Edinburgh

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Virtual Observed Therapy

Arm Description

Intervention = Virtual observed therapy of participants taking TB therapy

Outcomes

Primary Outcome Measures

Treatment completion rates using VOT compared with historical completion rates.

Secondary Outcome Measures

% Cure from TB treatment

number of VOT actually observed divided by the expected VOT observed

patient satisfaction questionnaire at end of treatment

Mortality

Full Information

NCT ID

NCT02680470

First Posted

January 28, 2016

Last Updated

May 5, 2017

Sponsor

University of Edinburgh

Collaborators

NHS Lothian

1. Study Identification

Unique Protocol Identification Number

NCT02680470

Brief Title

Virtual Observed Therapy for Patients With Tuberculosis

Official Title

Virtual Observed Therapy for Patients With Tuberculosis

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Completed

Study Start Date

August 2015 (undefined)

Primary Completion Date

May 2017 (Actual)

Study Completion Date

May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Edinburgh

Collaborators

NHS Lothian

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tuberculosis

Keywords

Tuberculosis, Management, Observed therapy

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Virtual Observed Therapy

Arm Type

Experimental

Arm Description

Intervention = Virtual observed therapy of participants taking TB therapy

Intervention Type

Device

Intervention Name(s)

Virtual observed therapy

Intervention Description

Virtual Observation of participants taking their medication

Primary Outcome Measure Information:

Title

Treatment completion rates using VOT compared with historical completion rates.

Time Frame