Virtual Observed Therapy for Patients With Tuberculosis | NCT02680470

Studies
Virtual Observed Therapy for Patients With Tuberculosis

NCT02680470

Sponsor

University of Edinburgh

Status

Completed

Last Update Posted

May 8, 2017Actual

Enrollment

12Actual

Phase

Not Applicable

Conditions

Tuberculosis

Interventions

Virtual observed therapy

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2015

Primary Completion Date

May 2017Actual

Completion Date

May 2017Actual

First Submitted Date

Jan 28, 2016

First Submission Date that Met QC Criteria

Feb 8, 2016

First Posted Date

Feb 11, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 5, 2017

Last Update Posted Date

May 8, 2017Actual

Name	Class
NHS Lothian	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Virtual Observed Therapy	Experimental	Intervention = Virtual observed therapy of participants taking TB therapy	Device: Virtual observed therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Virtual observed therapy	Device	Virtual Observation of participants taking their medication	Virtual Observed Therapy

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
% 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)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Royal Infirmary of Edinburgh		Edinburgh		EH16 4SA	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014376	Tuberculosis

Ancestor Terms

ID	Term
D009164	Mycobacterium Infections
D000193	Actinomycetales Infections
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections

Browse Leaves

Not provided

Browse Branches

Not provided