NCT02680470

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 11, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

May 8, 2017

Status Verified

May 1, 2017

Enrollment Period

1.8 years

First QC Date

January 28, 2016

Last Update Submit

May 5, 2017

Conditions

Tuberculosis

Keywords

TuberculosisManagementObserved therapy

Outcome Measures

Primary Outcomes (1)

  • Treatment completion rates using VOT compared with historical completion rates.

    length of TB treatment (usually 6-12 months)

Secondary Outcomes (4)

  • % 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)

  • patient satisfaction questionnaire at end of treatment

    length of TB treatment (usually 6-12 months)

  • Mortality

    length of TB treatment (usually 6-12 months)

Study Arms (1)

Virtual Observed Therapy

EXPERIMENTAL

Intervention = Virtual observed therapy of participants taking TB therapy

Device: Virtual observed therapy

Interventions

Virtual observed therapyDEVICE

Virtual Observation of participants taking their medication

Virtual Observed Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any patient requiring Tuberculosis treatment

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Infirmary of Edinburgh

Edinburgh, EH16 4SA, United Kingdom

Location

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Design

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

Study Record Dates

First Submitted

January 28, 2016

First Posted

February 11, 2016

Study Start

August 1, 2015

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

May 8, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)