Virtual Observed Therapy for Patients with Tuberculosis

  • Research type

    Research Study

  • Full title

    Virtual Observed Therapy for Patients with Tuberculosis

  • IRAS ID

    164837

  • Contact name

    Adam T Hill

  • Contact email

    adam.hill318@nhs.net

  • Sponsor organisation

    NHS Lothian

  • Clinicaltrials.gov Identifier

    NCT02680470

  • Duration of Study in the UK

    2 years, 0 months, 0 days

  • Research summary

    This is a proof of concept study to determine whether Virtual Observed Therapy (VOT)is feasible, acceptable to patients and health care professionals and will lead to >85% TB treatment completion rates for latent and active TB.

    The background to this is that in Lothian the treatment completion rate in 2012 was 73.9% against the European Centre for Disease Prevention and Control standards (>85% for drug sensitive TB and >70% for drug resistant TB). We have <1% multi drug resistant TB in Lothian so we should be hitting targets >85%. VOT will allow all latent and active TB to have their treatment monitored and the hypothesis is that hopefully this will improve treatment completion rates compared to historical data from previous years.

    Using modern technology, we would like to observe TB patients taking their TB tablets three times per week using a mobile phone, iPod or computer with camera facilities in the patients own home environment. Our nurses will connect to the patient’s mobile phone, iPod or computer at a mutually convenient time three times per week who will observe the patient taking their TB medication.

    On the four other days, we will ask the TB patient to video themselves on the mobile phone, iPod or computer taking their TB medication and showing the nurses the video clips when the nurse next observes them 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.

    All that will be recorded in the notes related to the study is whether the consult took place and the tablets were taken.

    We will ask the patient to fill in a short satisfaction questionnaire at the end of the study.

    We will monitor
    a} treatment response at the end of latent and active TB treatment (treatment completion rate; cure from active TB treatment; mortality)
    b} number of VOT actually observed divided by the expected VOT observed
    c} patient satisfaction questionnaire at end of treatment

  • REC name

    West of Scotland REC 1

  • REC reference

    15/WS/0004

  • Date of REC Opinion

    20 Jan 2015

  • REC opinion

    Further Information Favourable Opinion