Tuberculosis Clinical Trial
This trial aims to increase the wellbeing of tuberculosis patients and their adherence to
medication in Chisinau, The Republic of Moldova. The design is an individually randomised
controlled trial (RCT) and will involve 400 TB patients during their 'continuation phase' of
treatment. The trial will have two arms; 200 patients will form the control group and
receive the standard provision of Directly Observed Treatment (DOT) and 200 will receive
Virtually Observed Treatment (VOT).
VOT differs from DOT in that the daily observation of patients taking their medication will
be observed via internet video messages rather than in-person. Based on a small sample of
patient interviews we think that for some patients DOT may be a hindrance rather than a
help. VOT allows patients to take their treatment in the comfort of their home and means
they don't have to travel to their polyclinic every day.
There will be a central VOT observation centre where VOT observers will view and respond to
video messages sent in by patients in the VOT arm. The messages will be sent via an M-Health
app. The VOT observers will also respond to the patients by sending feedback to the
patients. The trial duration will depend on the recruitment rate of eligible patients but is
expected to take 16 months.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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