Virtually Observed Treatment (VOT) for Tuberculosis Patients in Moldova
NCT ID: NCT02331732
Last Updated: 2015-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
400 participants
INTERVENTIONAL
2015-10-31
2017-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Control
Patients receive DOT as normal - involves patient going to polyclinic to be observed taking treatment every day
Directly Observed Treatment
Treatment
Patients receive VOT - involves patient sending a video of themselves taking their treatment over M-health app which will be reviewed remotely by observers
Virtually Observed Treatment
Interventions
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Virtually Observed Treatment
Directly Observed Treatment
Eligibility Criteria
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Inclusion Criteria
2. Live in Chisinau and no plans to move away from Chisinau during the four months
3. Aged 18 or over
4. At least four months of care remaining
Exclusion Criteria
2. Homeless
3. Is not homeless
4. Suffer from alcoholism or drug misuse
5. In prison
6. Has a treatment regimen with injections
18 Years
ALL
Yes
Sponsors
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The Behavioural Insights Team
OTHER
Responsible Party
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Central Contacts
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References
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Ravenscroft L, Kettle S, Persian R, Ruda S, Severin L, Doltu S, Schenck B, Loewenstein G. Video-observed therapy and medication adherence for tuberculosis patients: randomised controlled trial in Moldova. Eur Respir J. 2020 Aug 6;56(2):2000493. doi: 10.1183/13993003.00493-2020. Print 2020 Aug.
Other Identifiers
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201405*
Identifier Type: -
Identifier Source: org_study_id
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