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Field
Last Published
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Before
December 12, 2014 06:40 AM
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After
December 12, 2014 06:45 AM
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Field
Primary Outcomes (End Points)
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Before
For the trial there will be three outcome measures;
1) The number of days per month that each patient fails to adhere to treatment (continuous)
2) If a patient achieves 80% adherence for a given month (binary). This is the target adherence rate used for a forthcoming trial of VOT by the NHS
3) Patient wellbeing. Whether a patient gives a positive response about their treatment on a likert scale (binary).
Adherence is regularly recorded on patient TB-01 record sheets at TB cabinets. The time dimension of this data will give us additional power to detect results. The trial will run for one year, collecting nine months of adherence data collected for each patient every month. Trial duration is longer than data collection for each patient since patients are recorded from the start of their continuation phase, and different patients will be starting at different times. The patient wellbeing questionnaire will be conducted during the ninth month. Additionally this questionnaire will include questions on the cost of patient travel in order to quantify the money by patients receiving VOT.
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After
The primary outcome measure for the trial will be the number of days per two week period that each patient fails to adhere to treatment (continuous). Only patients that are observed will be counted. This will be collected continuously through observation.
There will be a number of secondary outcome measures:
1) Proportion of patients having more than 80% of scheduled medication sessions (binary) observed in participants with a minimum of 6 weeks follow up data. This is the target adherence rate used for a forthcoming trial of VOT by the NHS in the UK.
2) Patient wellbeing – self reported using a short form version (5 questions) of the WEMWBS questionnaire for measuring mental wellbeing was developed by researchers at Warwick and Edinburgh Universities – collected at baseline and at 4 months
3) Patient satisfaction. Whether a patient gives a positive response about their treatment on a likert scale (binary) – collected at baseline and at 4 months.
4) Travel and time cost of treatment borne by patient, (self reported, continuous) – collected at 4 months.
5) Employment (binary) – collected at baseline and at 4 months.
6) Treatment success (binary) – collected at 4 months.
7) Body mass index (BMI) (continuous) – collected at baseline and at 4 months.
8) Side effects (self-reported, categorical) - collected at baseline and at 4 months.
We will also conduct a number of qualitative interviews with patients, non-randomly selecting a range of people and levels of adherence.
Adherence is regularly recorded on patient TB-01 record sheets at TB polyclinics. The time dimension of this data will give us additional power to detect results for the primary outcome measure. The trial will collect four months of adherence data for each patient. Trial duration is longer than data collection for each patient since patients will be starting their continuation phase treatment at different times. The patient wellbeing questionnaire will be conducted during the fourth month of treatment in the ambulatory phase for each patient. Additionally this questionnaire will include questions on the time and cost of patient travel to their polyclinic in order to quantify the money saved by patients receiving VOT.
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Experimental Design (Public)
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Before
VOT will initially be trialled on TB patients in the continuation phase with access to Skype in their home. The trial will work as a consent-randomise model. Initially the universe of MDR-TB patients in the intensive phase in Chisinau will be given a short questionnaire. The baseline patient questionnaire will include questions on patient characteristics, and whether patients would consent to being part of a trial of VOT for their treatment in the continuation phase . From the results of this questionnaire all patients that consent to be a part of the trial and are authorised by the relevant medical officials will be eligible to be a part of the trial .
The first 194 TB patients to consent to trial VOT will form our sample. Out of these 188 patients, 94 will be randomly chosen to form the treatment group. These 94 will all be observed from one VOT centre set up in one polyclinic. The 94 patients that from the control group will be sent to one of the 13 other TB polyclinics in Chisinau for the normal DOT treatment regimen.
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After
The trial will work as a consent-randomise individually randomised trial. Initially patients in the intensive phase in Chisinau will be questioned in order to determine their eligibility to take part in the trial based on certain criteria. Patients that meet the criteria will then be given information on the trial and decide whether they want to participate. Those that meet the eligibility criteria and give consent will be randomised into receiving VOT or DOT.
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Randomization Method
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Before
Randomisation will be conducted at the individual level. Once the list of 188 potential participants is compiled, each patient will be randomly assigned to a control group (n = 94) or the treatment arm (n = 94). An online randomisation tool will be set up for the implementing partner.
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After
As per above participant selection timeline randomisation will be conducted on a web based platform developed by BIT. Patients will be randomly assigned to the control group (DOT) or the treatment arm (VOT) with a 50% chance of being in each group. An on-line randomisation tool will be set up for the implementing partner.
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Sample size (or number of clusters) by treatment arms
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Before
188 Individuals
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After
200 Individuals
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