Virtually Observed Treatment (VOT) for Tuberculosis Patients in Moldova
试验速览
- 阶段
- 不适用
- 入组人数
- 400
- 主要终点
- Adherence to medication
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Consent to being part of the trial
- •Live in Chisinau and no plans to move away from Chisinau during the four months
- •Aged 18 or over
- •At least four months of care remaining
排除标准
- •Having MDR-TB
- •Is not homeless
- •Suffer from alcoholism or drug misuse
- •Has a treatment regimen with injections
结局指标
主要结局
Adherence to medication
时间窗: 2 weeks
Number of days per two week period that each patient fails to adhere to treatment, continuous. Panel data collected from TB-01 record sheets for duration of patient continuation phase of treatment - on average 5 months
次要结局
- Patient wellbeing(Collected at 4 months)
- Employment, self reported(Collected at 4 months)
- Patient satisfaction(Collected at 4 months)
- Side effects reported during treatment(Collected at 4 months)
- Adherence 80%(2 weeks)
- Travel and time cost of treatment borne by patient, self reported.(Collected at 4 months)
- Treatment success(Collected at 4 months)
- Body mass index (BMI)(Collected at 4 months)