Monitoring Patient Compliance With Tuberculosis Treatment Regimens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,207
- 试验地点
- 11
- 主要终点
- Treatment Outcomes
研究概览
简要总结
In this study, Interactive Research and Development (IRD) in Karachi, Pakistan is evaluating the impact of Interactive Reminders on drug compliance and treatment outcomes. Interactive Reminders is an interactive SMS reminder system to help patients remember to take their TB medication. In this system, patients receive daily SMS reminders for the duration of their treatment at a pre-specified time, reminding them to take their medication. Patients are asked to reply back to the system, either through SMS or a missed call, with the time they took their medicine that day. If a response is not received within two hours, a second reminder is sent. If a response is still not received in a further two hours, a third and final reminder for the day is sent. Non-responsive patients are followed up with phone calls and a list of non-responsive patients is shared with clinics based on the parameters of non-responsiveness that they specify.
IRD seeks to determine the impact of this system on treatment outcomes and compliance to prescribed medication through administering a randomized control trial among newly diagnosed TB patients in Karachi, Pakistan.
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
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •New, smear-positive drug susceptible TB who have been on treatment for less than two weeks
- •Access to a mobile phone (self-reported)
- •Intending to reside in Karachi for the duration of their treatment
排除标准
- •Patients who do not have regular access to a mobile phone
- •Patients who have previously received TB treatment
- •Patients who have another member in their household who is already a part of the study
结局指标
主要结局
Treatment Outcomes
时间窗: After 6 to 8 months of treatment
The investigators will compare clinically reported treatment outcomes between the intervention and control groups.
次要结局
- Physical fitness and mobility(Monthly visits for 6 to 8 months of treatment)
- Psychological Impacts(Monthly visits for 6 to 8 months of treatment)
- Self-reported medication adherence("Surprise" monthly visits during treatment)
- Sputum conversion(At 1, 2, 5, and 6/7 months of treatment)
研究者
Shama Mohammed
Associate Researcher
Interactive Research and Development