Innovative Approach in Tuberculosis Care in Armenia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 392
- 试验地点
- 2
- 主要终点
- TB Treatment Success Rates Defined by the World Health Organization (WHO)
研究概览
简要总结
Randomized trial tests effectiveness of self-administered drug intake by empowered TB patients - supervised by a trained family member and supported by medical counseling and reminders - to improve treatment adherence and treatment success rates, and thereby forestall TB and MDR-TB epidemics.
详细描述
The innovative treatment approach integrates several educational, technological, and social evidence-based components. The aim of this study is to pilot the innovative approach for drug-sensitive TB patients during the outpatient phase of tuberculosis treatment. To test the effectiveness of the innovative approach (intervention) a randomized controlled trial with two arms will be conducted. The intervention arm will include drug-sensitive tuberculosis patients that are treated according to the innovative approach, which includes self-administered drug intake supervised by a family member, TB patient and family member training (including distribution of a leaflet about TB) and psychological counseling, reminder text messages to TB patients, and reminder phone call to TB patient family members. The control arm will include drug-sensitive tuberculosis patients that receive the regular Directly Observed Therapy recommended by the World Health Organization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- 否
入选标准
- •Diagnosis of drug-sensitive TB
- •Age 18 years old and above
- •Understanding and reading in Armenian
- •Completion of the intensive treatment phase
排除标准
- •Involvement in the Home Based TB Treatment Program of the National TB Control Office
结局指标
主要结局
TB Treatment Success Rates Defined by the World Health Organization (WHO)
时间窗: Patients were followed for the duration of ambulatory phase of treatment, an average of 4.2 months
The sum of cured (TB patients with bacteriologically confirmed TB at the beginning of treatment who were smear- or culture-negative in the last month of treatment and on at least one previous occasion) and treatment completed (TB patients who completed treatment without evidence of failure but with no record to show that sputum smear or culture results in the last month of treatment and on at least one previous occasion were negative,either because tests were not done or because results are unavailable).
次要结局
- Stigma Level Towards TB Patients(At baseline and upon completion of the treatment (an expected average of 4.5 months after starting the ambulatory phase of the treatment))
- Family Support Towards TB Patients(At baseline and upon completion of the treatment (an expected average of 4.5 months after starting the ambulatory phase of the treatment))
- Knowledge About TB Infection(At baseline and upon completion of the treatment (an expected average of 4.5 months after starting the ambulatory phase of the treatment))
- TB Treatment Adherence(At baseline and upon completion of the treatment (an expected average of 4.5 months after starting the ambulatory phase of the treatment))
- Depression Status of TB Patients(At baseline and upon completion of the treatment (an expected average of 4.5 months after starting the ambulatory phase of the treatment))
- Quality of Life of TB Patients(At baseline and upon completion of the treatment (an expected average of 4.5 months after starting the ambulatory phase of the treatment))
研究者
Varduhi Petrosyan
MS, PHD
American University of Armenia Fund