NCT01945905已完成不适用
Cost-effectiveness of Two Forms of Delivery of Directly Observed Treatment in a Demonstration Area of the DOTS Strategy in Colombia
Fundación FES2 个研究点 分布在 1 个国家目标入组 264 人开始时间: 2009年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 264
- 试验地点
- 2
- 主要终点
- Compliance with treatment
研究概览
简要总结
- Tuberculosis ( TB ) remains a major global public health problems and actions to ensure the diagnosis and complete treatment of all cases is the priority for the control of this disease. Despite the availability of effective anti-tuberculosis medications, there are still high levels of nonadherence to treatment. The nonadherence increases the morbidity and mortality of patients, decreases the cure rate, increases the community transmission and the increase of chronically ill patients enables the emergence of multi - drug resistant and increases treatment costs.
- Despite the knowledge about different forms of cost-effective delivery of DOT (directly observed treatment), recognition of the need to establish the DOT strategy related to the context from local studies, in Colombia and in Cali we hadn't had made studies similar than this one that establish the cost and results of the current DOT delivery strategy and to identify other ways to improve adherence and cure rate for the TB patients at reasonable cost for both: health services and families
- Therefore, this research aims to compare the cost -effectiveness of current DOT delivery method with an alternative extra- institutional delivery of anti -TB treatment in urban areas of Cali. A cost-effectiveness study was conducted from the institutional and familiar perspective with prospective information collection.
详细描述
We compared two strategies for anti- TB treatment delivery: one institutional in which patients went to health institutions to receive treatment and other extra- institutional in which the medication was delivered in the place of choice for treating patients.
Measuring the effectiveness ( compliance and cure ) was made from a controlled clinical trial , randomized , partially blinded . The measurement of family and institutional costs , direct and indirect , will be based on the activities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
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
- 是
入选标准
- •Male and female (non-pregnant)
- •15 years of age and older
- •Living in urban area (Cali)
- •New diagnosed patients (TB)
- •In conditions to give survey information
- •Patients without hemoptysis and special conditions like: hepatic disease, renal failure, diabetes, hypertension, HIV/AIDS and negative test for pulmonary tuberculosis
排除标准
- •Not written informed consent
结局指标
主要结局
Compliance with treatment
时间窗: Participants will be followed for the duration of the treatment, an expected average of six months
Total of patients who completed de treatment
次要结局
- Cured patients(Participants will be followed for the duration of the treatment, an expected average of six months)
研究者
Sandra Lorena Girón Vargas
Msc Epidemiologist
Fundación FES
研究点 (2)
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