SMS-based Mobile Health Intervention for Nutritional Status and Treatment Outcomes Among TB Patients in Addis Ababa, Ethiopia: A Cluster Randomized Trial (CRT)
试验速览
- 阶段
- 不适用
- 入组人数
- 440
- 试验地点
- 1
- 主要终点
- Nutritional status change
研究概览
简要总结
Ethiopia is one of the high burden Tuberculosis countries and Tuberculosis is still the leading cause of mortality due to communicable diseases in the country. Nutritional status is one of the predictors of TB treatment outcomes. Thus, the current practices need integration of nutritional intervention in the DOT using Mobile health intervention. However, to investigator's knowledge, there is no sufficient evidence on the effect SMS text Messaging Mobile Health intervention on nutritional status and TB treatment outcomes in Ethiopia.
详细描述
To ensure the quality of SMS intervention, nutritional related SMS text message will be developed systematically through reviewing literature, systematic reviews and guidelines and appropriate behavioral theories by involving experts and patients. Automated SMS will be sent from one computer database at the scheduled date and time. A validated questionnaire will be adapted and pre-tested to check for any error. Adequate sample size is calculated for both arms with the ratio of 1:1 allocation. Standardized Anthropometric measurement, FANTA Household Dietary Diversity Score and WHO TB treatment outcome classification will be used for assessing the outcome variables. The data collectors will be trained on the objective, screening of eligible participants, the procedure of data collection, and how to assure the quality and security of the data based on the protocol. Continuous supervision will be employed throughout the data collection and intervention period. The data will be collected electronically and will be exported to STATA for analysis. Intention to treat analysis and regression analysis model will be employed.
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
- Single (Outcomes Assessor)
盲法说明
Participants and providers will not be blind to the study intervention. Nutrition and tuberculosis treatment outcomes will be assessed by two independent reviewers without knowledge of each participant's treatment allocation.
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
- •Patient who is following their anti TB treatment for at most two weeks and below
- •Patient who have their own mobile phone
- •Patient who is able to read and understand national official language (Amharic)
排除标准
- •Patient whose TB treatment regimen more than 6 months
- •Patient who is pregnant and lactating mothers
- •Patient who enrolled other Interventional research
结局指标
主要结局
Nutritional status change
时间窗: Change from baseline BMI at end of 2 months and 6 months treatment
The nutritional status of the patient will be assessed by Body Mass Index (BMI) that calculated through measuring the body weight and height of the patients using an electronic platform weight scale to the nearest 0.1 kg and height to the nearest centimeter using standardized meter.
次要结局
- Dietary practice change(Change from baseline dietary practice at end of 6 months treatment)
- Treatment outcome(End of six months TB treatment)
研究者
Zekariyas Sahile
PhD candidate
Addis Ababa University