Evaluation of Home-Based Management of Fever in Urban Ugandan Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 540
- 主要终点
- The primary outcome measurement will be treatment incidence density (antimalarial treatments received per time at risk) for each study arm.
研究概览
简要总结
The purpose of this study is to see if providing effective antimalarial treatment at home for parents/guardians to treat their children for malaria will lead to an improved health outcome compared to conventional healthcare.
详细描述
Population: Representative sample of Ugandan children aged 1 to 5 years from 400 households (approximately 540 children).
Clinical Site: The study will be conducted in the Mulago III parish community of Kampala, Uganda.
Study Duration: 13 months
Study Intervention: *Pilot period: After enrollment, households will participate in a one month pilot period to test the household pictorial diaries. At the end of the pilot period, households will be randomized to participation in the home-based management of fever (HBMF) arm or standard care arm for the remainder of the study (12 months). *HBMF arm: Households randomized to the HBMF group will be provided with pre-packaged coartemether to keep at home. Primary caregivers will be instructed to treat children participating in the study empirically with coartemether at home when the child develops fever. Study personnel will distribute drugs and educate the caregivers about administration of drugs, recognition of danger signs of fever/malaria, and when to seek additional care. *Standard care: Households randomized to the standard care arm will be asked to continue their current behaviour and to manage fever in their children as they would normally.
Measurements: Household diaries and monthly visits. Primary caregivers will be asked to keep a diary regarding the health of study participants for the duration of the study (13 months). Information on illnesses, treatments given, visits to health care facilities, and health care expenditures will be collected. Study personnel will visit the households monthly to collect completed diaries. At each visit, questionnaires will be administered to gather additional data on the health of the participants and treatment seeking behaviour.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 1 - 5 years
- •Agreement of parents or guardians to provide informed consent
- •Live in Mulago III Parish
排除标准
- •History of any known serious chronic disease requiring frequent medical care (e.g. AIDS, sickle cell disease, malignancy)
- •Intention to move from Kampala during the 13 month follow-up period
- •History of serious side effects to study medications
- •Weight < 10 kg
- •Severe malnutrition defined as a weight-for-height or height-for-age Z-score < - 3
结局指标
主要结局
The primary outcome measurement will be treatment incidence density (antimalarial treatments received per time at risk) for each study arm.
次要结局
- Mortality rate
- Economic outcomes
- Mean days of fever per participant
- Incidence of visits to health care facilities (drug shops, clinics, pharmacies, hospitals) and hospitalizations per participant
- Incidence of febrile episodes
- Mean haemoglobin at study end
- Change in mean haemoglobin between the start and end of the intervention
研究者
Brian Greenwood
Professor
London School of Hygiene and Tropical Medicine