跳至主要内容
临床试验/NCT06318078
NCT06318078招募中不适用

A Research Study to Understand the Impact and Cost-effectiveness of a Digital Health Platform for iCCM in Uganda

Malaria Consortium1 个研究点 分布在 1 个国家目标入组 1,140 人开始时间: 2023年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
1,140
试验地点
1
主要终点
Hospitalisation (due to malaria, pneumonia and diarrhoea)

研究概览

简要总结

The purpose of the study is to investigate the impact of the eCHIS intervention on key child health outcomes.

详细描述

Following national guidelines, 2 VHTs per village will be supported to provide the full eCHIS community health package. In total 856 VHTs in Buikwe district will have been trained and equipped with the national strategy and operational guidelines on eCHIS as well as the VHT full package (iCCM+ and VHT basic package (reproductive health, immunization, nutrition) guidelines. The VHTs will be equipped with mobile devices and iCCM supplies to start the management of community-based health among children aged five years within their respective communities. A cross-sectional cluster randomized controlled trial (cRCT) will be used to establish study outcomes in children under 5 years in the intervention and control areas using mixed methods (qualitative and quantitative) of data collection.

A total sample size of 1,140 children under five: 570 children under five, per arm, was scientifically determined for the study. During data collection, several quality control measures will be applied to ensure the data recorded reflect the facts, responses, observations, and events. A standard operating procedure (SOP) with roles and responsibilities of the data collectors will be prepared to ensure standardized methods for capturing data. After endline data collection, difference-in-differences (DID) analysis will be done to derive an estimate of the intervention effect on odds of the study outcomes.

Results will be disseminated through agreed peer-review publications and international conferences. Malaria Consortium Uganda will work with relevant stakeholders at the Ministry of Health and Medic Mobile to disseminate findings nationally and throughout the study district.

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
None

入排标准

年龄范围
3 Months 至 59 Months(Child)
性别
All
接受健康志愿者

入选标准

  • · Children between 3-59 months,
  • Being resident in the study area,
  • Consent to participate in the study obtained,
  • Willingness and ability of the child's guardians to comply with the study protocol for the duration of the study including attending a designated health centre if their child has malaria symptoms during the data collection period.

排除标准

  • Children aged below 3 months and above 59 months
  • Children resident outside the study areas
  • Those who have not consented to participate in the study

研究组 & 干预措施

Control

No Intervention

570 children will be allocated to the intervention arm and children in this arm will be assessed using the standard care and paper based tools.

Intervention

Experimental

570 children will be allocated to the intervention arm and children in this arm will be assessed using the eCHIS digital tool.

干预措施: eCHIS (Other)

结局指标

主要结局

Hospitalisation (due to malaria, pneumonia and diarrhoea)

时间窗: Over 1 year

Attendance measured through baseline and endline surveys

malaria related mortality in the community and health facilities

时间窗: Over 1 year

Malaria related mortality measured through routine data

Out Patient Department attendance (due to malaria, pneumonia and diarrhoea)

时间窗: Over 1 year

Attendance measured through baseline and endline surveys

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验