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临床试验/NCT02763345
NCT02763345已完成不适用

The Added Value of a Mobile Application of Community Case Management on Under-5 Referral, Re-consultation and Hospitalization Rates in Malawi: a Pragmatic Stepped-wedge Cluster Randomized Trial

University of Washington0 个研究点目标入组 6,995 人开始时间: 2016年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
6,995
主要终点
Health worker initiated referral of children to higher-level health facilities

研究概览

简要总结

Community Case Management (CCM) is a clinical decision aid used by frontline Health Surveillance Assistants (HSAs) in Malawi to manage uncomplicated cases of pneumonia and malaria (amongst other conditions). Children identified has having complicated illness are urgently referred to larger health facilities better equipped to clinically manage these more complex presentations. There is evidence to suggest HSAs are missing opportunities to refer seriously ill children, and parents/caregivers are failing to comply with urgent referral recommendations when given; reducing the overall effectiveness of the CCM strategy. Use of mobile technology for deploying CCM has been demonstrated in prior research as feasible to evaluate, acceptable to health workers and parents/caregivers and improving health worker fidelity to the guidelines, but it is unknown if this translates into increased referral and referral completion rates. This trial seeks to evaluate the added value of a purpose developed mobile solution for CCM, called Supporting LIFE electronic Community Case Management (SL eCCM App) on HSA referral and parent/caregiver health seeking behavior.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • Parents/caregivers aged ≥18 years with spoken fluency in Chichewa, Tonga and Tumbuka
  • Children aged ≥2 months to <5 years
  • Able/willing to give voluntary verbal consent

排除标准

  • Parents/caregivers aged <18 years
  • Children aged <2 months or ≥5 years
  • Children who are convulsing or unconscious/unresponsive at presentation
  • Parents/caregivers unable/unwilling to give voluntary verbal consent

结局指标

主要结局

Health worker initiated referral of children to higher-level health facilities

时间窗: at the index visit (study enrollment)

Attendance/non-attendance of parent/caregivers given urgent referral recommendation at higher-level health facilities

时间窗: 7-days post-enrollment

次要结局

  • Acceptability of the SL eCCM App to HSAs and parents/caregivers(<2-weeks post-enrollment)
  • Household-level costs associated with healthcare seeking behavior(< 2-weeks post-enrollment)
  • Barriers and facilitators to parent/caregiver compliance with referral recommendations(<2-weeks post-enrollment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Matthew Thompson

Professor, Department of Family Medicine

University of Washington

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