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临床试验/NCT04008134
NCT04008134已完成不适用

CHoBI7 Trial: A Hospital Based Water, Sanitation and Hygiene Intervention for Households of Diarrheal Patients in Bangladesh

Johns Hopkins Bloomberg School of Public Health0 个研究点目标入组 2,626 人开始时间: 2016年12月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
2,626
主要终点
Diarrhea prevalence among children under 5 years of age

研究概览

简要总结

The Cholera Hospital Based Intervention for 7 Days (CHoBI7) randomized controlled trial for transition to scale aimed to: (1) Develop and evaluate scalable approaches to integrate the CHoBI7 intervention into the services provided for hospitalized diarrhea patients at health facilities in Bangladesh; and (2) Evaluate the ability of the CHoBI7 intervention to lead to a sustained uptake of the promoted hand washing with soap and water treatment behaviors and significant reductions in diarrheal disease over time.

详细描述

The findings from the recent randomized controlled trial of The Cholera Hospital Based Intervention for 7 Days (CHoBI7) demonstrated that this intervention was effective in significantly reducing symptomatic cholera infections in intervention households, and had significant sustained impacts on hand washing with soap behaviors and improved water quality 12 months post intervention. Next steps to transition to scale were: (1) Develop and evaluate scalable approaches to integrate the CHoBI7 intervention into the services provided for hospitalized diarrhea patients at health facilities in Bangladesh; and (2) Evaluate the ability of the CHoBI7 intervention to lead to a sustained uptake of the promoted hand washing with soap and water treatment behaviors and significant reductions in diarrheal disease over time.

研究设计

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

盲法说明

Masking was not possible because the intervention included visible components including a handwashing station and a covered drinking water storage vessel.

入排标准

性别
All
接受健康志愿者
是

入选标准

  • •Diarrhea patients will be defined as patients having acute watery diarrhea three or more loose stools over a 24-hour period in the past three days. Diarrhea patients admitted to ICDDRB Dhaka Hospital or Mugda General Hospital will be eligible for the trial if:
  • •have had 3 or more loose stools over the past 24 hours
  • •plan to reside in Dhaka for the next 12 months
  • •have no basin for running water in their home
  • •have a child under five years of age in their household (including themselves) that produced a stool sample at baseline
  • •have a working mobile phone in the household.
  • •Household members of the diarrhea patient will be eligible for the trial if:
  • •they have shared the same cooking pot and resided in the same home with the diarrhea patient for the last three days
  • •plan to reside in their current household with the diarrhea patient for the next 12 months

排除标准

  • •(1) Children in foster care will be excluded from all research study activities.

研究组 & 干预措施

Standard recommendation (ORS)

No Intervention

Participants received the standard recommendation on oral rehydration solution use

mHealth with no home visits

Experimental

Participants received the health facility delivery of CHoBI7, plus bi-weekly mHealth (voice and text) reminders for 12 months

干预措施: CHoBI7 health facility program (Behavioral)

mHealth with no home visits

Experimental

Participants received the health facility delivery of CHoBI7, plus bi-weekly mHealth (voice and text) reminders for 12 months

干预措施: CHoBI7 mHealth program (Behavioral)

mHealth with home visits

Experimental

Participants received the health facility delivery of CHoBI7, plus two home visits and bi-weekly mHealth (voice and text) reminders for 12 months

干预措施: CHoBI7 health facility program (Behavioral)

mHealth with home visits

Experimental

Participants received the health facility delivery of CHoBI7, plus two home visits and bi-weekly mHealth (voice and text) reminders for 12 months

干预措施: CHoBI7 mHealth program (Behavioral)

mHealth with home visits

Experimental

Participants received the health facility delivery of CHoBI7, plus two home visits and bi-weekly mHealth (voice and text) reminders for 12 months

干预措施: CHoBI7 home visit program (Behavioral)

结局指标

主要结局

Diarrhea prevalence among children under 5 years of age

时间窗: 12 months

Diarrhea prevalence among children under 5 years of age assessed by caregiver self report over a 12-month period

Diarrhea prevalence among children under 2 years of age

时间窗: 12 months

Diarrhea prevalence among children under 2 years of age assessed by caregiver self report over a 12-month period

Diarrhea prevalence among all household members

时间窗: 12 months

Diarrhea prevalence among all household members assessed by self report over a 12-month period

次要结局

  • Diarrhea prevalence among participants ages 10-18 years(12 months)
  • Handwashing with soap(12 months)
  • Diarrhea prevalence among participants ages greater than 18 years(12 months)
  • Household drinking water treatment(12 months)
  • Height-for-age among children under 2 years of age(12 months)
  • Height-for-age among children under 5 years of age(12 months)
  • Weight-for-height among children under 2 years of age(12 months)
  • Weight-for-age among children under 5 years of age(12 months)
  • Weight-for-height among children under 5 years of age(12 months)
  • Diarrhea prevalence among participants ages 5-9 years(12 months)
  • Weight-for-age among children under 2 years of age(12 months)

研究者

申办方类型
Other
责任方
Sponsor

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