Intervention Study to Improve Maternal Handwashing
2022年9月22日 更新者:State University of New York at Buffalo
Effects of Promoting Handwashing With Soap to Improve Maternal Handwashing Behavior During the Neonatal Period
The purpose of the handwashing intervention trial is to determine whether an interactive, storytelling approach to promoting handwashing with soap by health care workers can improve mothers' handwashing behavior during the first month of her child's life.
研究概览
详细说明
Infectious diseases, such as umbilical cord infection, pneumonia, and sepsis, are responsible for about a quarter of neonatal deaths.
Contaminated hands likely play a role in transmitting pathogens to a neonate, therefore handwashing with soap has the potential to interrupt transmission and improve neonatal health.
The primary objective of this study is to develop and evaluate a scalable, cost-effective handwashing promotion program to improve handwashing behavior among mothers and caregivers of neonates.
The investigators will first conduct a qualitative study to assess the feasibility and acceptability of a set of interventions.
The investigators propose to evaluate the impact of the intervention components, designed as three progressively intense interventions, using a randomized controlled trial with elements of a stepped wedge design.
The study will be conducted in Meru County, Kenya, enrolling a total of 800 pregnant women who seek non-emergency antenatal care at a government health facility during a 1 year period.
Clinic based health care workers and community health volunteers will disseminate the intervention using an interactive storytelling approach.
The focus of the interactions between the health care workers and volunteers and the participant will be on addressing barriers to handwashing through interactive question and answer sessions, rather than a didactic, educational session.
The investigators will assess the impact of interventions on observed maternal and caregiver handwashing behavior and estimate the cost effectiveness for each intervention.
研究类型
介入性
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Meru County
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Igembe North And Igembe South Subcounties、Meru County、肯尼亚
- Government funded antenatal care clinics
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
不
有资格学习的性别
女性
描述
Inclusion Criteria:
- Pregnant women
- Seeking routine (non-emergency) care at a participating antenatal care clinic during the study period
- Between 30 and 36 weeks pregnant (calculated based on last known menstrual period) when they seek antenatal care
- Live within 30 minutes or 1-2 km one-way travel from the clinic
- Plan to remain in the study area for at least one month post-partum
- Willing to allow the field worker to visit her home following the antenatal care visit on the day of enrollment to conduct baseline assessments at the household
- Sought antenatal care from a qualified medical provider for the first time at or after 28 weeks gestation
Exclusion Criteria:
- Excluded if another member of their household or compound/homestead enrolled in this study
- Excluded if enrolled in the formative research for this study
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预:Control
Women will receive standard antenatal care but will not receive any additional handwashing promotion, soap, or handwashing device during their enrollment.
At the end of data collection, handwashing with soap will be recommended to participants in the control arm and their families.
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实验性的:Clinic
Handwashing promotion from healthcare workers at antenatal care clinic.
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Pregnant women will receive handwashing promotion from a trained facility-based health care worker during her regular antenatal visit at a healthcare clinic.
To the extent feasible, everyone accompanying the pregnant woman will be invited to take part in the behavior change communication session.
The participant will be provided with several bars of soap to take home and she will be encouraged to maintain a designated place for washing hands (with soap and water) at the home.
A poster indicating the key events for handwashing with soap will be posted at the clinic and smaller posters will be given to the participant to post in her home.
A system will be established to send regular SMS messages to the participant promote handwashing with soap during the neonatal period.
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实验性的:Clinic + home
Handwashing promotion from healthcare workers at antenatal care clinic and from community health volunteers at home visits.
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Women will receive all components of the clinic-based handwashing promotion in addition to handwashing promotion during 3-4 home visits before their expected delivery date and during the neonatal period from a community health volunteer.
All household members present will be invited to join in the session, with emphasis on including all caregivers of the neonate.
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实验性的:Clinic + home + handwashing device
Handwashing promotion from healthcare workers at antenatal care clinic and from community health volunteers at home visits with provision of one handwashing device.
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Women will receive all components of the clinic + home-based handwashing promotion intervention in addition to one handwashing device (i.e.
tap and basin to use as a handwashing station) during the first home visit by the community health volunteer.
The community health volunteer will work with the woman and her family to identify the location where the neonate will be most of the time in order to position the handwashing station as close to the neonate as possible.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Frequency of washing hands with soap at potential pathogen transmission events by mothers of neonate
大体时间:1 week post-natal
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Direct observation of handwashing behavior of mothers at times when pathogens may be transmitted from the mother to the neonate
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1 week post-natal
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Frequency of washing hands with soap at potential pathogen transmission events by mothers of neonate
大体时间:2 weeks post-natal
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Direct observation of handwashing behavior of mothers at times when pathogens may be transmitted from the mother to the neonate
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2 weeks post-natal
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Frequency of washing hands with soap at potential pathogen transmission events by caregivers of neonate (other than mother)
大体时间:1 week post-natal
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Direct observation of handwashing behavior of caregivers (other than mother) at times when pathogens may be transmitted from the caregiver to the neonate
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1 week post-natal
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Number of participants with soap and water present at a handwashing station
大体时间:1 week post-natal
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Observed presence of soap and/or water at a handwashing station
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1 week post-natal
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Cost-effectiveness
大体时间:1 month post-partum
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Approximate cost of the intervention per participant
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1 month post-partum
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Frequency of washing hands with soap at potential pathogen transmission events by caregivers of neonate (other than mother)
大体时间:2 weeks post-natal
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Direct observation of handwashing behavior of caregivers (other than mother) at times when pathogens may be transmitted from the caregiver to the neonate
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2 weeks post-natal
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Number of participants with soap and water present at a handwashing station
大体时间:2 weeks post-natal
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Observed presence of soap and/or water at a handwashing station
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2 weeks post-natal
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Pavani K. Ram, M.D.、State University of New York at Buffalo
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (预期的)
2016年2月1日
初级完成 (预期的)
2016年12月1日
研究完成 (预期的)
2018年8月1日
研究注册日期
首次提交
2016年1月13日
首先提交符合 QC 标准的
2016年5月3日
首次发布 (估计)
2016年5月6日
研究记录更新
最后更新发布 (实际的)
2022年9月23日
上次提交的符合 QC 标准的更新
2022年9月22日
最后验证
2017年10月1日
更多信息
与本研究相关的术语
关键字
其他研究编号
- 748140-1
- ESRC P176/2015 (其他标识符:Amref)
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研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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