Mobile WACh NEO Randomized Clinical Trial: Mobile Phone 2-Way Short Message Service (SMS) Versus Control to Reduce Neonatal Mortality in Kenya
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5,020
- 试验地点
- 6
- 主要终点
- Neonatal Mortality
研究概览
简要总结
To improve neonatal mortality, it is critical to engage families, especially mothers, in essential newborn care (ENC) and appropriate care-seeking for neonatal illness as well as to support maternal mental health and self-efficacy. This randomized controlled trial (RCT) aims to determine the effect and mechanisms of a two- way mobile health (mHealth) SMS intervention, Mobile WACh NEO, on neonatal mortality, essential newborn practices, care-seeking and maternal mental health at four sites in Kenya.
详细描述
High-impact essential newborn care practices and interventions are available to support neonatal survival, but coverage remains a challenge in sub-Saharan Africa, where neonatal mortality is unacceptably high. Many newborns continue to die at home without health care services being sought. The reasons are multifactorial, at the societal, health system, and family levels. Decisions made within the household and the family's ability to reach care play a large part in determining neonatal outcomes. It is estimated that up to 80% of neonatal and child deaths may have delays in recognition of infant illness and decision to seek care. Two-way mobile health (mHealth) communication strategies can enable mothers to remotely interact with a healthcare worker (HCW) and receive real-time education, counseling, encouragement, motivation and decisional guidance to support care-seeking decisions and ultimately neonatal health and survival.
The investigators developed a unique two-way SMS platform (Mobile WACh) that combines automated SMS messaging and dialogue with a HCW. The team adapted this approach for intensive neonatal support and evaluations (Mobile WACh NEO). Mobile WACh NEO (MWN) enhances the benefits of SMS messaging by engaging mothers with SMS communication and bringing timely information and support - asking critical questions at crucial times in order to assess the needs and health of newborns and assist in care seeking decisions.
This is a randomized controlled trial of the MWN intervention among 5,020 participants (2,510 MWN arm, 2,510 control arm) to determine the effect of MWN on neonatal mortality, essential newborn care, care seeking, and maternal mental health in the first 6 weeks postpartum.
Aim 1: To determine the effect of Mobile WACh NEO on neonatal mortality, compared to no SMS control.
Aim 2: To examine the effect of Mobile WACh NEO on maternal implementation of essential newborn care and care 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
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •28-36 weeks gestation
- •Daily access to a mobile phone (own or shared) on the Safaricom network
- •Willing to receive SMS
- •Able to read and respond to text messages in English, Kiswahili or Luo, or have someone in the household who can help
排除标准
- •Currently enrolled in another research study
- •Previous participant in the Mobile WACh NEO RCT (i.e. with a new pregnancy)
结局指标
主要结局
Neonatal Mortality
时间窗: 28 days postpartum
Death during 1st 28 days of life
次要结局
- Initiation of Early Breastfeeding(1 hour postpartum)
- Exclusive Breastfeeding(6-weeks postpartum)
- Thermal Care(24 hours postpartum)
- Cord Care(2-weeks postpartum)
- Social Support(Enrollment through 6-weeks postpartum)
- Self-efficacy(Enrollment through 6-weeks postpartum)
- Early Neonatal Mortality(7 days postpartum)
- Home Provision of Kangaroo Mother Care(14 days at home postpartum)
- Maternal Knowledge of Neonatal Danger Signs(Up to 6-weeks postpartum)
- Appropriate Care-seeking(18 weeks postpartum)
- Elevated Depressive Symptoms(Enrollment through 6-weeks postpartum)
研究者
Jennifer Unger
Associate Professor, Department of Obstetrics and Gynecology
University of Washington