A Culturally Adapted Digital Intervention to Promote Maternal Care Utilization Using Multifaceted Approaches (CALCIUM) Among an Ethnic Minority Community in China
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,920
- 主要终点
- Rates of Hospital Deliveries and Completion of Five Antenatal Care Visits
研究概览
简要总结
Maternal healthcare utilization is crucial for reducing maternal mortality, yet remains low in many underserved regions. The CALCIUM intervention, a culturally tailored, digital platform-integrated intervention, was developed to promote antenatal care (ANC) and institutional deliveries in Liangshan Yi Autonomous Prefecture, an ethnic minority community in China. The CALCIUM intervention was developed to address barriers including limited healthcare awareness, traditional norms and low-quality services. This intervention will evaluate the effectiveness, and cost-effectiveness of improving maternal healthcare utilization and pregnancy outcomes in an ethnic minority community.
详细描述
A cluster quasi-randomised control trial will be conducted in two counties, Xide and Yuexi, in Liangshan Yi Autonomous Prefecture, Sichuan province, China. In total, 12 towns will be randomly selected from each of the two counties (i.e., Yuexi and Xide). Within each county, the selected towns will be randomly and evenly assigned to the intervention and control groups. In each town, 80 newly pregnant women will be invited to participate. The comprehensive intervention was designed based on the Behaviour Change Wheel (BCW) including digital health education via social media platform, capacity building for healthcare providers and economic incentives for village doctors. Primary outcomes include the rates of hospital delivery and ANC utilization. Secondary outcomes include participants' pregnancy-related diseases and pregnancy outcomes. Primary and secondary outcomes will be collected through the local maternal and newborn health monitoring system. Sociodemographic and process information will be gathered through postpartum interviews. A logistic mixed model with an intention-to-treat approach will be used to evaluate the effectiveness of the intervention. Additionally, intervention costs and cost-effectiveness will be assessed.
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
- Single (Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women
排除标准
- •Not pregnant women
研究组 & 干预措施
Intervention group
Interventions including digital health education via social media platform, capacity building for healthcare providers and economic incentives for village doctors will be applied
干预措施: Health education, capacity building and economic incentives (Behavioral)
Control group
No intervention will be applied
结局指标
主要结局
Rates of Hospital Deliveries and Completion of Five Antenatal Care Visits
时间窗: Data will be collected at the end of the pregnancy
The primary outcome includes the rate of maternal care utilization, including the rate of hospital delivery and ANC utilization. According to the National Basic Public Health Service Specifications, pregnant women are advised to have their first ANC visit by the 13th week of gestation, with subsequent visits recommended during the 16-20, 21-24, 28-36, and 37-40 week periods. Timely initiation of ANC is defined as pregnant women completing their first ANC visit by the 13th week of gestation. Timely completion of five ANC visits is defined as pregnant women completing all five recommended ANC visits within the specified timeline. ANC utilization is measured by the completion of five ANC visits, the timely completion of five ANC visits, and timely initiation of ANC. The maternal and newborn health monitoring system collects routine information related to ANC utilization, place of delivery, maternal outcomes, and birth outcomes. Data will be sourced from this system.
次要结局
- Rate of Negative Pregnancy Outcomes(Data will be collected at the end of the pregnancy)
- Rate of Pregnancy-Related Diseases(Data will be collected from pregnancy through the end of the study, with an average follow-up duration of one year)
- Number of Tests Conducted(Data will be collected from pregnancy through the end of the study, with an average follow-up duration of one year)
研究者
Jiayao Xu
Postdoctoral Researcher
Zhejiang University