Prevent Maternal Mortality Using Mobile Technology (PM3)
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 4
- 主要终点
- Number of completion of postpartum healthcare visit ( Healthcare Resource utilization)
研究概览
简要总结
Black women who reside in a rural area are at highest risk for maternal morbidity and mortality due to a combination of social and structural causes. The postpartum period is the most critical yet most neglected phase for preventing suboptimal or fatal maternal health outcomes. The goal of this project is to use a mobile app to provide personalized support and improve the lives of women during the early postpartum period. The information the study team gathers will help educate women and all who support them about the need to seek postpartum care and the impact postpartum care can have on pregnancy-related complications. Participation in this research requires taking part in a focus group discussion which will allow participants to share or the person that supports the participant's story and experience with postpartum complications and willingness to use and desired features of a postpartum mobile app.
详细描述
Black women in Georgia have the highest risk for adverse maternal outcomes, with a staggering 66.6 deaths per 100,000 live births, compared to 18.1 for Hispanic women and 43.2 for white women. In rural Georgia, these statistics are more profound, with Black women experiencing 126.7 deaths per 100,000 live births compared to 78.3 deaths for White women. These disparities have existed for centuries and have also widened significantly over the last several decades.
The proposed research aims to increase the effectiveness of postpartum discharge education and improve rural Black women's compliance with postpartum care recommendations by developing and testing a culturally-informed "mhealth intervention" entitled Prevent Maternal Mortality using Mobile technology (PM3).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
Only the participants will be blinded to their assigned group. Immediately after participants have completed their baseline assessment, study staff will open a sealed envelope to identify the participants' group assignment.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants self -identify as female
- •Participants must self-identify as African American/Black
- •Aged 18-45 years
- •Can speak or read English
- •Participants must be able to give consent.
- •Own a smart phone
- •Reside in or near Albany, LaGrange, or Waynesboro (within a 40 mile radius)
- •Be in third trimester or recently had a baby (≤4 weeks postpartum)
- •Can be contacted by phone or email after hospital discharge.
排除标准
- •Women will be excluded if they have known unavailability to follow-up
- •An active severe mental health condition, or developmental disability precluding informed consent
结局指标
主要结局
Number of completion of postpartum healthcare visit ( Healthcare Resource utilization)
时间窗: At weeks 4 to 6 postpartum
Around 50% of the women receive a postpartum visit within that time. The study aims to increase postpartum visit attendance by 25% for a goal of 75%. The completion of a visit and other clinical outcomes will be confirmed by a medical chart review. This will be measured as number of participants completing the post partum healthcare visit.
次要结局
- Changes in Women Sexual Health History(Baseline, month 3, month 6 and month 12)
- Changes in Blood pressure(Baseline, month 3, month 6 and month 12)
- Edinburg Postpartum Depression Scale(Baseline, month 3, month 6 and month 12)
- Changes in Promis-GSF(Baseline, month 3, month 6 and month 12)
- Race-related stress (Index of Race-Related Stress-Brief)(IRRS-B)(Baseline, month 3, month 6 and month 12)
- Changes in Sleep (Karolinska Sleep Questionnaire - KSS)(Baseline, month 3, month 6 and month 12)
- General Perceived Self-Efficacy Scale(Baseline, month 3, month 6 and month 12)
- Changes in Current Life Situation(Baseline, month 3, month 6 and month 12)
- Changes in Health related quality of life questionnaires (HRQoL)(Baseline, month 3, month 6 and month 12)
- Changes in Hair cortisol levels(Baseline and 3 months)
- Discrimination & Stigma Scale(Baseline, month 3, month 6 and month 12)
- System Usability Scale(Baseline, month 3, month 6 and month 12)
- Medical Mistrust Index (MMI)(Baseline, month 3, month 6 and month 12)
- Social Support- The Medical Outcomes Study(Baseline, month 3, month 6 and month 12)
- Appraisal of self-care agency Scale-Revised (ASAS-R)(Baseline, month 3, month 6 and month 12)
- Stressful Events Questionnaire(Baseline, month 3, month 6 and month 12)
- Adverse Childhood Experiences (ACEs) questionnaire(Baseline, month 3, month 6 and month 12)
- The Neighborhood Questionnaire(Baseline, month 3, month 6 and month 12)
研究者
Natalie Hernandez
Assistant Professor
Emory University