Site Randomized Trial to Evaluate Behavioral Intervention Via Web-Based Application (MI MOM- Michigan Healthy Moms Application) to Improve Pregnancy Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 8
- 主要终点
- Total pregnancy-associated morbidity through one year postpartum
研究概览
简要总结
The purpose of this research study is to see if using the MI MOM App improves pregnancy and postpartum health. There are two study groups, where one group is "treatment as usual" and the other is the "MI MOM App" group. Both groups will be asked to answer questions about their pregnancy health. Researchers will also retrieve vital records and Medicaid claims information related to pregnancy for both groups. Those in the "MI MOM App" group will receive mobile web app content and text messages with informational links and links to videos and micro-interventions. They will also identify up to three close friends or family members who will be invited to receive text messages. Those in the "MI MOM App" will also have the option to contact a community health worker as needed.
详细描述
The researchers aim to use a site-randomized design to determine whether the Michigan Healthy Mom (MI MOM) app will improve pregnancy health when used by pregnant women, their supporters (partners, mothers, friends, etc.), and healthcare providers, vs treatment as usual. Specifically, the researchers will test:
- Whether use of the MI MOM app results in improvements to self-reported app targets (e.g., reducing provider bias, increasing treatment-seeking, service connection, early warning sign awareness, and improving mental health)
- Whether use of the MI MOM app improved overall pregnancy and postpartum health
- Whether the app reduced disparities in pregnancy/postpartum health, i.e. between Black and White, rural and urban participants
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
- Single (Outcomes Assessor)
盲法说明
Primary outcomes will be vital record and Medicaid claims data collected independent of this trial, and direct self-report via online survey software.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant at 20 weeks gestation or less
- •18 years of age or older
- •Access to smartphone with text messaging and internet access
- •Speaks English
- •Enrolled in Medicaid for health insurance
排除标准
- •Younger than 18 years old
- •Not pregnant or pregnant with more than 20 weeks gestation
- •No access to a smartphone with text messaging and internet access
- •Not English speaking
- •Not enrolled in Medicaid for health insurance
研究组 & 干预措施
Treatment as Usual
Data collection for study outcomes only
MI MOM
Participants receive app content and text messages with information designed to improve pregnancy outcomes.
干预措施: MI MOM App (Behavioral)
结局指标
主要结局
Total pregnancy-associated morbidity through one year postpartum
时间窗: Start of pregnancy through 1 year postpartum
Total pregnancy-associated non-severe and severe maternal morbidity through 1 year postpartum. Non-severe maternal morbidity will be indexed using ICD codes taken from Medicaid records, with conditions taken from World Health Organization-identified Maternal Morbidity conditions (e.g., anemia, hypertension, depression). Severe maternal morbidity will use ICD codes identified for the 21 severe maternal morbidity indicators developed by the CDC.
Pregnancy-Associated Mortality through one year postpartum
时间窗: Start of Pregnancy through 1 year postpartum
Total pregnancy-associated mortality through 1 year postpartum as measured using a preexisting linked dataset of Medicaid claims, deaths, birth records, and Evidence-Based Practice Center (EPC) program data.
Composite Index, total number of maternal morbidity and mortality risk factors
时间窗: Measured at 6 weeks post-baseline, 35 weeks of pregnancy, 6 weeks postpartum, 6 months postpartum, and 1 year postpartum.
A composite index evaluating multiple maternal morbidity and mortality behavioral risk factors including the Tobacco, Alcohol, Prescription medication, and other Substance use Tool for substance use (TAPS); the Humiliation, Afraid, Rape, Kick questionnaire for intimate partner violence (HARK); the Patient Health Questionnaire (PHQ-9) and Generalized Anxiety Disorder Screener (GAD-7) for symptoms of depression and anxiety; patient understanding of early warning signs of pregnancy complications and appropriate responses; confidence in ability to communicate effectively with healthcare providers; help-seeking behaviors/service utilization, and prenatal care adherence. Total score on this composite index will be the number of risks on which the participant is positive at that assessment point. All risks will refer to the time since becoming pregnant (baseline) or since the last assessment point (follow-up observations) except for depression and anxiety, which refer to the past two weeks.
次要结局
未报告次要终点
研究者
Steven J. Ondersma
Professor- Tenure System
Michigan State University