Alabama Womb to Heart Solution: A Community-Based Cardiovascular Health Intervention After Hypertension in Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 174
- 试验地点
- 1
- 主要终点
- Systolic Blood Pressure (SBP)
研究概览
简要总结
High blood pressure during or after pregnancy (such as preeclampsia, gestational hypertension, eclampsia, or Hemolysis, Elevated Liver enzymes, and Low Platelet (HELLP) syndrome) raises a mother's risk of heart disease later in life. Many patients do not return for follow-up care after delivery, missing a key window to protect their heart health. The Alabama Womb to Heart Solution (AW2H) trial will test whether pairing postpartum patients with a trained community health worker (CHW) for 6 months lowers blood pressure compared with usual care.
A total of 174 postpartum patients who had pregnancy-associated hypertension or stage 2 high blood pressure will be randomly assigned (1:1) to usual care or usual care plus the AW2H CHW program. All participants receive education on measuring their own blood pressure and a pregnancy-validated home blood pressure monitor. Participants in the CHW group are also contacted regularly by a CHW for 6 months. CHWs coach home blood pressure monitoring, support taking blood pressure medications as prescribed, encourage heart-healthy habits based on the American Heart Association's Life's Essential 8 (LE8), help schedule a primary care visit, provide mother-baby education (such as safe sleep and immunizations), and offer emotional support.
The main outcome is systolic blood pressure 6 months after enrollment, measured at home with the study-provided monitor while a research coordinator observes in person or by video/phone. The study will also look at diastolic blood pressure and whether participants scheduled a primary care visit. Interviews and focus groups will explore participant, CHW, and provider experiences with the program.
详细描述
This is a single-site, two-arm, parallel, randomized controlled efficacy trial conducted at the University of Alabama at Birmingham (UAB), building on the Alabama Womb to Heart Solution (AW2H) feasibility/acceptability pilot (NCT06353256, N=61). Postpartum patients with pregnancy-associated hypertension (gestational hypertension, preeclampsia, eclampsia, hypertension with superimposed preeclampsia, or hemolysis, elevated liver enzymes, and low platelet count [HELLP] syndrome) or stage 2 hypertension (systolic blood pressure [SBP] >=140 mmHg or diastolic blood pressure [DBP] >=90 mmHg) are randomized 1:1 to usual care or usual care plus a 6-month community health worker (CHW) intervention delivered in partnership with ConnectionHealth.
Usual care (both arms) includes brief self-measured blood pressure education, a pregnancy-validated iHealth blood pressure (BP) Cuff Kit (provided through partnership with the Preeclampsia Foundation), and written education on hypertensive disorders of pregnancy and long-term cardiovascular risk. The CHW intervention adds visits or contacts approximately 2 times per week for weeks 1-5, weekly for weeks 6-12, and monthly for weeks 13-26 (in person or virtual), covering home BP monitoring coaching with American College of Obstetricians and Gynecologists (ACOG)-concordant escalation guidance, medication adherence, postpartum and pediatric visit reminders, breastfeeding and contraception counseling, Life's Essential 8 behavior coaching, primary care linkage, mother-baby education, and trauma-informed emotional support.
The primary outcome is mean systolic blood pressure at 6 months post-enrollment (mean of 3 readings taken 1 minute apart with the validated iHealth monitor, following a protocol adapted from the Chronic Hypertension and Pregnancy (CHAP) Maternal Follow-up Study). The trial provides 80% power to detect a 7 mmHg difference in SBP (standard deviation [SD] 14.5, two-sided alpha=0.05) with 138 participants; enrollment of 174 allows for 20% attrition. Analysis follows intent-to-treat principles. Aim 2 comprises qualitative interviews (up to 20 intervention-arm participants) and two focus groups (CHWs/ConnectionHealth leadership; healthcare providers) analyzed thematically to inform future implementation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Participants and community health workers cannot be masked. The primary outcome is device-measured under a standardized protocol observed by a research coordinator.
入排标准
- 年龄范围
- 16 Years 至 56 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postpartum patients with pregnancy-associated hypertension (gestational hypertension, preeclampsia, eclampsia, hypertension with superimposed preeclampsia, or hemolysis, elevated liver enzymes, and low platelet count [HELLP] syndrome) or stage 2 hypertension per American College of Cardiology/American Heart Association (ACC/AHA) guidelines (systolic blood pressure [SBP] >=140 mmHg or diastolic blood pressure [DBP] >=90 mmHg) on two separate occasions at delivery-related hospital discharge or during the postpartum period
- •Delivered in the last six weeks at >=14 weeks gestational age, including pregnancy loss
- •16-56 years old
- •Speaks and writes in English
- •Delivering at University of Alabama at Birmingham (UAB) Hospital
排除标准
- •Declines randomization
- •Does not speak English
- •Currently incarcerated
- •Currently enrolled in other community health worker studies or services
研究组 & 干预措施
Usual Care
CVD-prevention education before hospital discharge from the delivery-associated hospitalization, including brief self-measured blood pressure education, a pregnancy-validated iHealth BP Cuff Kit, and written education on hypertensive disorders of pregnancy, long-term cardiovascular risk, and postpartum danger signs.
干预措施: Usual postpartum care with SMBP education and home BP monitor (Other)
Usual Care + AW2H Community Health Worker Program
Usual care (as in Arm 1) plus enrollment in the AW2H community health worker (CHW) program for 6 months.
干预措施: Usual postpartum care with SMBP education and home BP monitor (Other)
结局指标
主要结局
Systolic Blood Pressure (SBP)
时间窗: 6 months post-enrollment
Mean systolic blood pressure in mmHg, calculated as the mean of 3 readings taken 1 minute apart using a pregnancy-validated iHealth home blood pressure monitor, following a standardized measurement protocol during an in-person or coordinator-observed virtual visit.
次要结局
- Diastolic Blood Pressure (DBP)(6 months post-enrollment)
- Scheduling of a Primary Care Visit(By 6 months post-enrollment)
研究者
Jesse Rattan
Assistant Professor, Department of Obstetrics & Gynecology
University of Alabama at Birmingham