Mobile-based Obstetric Monitoring for Pregnancies Complicated by Hypertension and/or Diabetes (MOM-HD): a Type II Hybrid Implementation-Effectiveness Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 864
- 试验地点
- 3
- 主要终点
- Mean systolic BP from recruitment to delivery (continuous)
研究概览
简要总结
Hypertensive disorders during pregnancy (HDP) and gestational diabetes (GDM) are among the leading complications in pregnancy, significantly contributing to global maternal and fetal morbidity and mortality. (1,2,3) Effective management of HDP and GDM hinges on regular monitoring of blood pressure (BP) and blood glucose (BG) to ensure adequate control and timely interventions for maternal and fetal well-being. Telemonitoring offers a promising and cost-effective alternative by enabling pregnant individuals to monitor BP and BG at home and share real-time results with healthcare providers, facilitating informed clinical decision-making and timely interventions.
Here the investigators propose to conduct a Hybrid Type II Effectiveness-Implementation Randomized Controlled Trial (RCT) to assess the effectiveness and evaluate the implementation of the MOM-HD (Mobile-based Obstetric Monitoring for Hypertension and/or Diabetes) program, a mobile app-based perinatal telemonitoring program, in real-world clinical settings in Nepal. To address the study aims, the investigators will recruit 864 women who are newly diagnosed with HDP and GDM from three metropolitan hospitals and randomly assign them to either (i) MOM-HD + standard care or (ii) standard care alone, from enrolment in pregnancy to 6 weeks postpartum. Primary and secondary clinical outcomes will be assessed at delivery, and at 6 weeks postpartum. The investigators hypothesize that compared to standard care, the use of MOM-HD in addition to standard care will result in lower systolic BP levels, lower incidence rate for the composite adverse perinatal outcome of either perinatal loss, neonatal intensive care unit admission, primary cesarean delivery or labor induction, and lower proportion of days with elevated systolic BP or BG readings between recruitment and 6 weeks postpartum. A convergent mixed-methods approach will be used to assess implementation and maintenance outcomes using the RE-AIM framework (4), and economic sustainability will be assessed by collecting primary cost data.
详细描述
This is a Mobile-based Obstetric Monitoring for Hypertension and/or Diabetes (MOM-HD)2 program, which includes a patient-facing mobile app for uploading BP/BG data, a provider-facing web portal for viewing patient data, and biweekly tele-visits with a study nurse.
This study aims to utilize an implementation science framework to implement and comprehensively evaluate a mobile app-based perinatal telemonitoring program within real-world clinical settings. Collaborating with government and hospital stakeholders, the investigators will employ a theory-informed multi-faceted implementation strategies: (a) Train patients and family members, and provide continuous technical support (via mobile app) for at-home BP and/or BG monitoring; (b) Provide financial assistance for at-home BP and/or BG monitoring; (c) Technical assistance, audit, and feedback to the providers; and (d) Institutionalizing and sustaining the program through advisory boards at each hospital.
Study Objective and Aims
Primary Goal:
To conduct a hybrid type II effectiveness-implementation randomized controlled trial (RCT) to evaluate the impact of MOM-HD on clinical outcomes and assess its implementation in real-world settings in Nepal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
The allocation sequence will be concealed from the research nurse and participants using sequentially numbered opaque sealed envelopes.
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 women receiving antenatal care at RCT site
- •Diagnosed with one of the following:
- •Chronic hypertension (sustained systolic BP ≥140 mm Hg and/or diastolic BP ≥90 mm Hg, or on antihypertensive treatment before 20 weeks of gestation)
- •Gestational hypertension or preeclampsia without severe features (sustained systolic BP ≥140 mm Hg and/or diastolic BP ≥90 mm Hg after 20 weeks of gestation)
- •Gestational diabetes
- •Age 18 years or older
- •Access to a smartphone
- •Gestational age ≤ 34 weeks at enrollment
- •Able to read and write
排除标准
- •Multifetal pregnancies
- •Apparent communication difficulties (e.g., hearing, speech, or cognitive impairments), as judged by research assistants
- •Unable to understand the Nepali language
- •Severe maternal illness or any condition that precludes active study participation (e.g., preeclampsia with severe features, eclampsia, HELLP syndrome, or other conditions requiring inpatient management)
- •Declines to provide informed consent
研究组 & 干预措施
MOM-HD Intervention Group
In addition to standard care, participants in the intervention group will use the MOM-HD telemonitoring program, which includes patient education, a blood pressure (BP) monitor and/or glucometer, and a mobile app for uploading daily BP/blood glucose (BG) readings. Women with GDM will receive both devices; those with HDP will receive a BP monitor. The MOM-HD app transfers readings via Bluetooth, provides reminders for BP/BG testing, and allows providers to review data through a secure portal. Nurses will conduct biweekly tele-visits to review results, address concerns, and connect patients with OB/GYNs or dieticians as needed. The goal is to improve self-monitoring, patient-provider communication, and timely clinical decision-making, ultimately enhancing maternal and neonatal outcomes. Both groups continue standard antenatal care, with MOM-HD designed to evaluate the added benefit of telemonitoring.
干预措施: MOM-HD (Behavioral)
Standard Care Group
In standard care, pregnant women with HDP and GDM are required to attend hospitals more frequently than the usual antenatal schedule, typically adding 6-8 extra visits for closer monitoring. The maternal-fetal medicine specialist customizes the follow-up schedule, often requiring visits every two weeks until 35 weeks, then weekly. During these visits, patients undergo tests such as ultrasounds, urine dipsticks for proteinuria, and BP/BG monitoring, with results recorded in paper booklets assigned to each patient. Additionally, women are encouraged to regularly monitor their BP and/or BG (fasting and 2-hour post-prandial) at home or at the nearest health post. GDM patients also consult a dietitian and physical therapist to develop a personalized diet and exercise plan based on pre-pregnancy weight and disease severity. OB/GYN physicians monitor BP/BG levels and adjust medications accordingly. Follow-up BP/BG testing is conducted six weeks postpartum.
干预措施: Standard Care (Other)
结局指标
主要结局
Mean systolic BP from recruitment to delivery (continuous)
时间窗: Post-treatment (at delivery)
Difference in mean systolic blood pressure between usual care and intervention group
Rate of composite adverse perinatal outcome (categorical; either perinatal loss, neonatal intensive care unit admission, primary cesarean delivery, preterm birth )
时间窗: Post-treatment (at delivery)
Perinatal loss, neonatal intensive care unit admission, primary cesarean delivery, preterm birth will be abstracted from medical records.
Proportion of days with elevated blood pressure (BP) or blood glucose (BG) readings (above clinical target ranges) between recruitment and delivery (continuous)
时间窗: Post-treatment (at delivery)
Proportion of days with elevated BP or BG readings (out of total number of days with valid measurements) will be compared between the usual care and intervention group
次要结局
- Mean diastolic BP from recruitment to delivery (continuous)(Post-treatment (at delivery))
- Mean fasting BG levels from recruitment to delivery (continuous; only among women with GDM)(Post-treatment (at delivery))
- Mean postprandial BG levels from recruitment to delivery (continuous; only among women with GDM)(Post-treatment (at delivery))
- Mean diastolic BP at 6 week postpartum (continuous)(Post-treatment (6 weeks postpartum))
- Labor induction (present/ absent)(Post-treatment (at delivery))
- Mean systolic BP at 6 week postpartum(Post-treatment (6 weeks postpartum))
- Fasting glucose at 6 weeks postpartum ( only GDM)(Post-treatment (6 weeks postpartum))
- Postprandial glucose at 6 weeks postpartum ( only GDM)(Post-treatment (6 weeks postpartum))
- Perinatal loss (present/ absent)(Post-treatment (at delivery))
- Neonatal intensive care unit admission (present/absent)(Post-treatment (at delivery))
- Primary cesarean delivery (present/absent)(Post-treatment (at delivery))
- Need for medication ( present/ absent)(Post-treatment (at delivery))
- Pre-term birth ( present/ absent)(Post-treatment (at delivery))
- Hospital admissions ( present/ absent)(Post-treatment (at delivery))
研究者
Shristi Rawal, PhD
Associate Professor
Rutgers, The State University of New Jersey