Development of a Mobile Health Intervention to Improve Blood Pressure Management in Pregnancy (Moms@Home)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Home Blood Pressure Monitoring Adherence
研究概览
简要总结
This pilot study will examine the effects of a digital health approach, Moms@Home, on home blood pressure monitoring in a diverse population of pregnant women with hypertension.
详细描述
The study aims to standardize and test a storytelling approach to promote HBPM and improve BP management and pregnancy-specific outcomes in pregnant women with Hypertension (HTN). The study will integrate three components to improve BP care and outcomes: 1) the Moms@Home mobile app to promote HBPM through storytelling videos and a patient dashboard of BP data, 2) a digital BP monitor for HBPM, and 3) an HBPM report that curates and shares key health data with the right provider at the right time. Designed by and for pregnant women with HTN across racial/ethnic groups, the Moms@Home intervention is novel because it leverages digital health, behavior change techniques, and culturally relevant storytelling to improve HTN self-care while facilitating patient/caregiver communication through an HBPM report. Investigators are conducting a pilot randomized controlled trial (RCT) of Moms@Home vs. enhanced standard care, with plans to enroll 100 pregnant women (50% from racial/ethnic minority groups) with gestational or chronic HTN to determine whether Moms@Home vs. enhanced standard care (BP monitor, diary) improves HBPM adherence (primary outcome) and to evaluate the feasibility, acceptability, and sustainability of the intervention.
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
Outcome assessors will be blinded to the randomization assignments. Both investigators and participants will be aware of the randomization assignments to facilitate the implementation of the interventions.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18-50
- •English or Spanish speaking
- •A diagnosis of gestational (20-26 weeks gestational age) or chronic hypertension (8-26 weeks gestational age)
- •Singleton or multiple gestation pregnancy,
- •A patient of the University of Massachusetts Memorial Health Obstetrics/Maternal and Fetal Medicine clinics in Worcester, Massachusetts
- •Willing to share home blood pressure monitoring data
- •Comfortable with the use of smartphones and mobile apps
排除标准
- •Severe hypertension (Systolic blood pressure ≥160 mmHg or Diastolic blood pressure ≥100 mmHg)
- •Current diagnosis of preeclampsia
- •Active substance use
- •Serious physical illness (e.g., unable to interact with a smart device)
- •Enrolled in another home blood pressure monitoring program
- •Excluded from study participation by their provider
- •Inability to provide informed consent
- •Prisoners/institutionalized individuals
研究组 & 干预措施
Moms@Home arm
Participants randomized to Moms@Home will receive the Moms@Home app (± Samsung smartphone) to self-report data including home blood pressure monitoring values from a digital blood pressure monitor and physical activity data from a FitBit activity tracker.
干预措施: Moms@Home (Behavioral)
Enhanced Standard Care arm
Participants randomized to Enhanced Standard Care (ESC) will receive a paper diary to self-report data including measurements from a digital blood pressure monitor.
干预措施: Enhanced Standard of Care (Behavioral)
结局指标
主要结局
Home Blood Pressure Monitoring Adherence
时间窗: 8 weeks
Home blood pressure monitoring (HBPM) adherence is defined as performing HBPM measures ≥3 out of 7 days/week
Feasibility of the Moms@Home intervention
时间窗: 8 weeks
Among the participants in the intervention group, the feasibility of the Moms@Home intervention will be assessed through a post-intervention survey using a 5-point Likert scale, with questions on the value and overall satisfaction with the mobile intervention app. On a numeric scale, number of screened and eligible participants and the number/reason(s) for declining participation or withdrawal will be tracked.
Acceptability
时间窗: 8 weeks
Acceptability will be assessed using the System Usability Scale (SUS) and the perceived impact section of the End-user Mobile Application Rating Scale (uMARS). These are both validated measures of the usability/quality of mobile health apps. SUS is scored on a 0-100 scale, a higher score meaning better usability. The uMARS is scored on a 5-point Likert scale, with the total score calculated by averaging the scores across the items within the perceived impact subscale.
次要结局
- Physical Activity(Baseline, 4 weeks, 8 weeks)
- Self-Efficacy(Baseline, 4 weeks, 8 weeks)
- Sustainability(8 weeks)
- Blood Pressure (BP) measures(Baseline, 4 weeks, 8 weeks)
- Engagement with Moms@Home(4 weeks, 8 weeks)
- Medication Adherence(Baseline, 4 weeks, 8 weeks)
- Medication titration(Baseline, 4 weeks, 8 weeks)
- Goal attainment(Baseline, 8 weeks)
研究者
Lara Kovell
Associate Professor
University of Massachusetts, Worcester