Single Arm Clinical Trial of a Novel Smartphone-based Somatic and Psychological Symptom Monitoring and Decision Support Tool for African American and Spanish Speaking Patients in the Near Postpartum Period
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 4
- 主要终点
- Patient activation
研究概览
简要总结
Pregnancy-related death is a growing public health issues, which are of particular concern to minority groups, including African-Americans and Spanish-speaking Latinas. Our proposal aims to improve a patient's ability to detect warning signs of pregnancy related death and seek medical care.
详细描述
Pregnancy-related death (PRD) rates have risen 120-200% in the United States in the past two decades, and experts estimate that 40-60% of these cases are preventable. Improvement initiatives are predominantly hospital-based and rely on perinatal people recognizing their own symptoms and seeking care without ample support or education. We hypothesize that we can improve patients' self-efficacy and decision-making about when to seek care by helping them to self-monitor symptoms and by providing decision support. We propose to develop a mHealth-based, patient-reported outcome (PRO) and decision-support system to help mothers determine when to seek care for warning signs of PRD. Our project focuses on diverse populations facing postpartum disparities, particularly African- American and Spanish-speaking Latina women. This protocol involves a single-arm pilot trial assessing the feasibility and preliminary effectiveness of MOMS/MAMA for improving knowledge and patient activation among postpartum patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Greater than 28 weeks pregnant
- •Receiving healthcare in the United States
- •Age 18 years or older
- •[Identify as Black or African American race AND able to speak and read English, AND preferred language of English] OR [Identify as Hispanic/Latino Ethnicity AND Spanish able to speak and read Spanish AND preferred language of Spanish]
- •Planned delivery at the following NewYork-Presbyterian hospitals: Children's Hospital of New York, Allen Hospital, Weill Cornell Medical Center, Lower Manhattan Hospital
排除标准
- •Severe cognitive impairment
- •Major psychiatric illness
- •Concomitant terminal illness that would preclude participation.
研究组 & 干预措施
MOMS intervention
Participants in this condition will receive the MOMS symptom monitoring and decision support intervention. This is a single arm trial.
干预措施: Maternal Outcome Monitoring and Support system (Other)
结局指标
主要结局
Patient activation
时间窗: Baseline to 6 weeks postpartum
Change in patient activation measured using the validated Patient Activation Measure (PAM)
次要结局
- Knowledge of pregnancy related death warning signs(Baseline to 6 weeks postpartum)
