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临床试验/NCT06415942
NCT06415942已完成不适用

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

Columbia University4 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2024年12月11日最近更新:
适应症
干预措施

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

Experimental

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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