NCT05282368已完成不适用
Preparing Heart and Mind™: A Patient Engagement Pathway for Parents and Their Caregiving Partners After a Major Fetal Anomaly Diagnosis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Change in Center for Epidemiology Scale-Depression (CES-D) score
研究概览
简要总结
The purpose of this study is to test and evaluate the Preparing Heart and Mind™ (PHM™) patient engagement pathway as a nurse-guided intervention to lower psychological distress and enhance caregiving competencies among mothers/birthing persons and their caregiving partners after a major fetal anomaly diagnosis.
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A study participant can include a pregnant person past 20 weeks of pregnancy (this includes a vulnerable population)
- •Willing and able to comply with study procedures.
- •Participants must be ≥ 18 years old.
- •Participants must be able to read, write and speak English.
- •Participants must have access, and ability to use a smartphone, tablet, or computer in a private location.
- •The pregnant woman/person and her caregiving partner are planning for infant delivery and care.
- •The fetal diagnosis of the major anomaly affects the heart (i.e., CCHD). See definition of CCHD included earlier in the protocol. Other anomalies could be present and potentially impair other organs.
- •The infant's anomaly will likely require surgical and/or medical intervention within the first year of life.
- •The fetus/infant is expected to live with surgical and/or medical intervention (this includes a vulnerable population).
- •There may be genetic and/or chromosomal conditions in addition to the heart/structural anomalies
排除标准
- •Pregnancy termination
- •The fetal anomaly diagnosis is highly likely to result in fetal or infant demise shortly after birth.
- •Adults lacking the capacity to consent
- •Adults who do not have access to a smart phone, tablet, or device.
- •Caregiving partner cannot enroll if mother is not enrolled
结局指标
主要结局
Change in Center for Epidemiology Scale-Depression (CES-D) score
时间窗: 12 weeks after birth
20 items, 4-point scale; cut point score ≥16
Change in Impact of Event Scale score
时间窗: 12 weeks after birth
22 items, 4-point scale; cut point score ≥ 24
Change in State-Trait Anxiety Inventory score
时间窗: 12 weeks after birth
State subscale, 20 items, 4-point scale; State Anxiety cut point score ≥40
次要结局
未报告次要终点
研究者
研究点 (2)
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