Status:
COMPLETED
Preparing Heart and Mind™: A Patient Engagement Pathway for Parents and Their Caregiving Partners After a Major Fetal Anomaly Diagnosis
Lead Sponsor:
University of Minnesota
Conditions:
Parent Mental Health
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2023
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT05282368
Start Date
November 1 2020
End Date
March 1 2023
Last Update
May 1 2023
Active Locations (1)
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1
University of Minnesota
Minneapolis, Minnesota, United States, 55455