Preparing Heart and Mind™: A Patient Engagement Pathway for Parents and Their Caregiving Partners After a Major Fetal Anomaly Diagnosis

Parent Mental Health Clinical Trial

Official title:

Preparing Heart and Mind™: A Patient Engagement Pathway for Parents and Their Caregiving Partners After a Major Fetal Anomaly Diagnosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05282368
• Other study ID #: SON-2019-27260
• Status: Completed
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: March 1, 2023

Study information

• Verified date: April 2023
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 competencies among mothers/birthing persons and their caregiving partners after a major fetal anomaly diagnosis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: March 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Related Conditions & MeSH terms

• Congenital Abnormalities
• Parent Mental Health

Intervention

Behavioral:
• PHM™ Pathway
The technological platform referred to as Preparing Heart and Mind™ (PHM™) is designed as a patient engagement pathway. This platform includes GetWellNetwork's proprietary workflow engine, Patient Pathways™ and functionality of the Health Loop platform. Specifically, PHM™ will be created on a customized GetWellNetwork patient engagement pathway, getwell | Loop, which is a secure platform with a parent-facing app and an interactive dashboard for healthcare providers. The PHM™ getwell | Loop is a care program with chapters that incorporate interactive resources for patient information and education, trackers as touch points for psycho-social/educational support, and tailors care with condition-specific content, as well as action items.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in State-Trait Anxiety Inventory score	State subscale, 20 items, 4-point scale; State Anxiety cut point score =40	12 weeks after birth
Primary	Change in Center for Epidemiology Scale-Depression (CES-D) score	20 items, 4-point scale; cut point score =16	12 weeks after birth
Primary	Change in Impact of Event Scale score	22 items, 4-point scale; cut point score = 24	12 weeks after birth