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

Not Applicable

Completed

• Conditions: Parent Mental Health
• Interventions: Behavioral: PHM™ Pathway

• Registration Number: NCT05282368
• Lead Sponsor: University of Minnesota

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-01
• Study First Submitted: 2022-02-07
• Study First Submitted QC: 2022-03-07
• Study First Posted: 2022-03-16
• Primary Completion: 2023-03-01
• Study Completion: 2023-03-01
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-28
• Last Update Posted: 2023-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention (PHM)	PHM™ Pathway	This pathway is intended to be a tool to enhance support for a mother/birthing person and her caregiving partner, facilitate communication with healthcare providers, and promote development of caregiving to optimize maternal-fetal, infant, and family health.

Primary Outcome Measures

Name	Time	Method
Change in Impact of Event Scale score	12 weeks after birth	22 items, 4-point scale; cut point score ≥ 24
Change in Center for Epidemiology Scale-Depression (CES-D) score	12 weeks after birth	20 items, 4-point scale; cut point score ≥16
Change in State-Trait Anxiety Inventory score	12 weeks after birth	State subscale, 20 items, 4-point scale; State Anxiety cut point score ≥40

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States