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

• ClinicalTrials.gov Identifier: NCT05282368
• Recruitment Status: Completed
• First Posted: March 16, 2022
• Last Update Posted: May 1, 2023
• Sponsor: University of Minnesota
• Information provided by (Responsible Party): University of Minnesota

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Parent Mental Health	Behavioral: PHM™ Pathway	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 57 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: This small pilot study is designed as a mixed methods randomized controlled trial to estimate and test the effect of a nurse-guided PHM™ intervention on psychological distress and perceived caregiving competencies using longitudinal, repeated measures. Qualitative and quantitative data are expected to provide crucial insights regarding app usage patterns, interactions with the nurse interventionist, and impacts of the intervention on the individual/dyad.
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Preparing Heart and Mind™: A Patient Engagement Pathway for Parents and Their Caregiving Partners After a Major Fetal Anomaly Diagnosis
• Actual Study Start Date: November 1, 2020
• Actual Primary Completion Date: March 1, 2023
• Actual Study Completion Date: March 1, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Intervention (PHM); 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.	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.
No Intervention: Usual Care Group (UC); The control group participants will receive care as usual.

Outcome Measures

Primary Outcome Measures :

1. Change in State-Trait Anxiety Inventory score [ Time Frame: 12 weeks after birth ]
   State subscale, 20 items, 4-point scale; State Anxiety cut point score ≥40
2. Change in Center for Epidemiology Scale-Depression (CES-D) score [ Time Frame: 12 weeks after birth ]
   20 items, 4-point scale; cut point score ≥16
3. Change in Impact of Event Scale score [ Time Frame: 12 weeks after birth ]
   22 items, 4-point scale; cut point score ≥ 24

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Minnesota

University of Minnesota

Minneapolis, Minnesota, United States, 55455

Sponsors and Collaborators

University of Minnesota

Investigators

• Principal Investigator: Anne C McKechnie, PhD, RN; University of Minnesota

More Information

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT05282368
• Other Study ID Numbers: SON-2019-27260
• First Posted: March 16, 2022
• Last Update Posted: May 1, 2023
• Last Verified: April 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Minnesota:

parent; fetal anomaly; prenatal diagnosis; infant; heart disease; ehealth; intervention

Additional relevant MeSH terms:

Congenital Abnormalities