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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT05282368
Recruitment Status : Completed
First Posted : March 16, 2022
Last Update Posted : May 1, 2023
Information provided by (Responsible Party):
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.

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

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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

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.

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

Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05282368

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United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota
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Principal Investigator: Anne C McKechnie, PhD, RN University of Minnesota
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT05282368    
Other Study ID Numbers: SON-2019-27260
First Posted: March 16, 2022    Key Record Dates
Last Update Posted: May 1, 2023
Last Verified: April 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Minnesota:
fetal anomaly
prenatal diagnosis
heart disease
Additional relevant MeSH terms:
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Congenital Abnormalities