Clinical trial NCT05282368: Preparing Heart and Mind™: A Patient Engagement Pathway for Parents and Their Caregiving Partners After a Major Fetal Anomaly Diagnosis
Official title: Preparing Heart and Mind™: A Patient Engagement Pathway for Parents and Their Caregiving Partners After a Major Fetal Anomaly Diagnosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parent Mental Health
Keywords: parent
fetal anomaly
prenatal diagnosis
infant
heart disease
ehealth
intervention
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2022-03-16
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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

Primary outcomes:
measure: Change in State-Trait Anxiety Inventory score
timeFrame: 12 weeks after birth
measure: Change in Center for Epidemiology Scale-Depression (CES-D) score
timeFrame: 12 weeks after birth
measure: Change in Impact of Event Scale score
timeFrame: 12 weeks after birth
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Anne C McKechnie, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: