Parent Mental Health
Conditions
Keywords
parent, fetal anomaly, prenatal diagnosis, infant, heart disease, ehealth, intervention
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.
Interventions
BEHAVIORALPHM™ 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.
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in State-Trait Anxiety Inventory score | 12 weeks after birth | State subscale, 20 items, 4-point scale; State Anxiety cut point score ≥40 |
| 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 Impact of Event Scale score | 12 weeks after birth | 22 items, 4-point scale; cut point score ≥ 24 |
Countries
United States
Outcome results
None listed