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

Primary Purpose

Parent Mental Health

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

PHM™ Pathway

About this trial

This is an interventional supportive care trial for Parent Mental Health focused on measuring parent, fetal anomaly, prenatal diagnosis, infant, heart disease, ehealth, intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention (PHM)

Usual Care Group (UC)

Arm Description

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.

The control group participants will receive care as usual.

Outcomes

Primary Outcome Measures

Change in State-Trait Anxiety Inventory score

State subscale, 20 items, 4-point scale; State Anxiety cut point score ≥40

Change in Center for Epidemiology Scale-Depression (CES-D) score

20 items, 4-point scale; cut point score ≥16

Change in Impact of Event Scale score

22 items, 4-point scale; cut point score ≥ 24

Secondary Outcome Measures

Full Information

NCT ID

NCT05282368

First Posted

February 7, 2022

Last Updated

April 28, 2023

Sponsor

University of Minnesota

1. Study Identification

Unique Protocol Identification Number

NCT05282368

Brief Title

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

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

November 1, 2020 (Actual)

Primary Completion Date

March 1, 2023 (Actual)

Study Completion Date

March 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parent Mental Health

Keywords

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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)

Allocation

Randomized

Enrollment

57 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention (PHM)

Arm Type

Experimental

Arm Description

Arm Title

Usual Care Group (UC)

Arm Type

No Intervention

Arm Description

The control group participants will receive care as usual.

Intervention Type

Behavioral

Intervention Name(s)

PHM™ Pathway

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in State-Trait Anxiety Inventory score

Description

State subscale, 20 items, 4-point scale; State Anxiety cut point score ≥40

Time Frame

12 weeks after birth

Title

Change in Center for Epidemiology Scale-Depression (CES-D) score

Description

20 items, 4-point scale; cut point score ≥16

Time Frame

12 weeks after birth

Title

Change in Impact of Event Scale score

Description

22 items, 4-point scale; cut point score ≥ 24

Time Frame

12 weeks after birth

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anne C McKechnie, PhD, RN

Organizational Affiliation

University of Minnesota

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Minnesota

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55455

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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