Preparing Heart and Mind™: A Patient Engagement Pathway for Parents and Their Caregiving Partners After a Major Fetal Anomaly Diagnosis
NCT ID: NCT05282368
Last Updated: 2023-05-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
57 participants
INTERVENTIONAL
2020-11-01
2023-03-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Lifestyle Intervention for Women With Recent Pre-eclampsia or Gestational Diabetes Mellitus ('Mom's Healthy Heart')
NCT03993145
Assessing the Effectiveness and Efficacy of the MyHealthyPregnancy Application
NCT05502510
Nursing Intervention for Knowledge and Self-care Behaviors in the Face of Hypertensive Disorders of Pregnancy
NCT05837962
Mindfetalness to Improve Pregnancy Outcome
NCT02865759
The Heart Outcomes in Pregnancy Expectations for Mom and Baby Study
NCT06517628
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
Usual Care Group (UC)
The control group participants will receive care as usual.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Minnesota
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Anne C McKechnie, PhD, RN
Role: PRINCIPAL_INVESTIGATOR
University of Minnesota
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Minnesota
Minneapolis, Minnesota, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SON-2019-27260
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.