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New app aims to ease Parents' stress over Baby's heart surgery decision

NCT ID NCT04437069

Symptom relief Sponsor: University of Utah Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a web-based decision aid app can reduce stress and improve decision-making for parents whose baby is diagnosed with a life-threatening congenital heart defect. 135 parents are randomly assigned to use the app alone or with an added values clarification exercise. The main goal is to see if parents feel less distressed three months after the decision.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Decision aid app (web-based, with or without values clarification exercise)
What this could lead to
If it works, this could help parents feel less stressed and more confident when making tough choices about their baby's heart condition.
What could go wrong
This is a small, early-stage study focused on stress and decision quality, not on changing medical outcomes. The app may not reduce distress for all parents.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

135 people

The number who actually took part.

Started

Oct 2020

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Parents whose fetus/neonate was diagnosed with a life-threatening CHD that meets eligibility criteria below without restriction based on gender, race, age, or socioeconomic status. * We will request participation from both parents but will not disqualify families if only one parent participates. * Eligibility Criteria: Parents whose fetus/neonate was diagnosed with a life-threatening CHD that are offered the choice between intervention and comfort care (and in some cases termination). This is limited to the following diagnoses: Truncus Arteriosus, Pulmonary Atresia with Intact Ventricular Septum, Complex Single Ventricle, Complex Single Ventricle with Heterotaxy, Hypoplastic Left Heart Syndrome (HLHS), and Ebstein's Anomaly of the Tricuspid Valve. Exclusion Criteria: * Patients with other types of CHD that are not listed above are not eligible. * Participants must be 18 years of age or older

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Conditions

The condition(s) this trial relates to.

congenital heart disease Ebstein anomaly hypoplastic left heart syndrome persistent truncus arteriosus pulmonary atresia-intact ventricular septum syndrome univentricular cardiopathy univentricular heart

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Congenital heart defect Congenital heart disease Patient decision AIDS

Contacts and locations

Locations

  • Primary Children's Hospital Fetal and Pediatric Cardiology Clinics or Cardiac or Neonatal Intensive Care Units

    Salt Lake City, Utah, 84108, United States

  • University of Utah

    Salt Lake City, Utah, 84108, United States

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