What side effects are associated with this type of intervention?

Common treatments for Congenital Heart Disease (CHD) include surgical interventions, catheter-based procedures, and pharmacotherapy. Surgical interventions can lead to side effects such as infection, bleeding, and arrhythmias. Catheter-based procedures may result in complications like blood clots, vessel damage, and infection. Pharmacotherapy, depending on the specific medication, can cause side effects ranging from gastrointestinal issues to more severe cardiac events. Utilizing web-based decision aids helps patients and families make informed choices by providing structured information and support, potentially reducing anxiety and improving satisfaction with the treatment process.

What prior FDA approvals exist?

The FDA has approved various treatments for Congenital Heart Disease (CHD), including surgical interventions, catheter-based procedures, and medications to manage symptoms and complications. While specific drugs are not detailed in the context, treatments often involve managing heart failure, arrhythmias, and other related conditions. Web-based decision aids are tools that provide structured information and support to help patients and families make informed decisions about these treatment options. These aids are particularly valuable in complex conditions like CHD, where multiple treatment pathways may exist.

What other types of research exist?

Promising, novel alternatives to Web-based Decision Aids for Congenital Heart Disease patients in 2024 include mobile health applications, virtual reality experiences, AI-driven personalized recommendations, and telemedicine consultations.

← Back to Search

Decision Aid for Congenital Heart Disease

N/A

Recruiting

Led By Angela Fagerlin, PhD

Research Sponsored by University of Utah

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Participants must be 18 years of age or older

Patients with other types of CHD that are not listed above are not eligible

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 week post-decision aid, 1 month post-decision, & 3 months post-decision

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a web-based tool to help parents of children with serious heart conditions make better treatment decisions. The tool provides information and helps clarify what is important to the parents. Researchers will see if this tool improves parents' mental health and decision-making quality.

Who is the study for?

This trial is for parents of a fetus or neonate diagnosed with specific life-threatening congenital heart diseases (CHD), such as Truncus Arteriosus and Hypoplastic Left Heart Syndrome. Both parents are invited to participate, but one parent can join if the other cannot. Participants must be adults over 18 years old without restrictions on gender, race, or socioeconomic status.

What is being tested?

The study tests a web-based decision aid designed to help parents make informed choices about their child's CHD treatment. Some will use the decision aid alone; others will have an added values clarification exercise. Their effectiveness is compared against families making decisions without any aids.

What are the potential side effects?

Since this trial involves educational tools rather than medical treatments, there are no direct physical side effects expected from participating in the study.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am 18 years old or older.

Select...

My heart condition is not listed as an eligible type for this trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 week post-decision aid, 1 month post-decision, & 3 months post-decision

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 week post-decision aid, 1 month post-decision, & 3 months post-decision

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 week post-decision aid, 1 month post-decision, & 3 months post-decision for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in the Brief Symptom Inventory (BSI) Global Severity Index of Global Distress

Secondary study objectives

Brief Symptom Inventory (BSI) Global Severity Index of Global Distress

Decision Quality - Knowledge

Decision Quality - Values

+1 more

Other study objectives

Acceptability of the Decision Aid

Combined Outcome Measure for Risk Communication and Treatment Decision Making Effectiveness (COMRADE)

Consultation Quality

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Decision Aid & Values Clarification ExerciseExperimental Treatment2 Interventions

Participants view both the Decision Aid and the Values Clarification Exercise

Group II: Decision AidExperimental Treatment1 Intervention

Participants view the Decision Aid only

Group III: Standard Care (Control)Active Control1 Intervention

Participants will receive standard care and will not view either the Decision Aid or the Values Clarification Exercise

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Congenital Heart Disease (CHD) include surgical interventions, catheter-based procedures, and pharmacotherapy. Surgical interventions, such as open-heart surgery, aim to correct structural defects, improving blood flow and heart function. Catheter-based procedures, like balloon angioplasty or stent placement, are minimally invasive techniques used to open narrowed vessels or repair defects. Pharmacotherapy involves medications that manage symptoms or prevent complications, such as diuretics to reduce fluid buildup or beta-blockers to control heart rate. These treatments are crucial for CHD patients as they address the underlying structural issues, improve quality of life, and reduce the risk of long-term complications. Decision aids help patients and families understand these options, facilitating informed decision-making and personalized care.

Recommendations for cardiovascular magnetic resonance and computed tomography in congenital heart disease: a consensus paper from the CMR/CCT working group of the Italian Society of Pediatric Cardiology (SICP) and the Italian College of Cardiac Radiology endorsed by the Italian Society of Medical and Interventional Radiology (SIRM) Part I.Pediatric cardiovascular safety: challenges in drug and device development and clinical application.