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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 week post-decision aid, 1 month post-decision, & 3 months post-decision
Awards & highlights

Study Summary

This trial is testing a decision aid for parents of fetuses or neonates with life-threatening congenital heart disease. The goal is to help them make informed decisions about treatment options. The primary outcome measure is the parents' global distress 3 months after the child is born or dies/is terminated.

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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in the Brief Symptom Inventory (BSI) Global Severity Index of Global Distress
Secondary outcome measures
Brief Symptom Inventory (BSI) Global Severity Index of Global Distress
Decision Quality - Knowledge
Decision Quality - Values
+1 more
Other outcome measures
Acceptability of the Decision Aid
Combined Outcome Measure for Risk Communication and Treatment Decision Making Effectiveness (COMRADE)
Consultation Quality
+10 more

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

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor
1,099 Previous Clinical Trials
1,778,507 Total Patients Enrolled
American Heart AssociationOTHER
326 Previous Clinical Trials
4,933,615 Total Patients Enrolled
Angela Fagerlin, PhDPrincipal InvestigatorUniversity of Utah
2 Previous Clinical Trials
2,883 Total Patients Enrolled

Media Library

Decision Aid Clinical Trial Eligibility Overview. Trial Name: NCT04437069 — N/A
Congenital Heart Disease Research Study Groups: Standard Care (Control), Decision Aid, Decision Aid & Values Clarification Exercise
Congenital Heart Disease Clinical Trial 2023: Decision Aid Highlights & Side Effects. Trial Name: NCT04437069 — N/A
Decision Aid 2023 Treatment Timeline for Medical Study. Trial Name: NCT04437069 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Medical Decision MakingJournal
Validation of a Decisional Conflict Scale
O'Connor, Annette M.. 1995. “Validation of a Decisional Conflict Scale”. Medical Decision Making. SAGE Publications. doi:10.1177/0272989x9501500105.
BMC Medical Informatics and Decision MakingJournal
Clarifying Values: An Updated Review
Fagerlin, Angela, Michael Pignone, Purva Abhyankar, Nananda Col, Deb Feldman-Stewart, Teresa Gavaruzzi, Jennifer Kryworuchko, et al.. 2013. “Clarifying Values: An Updated Review”. BMC Medical Informatics and Decision Making. Springer Science and Business Media LLC. doi:10.1186/1472-6947-13-s2-s8.
Patient Education and CounselingJournal
Validation of a Preparation for Decision Making Scale
Bennett, Carol, Ian D. Graham, Elizabeth Kristjansson, Stephen A. Kearing, Kate F. Clay, and Annette M. O’Connor. 2010. “Validation of a Preparation for Decision Making Scale”. Patient Education and Counseling. Elsevier BV. doi:10.1016/j.pec.2009.05.012.
Medical Decision MakingJournal
Validation of a Decision Regret Scale
Brehaut, Jamie C., Annette M. O'Connor, Timothy J. Wood, Thomas F. Hack, Laura Siminoff, Elisa Gordon, and Deb Feldman-Stewart. 2003. “Validation of a Decision Regret Scale”. Medical Decision Making. SAGE Publications. doi:10.1177/0272989x03256005.
All > Heart Disease
~54 spots leftby Jun 2025
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