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NCT04437069 · ClinicalTrials.gov registry record · NA
Improving Patient and Family Health Using Family-Centered Outcomes and Shared Decision-Making
A NA study of Congenital Heart Disease and Congenital Heart Defect, sponsored by University of Utah.
- Active
- Registry status
- NA
- Development phase
- 135
- Enrollment target
- 2
- Study locations
NCT04437069: Active NA study of Congenital Heart Disease and Congenital Heart Defect, sponsored by University of Utah.
NCT04437069 is a NA study of Congenital Heart Disease and Congenital Heart Defect that is active but no longer recruiting, run by University of Utah. The registered enrollment target is 135 participants, below the 472-participant average among 63 other Congenital Heart Disease trials with a reported enrollment target (71% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04437069, a NA study of Congenital Heart Disease and Congenital Heart Defect, is active but no longer recruiting, sponsored by University of Utah.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 135 participants
- Enrollment target
- 2
- Study locations
Study Summary
This study is a randomized clinical trial where participants (parents of a fetus or neonate diagnosed with a life-threatening congenital heart disease (CHD)) will randomly be assigned to either receiving a web-based decision aid (DA) alone, or receiving the decision aid that includes a values clarification exercise. Because of the novel use of decision aids in CHD in an acute setting, we will also compare participants receiving the DA in a randomized control trial to a prospective observational population of families faced with similar decisions without a DA (control group). We have designated the Brief Symptom Inventory Global Severity Index of Global Distress 3 months post-birth or death/termination as our primary outcome measure.
Primary Outcome
The BSI is a validated scale of 53 questions that indicate the degree of stress the participant has experienced within the previous seven days. Answers range in a 5 point Likert scale from 0=not at all to 4=extremely. The scale measures stress, so a lower score is better. Scores are obtained for nine primary symptom dimensions and three global indices of distress. The primary comparison is the baseline measurement versus 3 months post-decision measurement. We are looking at how those measuremen
Conditions Studied
Interventions
- OTHER Decision Aid
- OTHER Values Clarification Exercise
Study Locations (2)
Utah
- Primary Children's Hospital Fetal and Pediatric Cardiology Clinics or Cardiac or Neonatal Intensive Care Units - Salt Lake City
- University of Utah - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 135 participants |
| Start Date | 2020-10-01 |
| Est. Completion | 2026-07-30 |
| Phase | NA |
What the registry record for NCT04437069 still lists
NCT04437069 is an interventional study that assigns participants to a tested intervention. The registered 135 participants enrollment target is mid-sized for trials with a published cap, below the 472-participant average among 63 other Congenital Heart Disease trials with a reported enrollment target (71% lower).
The record links to 3 conditions, with Congenital Heart Disease appearing as the primary indexed condition, and to 2 interventions - of which Decision Aid is the first listed.
NCT04437069 reports a single indexed study location in Utah.
Frequently Asked Questions
What is clinical trial NCT04437069 about?
NCT04437069 is a clinical study titled "Improving Patient and Family Health Using Family-Centered Outcomes and Shared Decision-Making". This study is a randomized clinical trial where participants (parents of a fetus or neonate diagnosed with a life-threatening congenital heart disease (CHD)) will randomly be assigned to either receiving a web-based decision aid (DA) alone, or receiving the decision aid that includes a values clarif...
What is the current status of trial NCT04437069?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 135 participants. The study started on 2020-10-01. Estimated completion is 2026-07-30.
What conditions does trial NCT04437069 study?
This clinical trial studies the following conditions: Congenital Heart Disease, Congenital Heart Defect, Patient Decision Aids.
What interventions are being tested in trial NCT04437069?
The interventions under investigation include: Decision Aid (OTHER), Values Clarification Exercise (OTHER).
Who is sponsoring clinical trial NCT04437069?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04437069 being conducted?
This trial has 2 study locations across Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Congenital Heart Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04437069's enrollment target sits among peer trials
135 28th of 63 higher than 36 of 63 other Congenital Heart Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Congenital Heart Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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