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NCT03442114 · ClinicalTrials.gov registry record · NA
Shared-Decision Making for Hydroxyurea
A NA study, sponsored by Children's Hospital Medical Center, Cincinnati.
- Completed
- Registry status
- NA
- Development phase
- 176
- Enrollment target
NCT03442114: Completed NA study, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT03442114 is a NA study that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 176 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03442114, a NA study, has completed, sponsored by Children's Hospital Medical Center, Cincinnati.
- COMPLETED
- Registry status
- NA
- Development phase
- 176 participants
- Enrollment target
Study Summary
The goal of the study is to understand how best to help parents of young children with sickle cell disease and their clinicians have a shared discussion about hydroxyurea (one that takes into account medical evidence and parent values and preferences). The study will compare two methods to help clinicians facilitate this-a clinician pocket guide and a clinician hydroxyurea shared decision making toolkit-in a group of parents of children ages 0-5 with sickle cell disease. The investigators hope that both methods lead to parents reaching a high-quality, well-informed decision. In addition, the team hopes to demonstrate that parents who experience a shared decision will have lower anxiety and decisional uncertainty. The researchers also expect these parents to be more likely to choose hydroxyurea and that their children will have less pain, fewer hospitalizations, better developmental outcomes, and higher quality of life. The project team hopes to show that the toolkit method is easy for clinicians to use and gives parents the support needed to make an informed decision.
Primary Outcome
Decisional Conflict Scale (DCS) is a 16-item parent-completed survey that measures uncertainty experienced when feeling uninformed about options, unclear about personal values, or unsupported in making a choice. Parents report their level of agreement with each item using a 5 point likert scale (0=strongly agree to 4=strongly disagree). For the total score, items are summed, divided by 16, and multiplied by 25. All subscores consist of 3 items except the Effective Decisions subcore (4 items) tha
Interventions
- BEHAVIORAL Hydroxyurea SDM Toolkit
- BEHAVIORAL Clinician Pocket Guide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 176 participants |
| Start Date | 2018-07-12 |
| Est. Completion | 2022-02-28 |
| Phase | NA |
What the finished NCT03442114 record still lists
NCT03442114 is an interventional study that assigns participants to a tested intervention. The registered 176 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 2 interventions - of which Hydroxyurea SDM Toolkit is the first listed.
NCT03442114 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03442114 about?
NCT03442114 is a clinical study titled "Shared-Decision Making for Hydroxyurea". The goal of the study is to understand how best to help parents of young children with sickle cell disease and their clinicians have a shared discussion about hydroxyurea (one that takes into account medical evidence and parent values and preferences). The study will compare two methods to help clin...
What is the current status of trial NCT03442114?
This trial is currently completed. It is a NA study. The enrollment target is 176 participants. The study started on 2018-07-12. Estimated completion is 2022-02-28.
What interventions are being tested in trial NCT03442114?
The interventions under investigation include: Hydroxyurea SDM Toolkit (BEHAVIORAL), Clinician Pocket Guide (BEHAVIORAL).
Who is sponsoring clinical trial NCT03442114?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03442114's enrollment target sits among peer trials
176 605th of 2000 higher than 1,391 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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