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NCT04635475 · ClinicalTrials.gov registry record · NA
Return to Learn Implementation Bundle for Schools (RISE) After Youth Concussion
A NA study, sponsored by University of Washington.
- Completed
- Registry status
- NA
- Development phase
- 62
- Enrollment target
NCT04635475: Completed NA study, sponsored by University of Washington.
NCT04635475 is a NA study that has completed, run by University of Washington. The registered enrollment target is 62 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04635475, a NA study, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- NA
- Development phase
- 62 participants
- Enrollment target
Study Summary
Using the Consolidated Framework for Implementation Research, as our overarching conceptual framework, this translational 2 ½ year pragmatic RCT uses a clustered, stepped wedge design to test the effectiveness of a school-based (unit of analysis) implementation strategy (project intervention) called RISE (Return to Learn Implementation bundle for schools) on evidence-based practice (RTL protocol implementation; main outcome) and student outcomes (i.e., days to RTL start after diagnosis) after youth concussion. The central hypothesis is that schools in the intervention condition receiving the RISE implementation bundle (toolkit plus school support) will have more complete and sustainable RTL protocols, and better student outcomes compared to schools in control condition who receive only written RTL protocol information. As rural and low SES schools are particularly likely to struggle to implement RTL protocols,19,25 we specifically examine RISE implementation and barriers to implementation related to school demographic characteristics related to health equity. The school characteristics we examine are rurality, primary language, racial and ethnic mix, and free/reduced-cost lunch.
Primary Outcome
Tracking children's symptoms over a five-week period of time. Parental completion of 4 - week symptom checklist 100% completion of weekly symptom checklist resulting in 20% fewer symptoms for the intervention group.
Interventions
- BEHAVIORAL RISE Bundle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2021-08-30 |
| Est. Completion | 2022-06-30 |
| Phase | NA |
What the finished NCT04635475 record still lists
NCT04635475 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which RISE Bundle is the first listed.
NCT04635475 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04635475 about?
NCT04635475 is a clinical study titled "Return to Learn Implementation Bundle for Schools (RISE) After Youth Concussion". Using the Consolidated Framework for Implementation Research, as our overarching conceptual framework, this translational 2 ½ year pragmatic RCT uses a clustered, stepped wedge design to test the effectiveness of a school-based (unit of analysis) implementation strategy (project intervention) called...
What is the current status of trial NCT04635475?
This trial is currently completed. It is a NA study. The enrollment target is 62 participants. The study started on 2021-08-30. Estimated completion is 2022-06-30.
What interventions are being tested in trial NCT04635475?
The interventions under investigation include: RISE Bundle (BEHAVIORAL).
Who is sponsoring clinical trial NCT04635475?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04635475's enrollment target sits among peer trials
62 1157th of 2000 higher than 837 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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