Concussion, MildNCT04635475
Return to Learn Implementation Bundle for Schools (RISE) After Youth Concussion
A study testing RISE Bundle in people with Concussion, Mild, run by University of Washington at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Concussion, Mild
- What is being tested?
- RISE Bundle
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2021to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Inclusion Criteria: Public high school student, grade 9th - 12th who has sustained a concussion.
- High School Student between the age of 14-19, who attends in person, online, or a hybrid academic platform, and the concussion did not include an acute care hospital course greater than 48 hours.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
As you are aware, COVID caused us to consider how to complete this project and answer the scientific questions posed in the Specific Aims. The investigators considered shifting the RTL project to a later time and switching with another project but this would not have worked for the other project.
To solve this challenge of impact of school changes, the investigators convened with the project advisory board for consultation, consulted the research core at HIPRC and contacted the participants who were to have been participants in the randomized controlled trial. 19 of the 24 schools responded. From this work, the investigators agreed that since the school context has changed to either home online or hybrid mode, that students with concussion who are the recipients of the intervention should not be deprived of an intervention that is potentially beneficial.
The investigators have therefore made the following adaptations that retained the specific aims and central hypothesis that school context capacity can be strengthened to provide tailored student-centered RTL care and improve outcomes for students with a concussion.
To this end, the investigators are considering "school" wherever students are receiving an education. The investigators will recruit subjects who are currently largely coordinating education due to COVID, work with their schools, and recruit nationally. These adaptations will require a sample size of a total of 150 high school students with recent concussion (75 intervention [Group A: RISE bundle + CDC information], 75 controls [Group B: CDC information only]) who will be recruited using social media and other platforms.
There are some advantages to this design: 1) The investigator's intervention materials will now be able to be translated to Spanish due to adaptations, 2) This project will reach more particpants in rural and from disadvantaged backgrounds, 3) Communications between particpants and schools will be enhanced.
Given return to school, we have reverted to the stepped wedge study design in WA state.
- Conditions
- Concussion, Mild
- Being tested
- RISE Bundle
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RISE BundleBehavioural
Toolkit to build capacity where students receive education and provide symptom based and tailored accommodations after concussion
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Consented parents of a concussed high school student who will receive CDC Head's UP Concussion Guidelines during a five week program. 75 Participants. |
| Intervention Group | Experimental | Consented parents of a concussed high school student who will receive the CDC Head's Up Concussion Guidelines and intervention RTL Student Protocol during a five week program. 75 Participants. Receives: Behavioral: RISE Bundle |
What is being measured
The primary outcome is the main question the study is designed to answer.
RTL OUTCOMES - Symptom
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.
Measured: 5 week
Secondary outcomes (1)
RTL OUTCOMES - Academic Success
Outcome measures to assess academic success. Parental completion of CLASS survey weeks 2 and 4 resulting in a 20 % less decline Intervention group.
Measured: 5 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start30 Aug 2021
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Concussion, MildStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Testing RISE bundle to improve RTL care after concussion
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Monica Vavilala, University of Washington
- Investigators
- Monica S Vavilala, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04635475
- Sponsor's protocol ID
- STUDY00008181
- Other IDs
- 1R49CE003087-01
- Status last verified
- Dec 2024
- First submitted
- 5 Nov 2020
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will not share individual participant data
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Return to Learn Implementation Bundle for Schools (RISE) After Youth Concussion
- ClinicalTrials.gov ID
- NCT04635475
- Acronym / sponsor ID
- STUDY00008181
- Conditions
- Concussion, Mild
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 30 Aug 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 19 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
As you are aware, COVID caused us to consider how to complete this project and answer the scientific questions posed in the Specific Aims. The investigators considered shifting the RTL project to a later time and switching with another project but this would not have worked for the other project.
To solve this challenge of impact of school changes, the investigators convened with the project advisory board for consultation, consulted the research core at HIPRC and contacted the participants who were to have been participants in the randomized controlled trial. 19 of the 24 schools responded. From this work, the investigators agreed that since the school context has changed to either home online or hybrid mode, that students with concussion who are the recipients of the intervention should not be deprived of an intervention that is potentially beneficial.
The investigators have therefore made the following adaptations that retained the specific aims and central hypothesis that school context capacity can be strengthened to provide tailored student-centered RTL care and improve outcomes for students with a concussion.
To this end, the investigators are considering "school" wherever students are receiving an education. The investigators will recruit subjects who are currently largely coordinating education due to COVID, work with their schools, and recruit nationally. These adaptations will require a sample size of a total of 150 high school students with recent concussion (75 intervention [Group A: RISE bundle + CDC information], 75 controls [Group B: CDC information only]) who will be recruited using social media and other platforms.
There are some advantages to this design: 1) The investigator's intervention materials will now be able to be translated to Spanish due to adaptations, 2) This project will reach more particpants in rural and from disadvantaged backgrounds, 3) Communications between particpants and schools will be enhanced.
Given return to school, we have reverted to the stepped wedge study design in WA state.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Testing RISE bundle to improve RTL care after concussion
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Consented parents of a concussed high school student who will receive CDC Head's UP Concussion Guidelines during a five week program. 75 Participants. |
| Intervention Group | Experimental | Behavioral: RISE BundleConsented parents of a concussed high school student who will receive the CDC Head's Up Concussion Guidelines and intervention RTL Student Protocol during a five week program. 75 Participants. |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RISE BundleToolkit to build capacity where students receive education and provide symptom based and tailored accommodations after concussion | Behavioural | Intervention Group |
Primary outcome
RTL OUTCOMES - Symptom
Time frame: 5 week
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.
1 secondary outcome
RTL OUTCOMES - Academic Success
Time frame: 5 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Consolidated FrameworkLink provided by the sponsor.
- Individual participant dataSharing planned: No. We will not share individual participant data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monica S Vavilala, MD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RISE Bundle in people with Concussion, Mild, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RTL OUTCOMES - Symptom (time frame: 5 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024.