Influence of Cognitive Rest on Minor Traumatic Brain Injury
Primary Purpose
Minor Head Injury
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cognitive rest
Usual care
Sponsored by
About this trial
This is an interventional treatment trial for Minor Head Injury focused on measuring Head injury, Concussion, Cognitive rest, Emergency department
Eligibility Criteria
Inclusion Criteria:
- Male and female patients presenting to the ED with the Canadian Emergency Department Information System (CEDIS) chief complaint of "head injury".
- Age greater than 17 years and less than 65 years.
- Injury occurring within the last 24 hours.
Exclusion Criteria:
- Acute intracranial injury identified on head CT
- Glasgow Coma Scale (GCS) < 15 at time of discharge
- Non-English speaking
Sites / Locations
- Mount Sinai Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Control
Cognitive rest
Arm Description
The control arm receives usual care discharge instructions.
The intervention is providing discharge instructions instructing cognitive rest and graduated return to usual activities in patients whom have experienced minor traumatic brain injury.
Outcomes
Primary Outcome Measures
Minor traumatic brain injury symptoms
Measured by the Post-concussion Symptom Score (PCSS)
Secondary Outcome Measures
Days of work or school missed
Visits to the emergency department or other health care professionals
Full Information
NCT ID
NCT02116673
First Posted
April 15, 2014
Last Updated
September 22, 2015
Sponsor
Mount Sinai Hospital, Canada
1. Study Identification
Unique Protocol Identification Number
NCT02116673
Brief Title
Influence of Cognitive Rest on Minor Traumatic Brain Injury
Official Title
The Influence of Cognitive Rest and Graduated Return to Usual Activities on Minor Traumatic Brain Injury
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mount Sinai Hospital, Canada
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Background: Head injury is a common presentation to family medicine clinics and emergency departments (EDs), and the majority will not result in intracranial injury requiring neurosurgical consultation, but will have symptoms of mild traumatic brain injury (MTBI). It is estimated between 15-50% of patients with MTBI develop post-concussive syndrome (PCS). Research in the management of MTBI and prevention of PCS has been scarce to date. Although expert consensus recommends cognitive rest and graduated return to usual activities, these and other interventions are not based on prospective clinical evidence.
Objective: The purpose of this study is to determine if providing graduated return to usual activities discharge instructions to MTBI patients in the ED decreases MTBI symptoms post-injury as compared to providing usual ED MTBI discharge instructions.
Study Design: This will be a pragmatic, single-centered, 2-arm parallel-group, superiority randomized trial.
Patient Population: Male and female patients presenting to the ED ages greater than 17 and less than 65 with the Canadian Emergency Department Information System (CEDIS) presenting complaint of "head injury".
Outcomes: The primary outcome of this study is to determine if patients whom receive graduated return to usual activity discharge instructions have more clinically significant decreases in their Post-Concussion Symptom Score (PCSS) 2 weeks after MTBI versus patients who received usual care MTBI discharge instructions. Secondary outcomes include the intervention group's compliance with the intervention, comparison of PCSS between groups 4 weeks after initial ED visit, comparison of groups' number of return visit(s) to either an ED or physician's office, and the mean number of days of school or work missed for each group.
Hypothesis: Given cognitive rest and graduated return to usual activities are concepts recommended by expert consensus, it is expected patients who follow the graduated return to usual activities and cognitive rest guidelines will have less MTBI symptoms at two weeks after ED discharge.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Minor Head Injury
Keywords
Head injury, Concussion, Cognitive rest, Emergency department
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Other
Arm Description
The control arm receives usual care discharge instructions.
Arm Title
Cognitive rest
Arm Type
Experimental
Arm Description
The intervention is providing discharge instructions instructing cognitive rest and graduated return to usual activities in patients whom have experienced minor traumatic brain injury.
Intervention Type
Other
Intervention Name(s)
Cognitive rest
Intervention Description
The intervention is providing discharge instructions instructing cognitive rest and graduated return to usual activities in patients whom have experienced minor traumatic brain injury.
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
These are usual care emergency department discharge instructions provided at emergency department discharge for minor traumatic brain injury.
Primary Outcome Measure Information:
Title
Minor traumatic brain injury symptoms
Description
Measured by the Post-concussion Symptom Score (PCSS)
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Days of work or school missed
Time Frame
4 weeks
Title
Visits to the emergency department or other health care professionals
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and female patients presenting to the ED with the Canadian Emergency Department Information System (CEDIS) chief complaint of "head injury".
Age greater than 17 years and less than 65 years.
Injury occurring within the last 24 hours.
Exclusion Criteria:
Acute intracranial injury identified on head CT
Glasgow Coma Scale (GCS) < 15 at time of discharge
Non-English speaking
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine E Varner, MD
Organizational Affiliation
Mount Sinai Hospital Division of Emergency Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Influence of Cognitive Rest on Minor Traumatic Brain Injury
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