Written Versus Verbal Education for Mild Traumatic Brain... | NCT02252315

Studies
Written Versus Verbal Education for Mild Traumatic Brain Injury

NCT02252315

Sponsor

University of British Columbia

Status

Terminated

Last Update Posted

Nov 15, 2018Actual

Enrollment

12Actual

Phase

Not Applicable

Conditions

Mild Traumatic Brain Injury

Interventions

Educational Brochure
Verbal education module

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2018

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Low enrollment

Expanded Access Info

Start Date

Jan 2015

Primary Completion Date

Dec 2015Actual

Completion Date

Apr 2016Actual

First Submitted Date

Aug 28, 2014

First Submission Date that Met QC Criteria

Sep 25, 2014

First Posted Date

Sep 30, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 13, 2018

Last Update Posted Date

Nov 15, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Noah Silverberg, Principal Investigator, University of British ColumbiaPrincipal Investigator

Lead Sponsor

University of British ColumbiaOTHER

Collaborators

Not provided

Description Module

Brief Summary

Mild traumatic brain injury (MTBI) is a common injury that involves loss of consciousness or alteration in mental status induced by an external mechanical force to the head. Education about symptoms and reassurance of a prompt recovery usually results in full recovery. However, a subgroup appears to have persistent symptoms and disability. This study will recruit MTBI patients from two Emergency Departments with the aim of identifying modifiable patient characteristics that can delay or prevent full recovery. A secondary aim is to determine if providing education in writing or in-person makes a difference.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Written Education	Active Comparator		Other: Educational Brochure
Verbal Education	Active Comparator		Other: Verbal education module

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Educational Brochure	Other	Participants will receive written education materials about mild traumatic brain injury.	Written Education

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Presence of Postconcussional Syndrome	The primary outcome is the presence of Postconcussion Syndrome, defined as 3+ symptoms endorsed as "mild" or greater on the Rivermead Postconcussion Symptom Questionnaire.	3 Months

Secondary Outcomes

Measure	Description	Time Frame
Glasgow Outcome Scale-Extended (GOS-E)	Structured interview to assess disability level.	3 Months
Patient Health Questionnaire-9 (PHQ-9)	Depressive symptoms questionnaire.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Confirmation of a likely concussion without hospital admission
Participants live locally with a fixed address
Participants experience at least one new symptom

Exclusion Criteria:

Participants who cannot understand/read English

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Noah Silverberg, PhD	University of British Columbia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Lions Gate Hospital		Vancouver	British Columbia		Canada
Vancouver General Hospital

Condition Browse Module

MeSH Terms

ID	Term
D001924	Brain Concussion

Ancestor Terms

ID	Term
D000070642	Brain Injuries, Traumatic
D001930	Brain Injuries
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided