Written Versus Verbal Education for Mild Traumatic Brain Injury

NCT ID: NCT02252315

Last Updated: 2018-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-04-30

Brief Summary

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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

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Conditions

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Mild Traumatic Brain Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Written Education

Group Type ACTIVE_COMPARATOR

Educational Brochure

Intervention Type OTHER

Participants will receive written education materials about mild traumatic brain injury.

Verbal Education

Group Type ACTIVE_COMPARATOR

Verbal education module

Intervention Type OTHER

A structured in-person education module about mild traumatic brain injury.

Interventions

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Educational Brochure

Participants will receive written education materials about mild traumatic brain injury.

Intervention Type OTHER

Verbal education module

A structured in-person education module about mild traumatic brain injury.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Noah Silverberg

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Noah Silverberg, PhD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

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Lions Gate Hospital

Vancouver, British Columbia, Canada

Site Status

Vancouver General Hospital

Vancouver, British Columbia, Canada

Site Status

Countries

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Canada

Other Identifiers

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H13-01647

Identifier Type: -

Identifier Source: org_study_id

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