Can Targeted Education Impact the Current Standard of Care in Patients With Mild Traumatic Brain Injury?

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-08

Study Completion Date

2019-12-17

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The study will ask the question as to whether or not it is possible to deliver education material to patients with a mild traumatic brain injury in a consistent matter. The question will be asked as to whether an educational intervention decreases symptom reporting specifically looking at headache symptoms. Half of the patients will receive the current standard of care in the tertiary clinic they have been referred to while the other half will also receive the current standard of care with the addition of targeted headache educational material at various time points.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Online Memory Intervention for Individuals with Traumatic Brain Injury

NCT04331392

Brain Injuries, Traumatic Brain Injury Traumatic Severe Brain Injury Traumatic Moderate +1 more

RECRUITING NA

Improving In-hospital and Post-discharge Patient Education for Mild Traumatic Brain Injury

NCT06595914

Concussion, Mild Traumatic Brain Injury

ENROLLING_BY_INVITATION NA

Influence of Cognitive Rest on Minor Traumatic Brain Injury

NCT02116673

Minor Head Injury

COMPLETED NA

Written Versus Verbal Education for Mild Traumatic Brain Injury

NCT02252315

Mild Traumatic Brain Injury

TERMINATED NA

Spotting and Managing Adult Repeated Traumas in the Brain

NCT07025317

Brain Injury Traumatic Mild

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Post-traumatic headache is a common symptom endorsed in individuals who have suffered from mild traumatic brain injury. Headaches are often debilitating and can significantly impact a patient's ability to function and interact in society(Azulay et.al 2013).

The provision of education to patients and primary care physicians is important. There is often not enough time during clinic appointments to ensure that patients understand the pathophysiology, treatment and red-flags of their post concussive symptoms. The question is asked as to whether educational material can be delivered in a consistent and comprehensible manner.

The study will look at whether or not targeted headache education material presented to patients at multiple time points outside of the current standard of care is feasible and if there is any impact on symptom severity scores utilizing standardized surveys such as the Rivermead Post Concussion Questionnaire. A patient's frequency and type of social interactions during their recovery along with their perceived quality of life will be measured using the Participation Assessment with Recombined Tools-Objective (PART-O tool) and the Quality of Life after Brain Injury (Quolibri) tools respectively will be analyzed. By providing the basics of when to seek medical attention, the hope is be able to track what type and how frequently patients access medical treatment outside of the tertiary care clinic setting.

The investigators would like to see whether this education model is feasible and can be used as a consistent message sent to patients as well as other health care professionals.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Headache Disorders Post-Concussion Syndrome Mild Traumatic Brain Injury

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Control Feasibility trial looking at educational intervention at multiple time points during a patient's recovery from mild traumatic brain injury. The control group will be followed at these time points as well and will continue on with the current standard of care.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Subjects will be randomized via block randomization. An outcome assessor will have sealed envelopes that will assign the patients to either the intervention group versus the current standard of care. There will be three intervention time points 0, 6 and 12 weeks from the patient's initial presentation at the St. Michael's head injury clinic.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Standard of Care plus Education

Educational material will be provided at three time points along with the current standard of care provided in tertiary health care setting

Group Type EXPERIMENTAL

Education

Intervention Type OTHER

Participants in the education arm of the study will be provided with three PowerPoint presentations. Material for these slides has been adapted from material developed by the Ontario Neurotrauma Foundation. Topics to be addressed will surround post-traumatic headache and will include information regarding common symptoms, timeline for improvement, red- flags and when to seek medical attention

Standard of Care

Current standard of care provided in tertiary health care setting

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Education

Participants in the education arm of the study will be provided with three PowerPoint presentations. Material for these slides has been adapted from material developed by the Ontario Neurotrauma Foundation. Topics to be addressed will surround post-traumatic headache and will include information regarding common symptoms, timeline for improvement, red- flags and when to seek medical attention

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients must be diagnosed with a chronic ( between 2 and 4 months post injury) mTBI based on CDC criteria. They must have the ability to give consent, speak English with awareness that they will need to be contacted at various time points, and must have access to email. There will be inclusion of patients who score 3 or more on the RPQ during their initial assessment in the St. Michael's Head Injury Clinic. They must be medically stable.

Exclusion Criteria

* Patients will be excluded from the study if they have a documented history of moderate to severe traumatic brain injury. If they have a prior history of other neurological (i.e. Epilepsy, MS, Alzheimer's Disease, primary headache disorder), psychiatric (i.e. Psychotic disorder or other history of a mental health disorder) or substance abuse disorders. Subjects will be excluded if they have no fixed address or are incarcerated, as that would hinder follow up.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Andrew Baker

Role: PRINCIPAL_INVESTIGATOR

Unity Health Toronto

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

St. Michael's Hospital

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Canada

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Cindy Hunt, PH, RN

Role: CONTACT

[email protected]

Phone: 416-864-6060 ext. 77081

Candice M Todd, MD

Role: CONTACT

[email protected]

416-603-5800 ext. 6262

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Cindy Hunt, PhD.

Role: primary

[email protected]

416-864-6060 ext. 77081

Candice M. Todd, MD

Role: backup

[email protected]

6473262662

References

Explore related publications, articles, or registry entries linked to this study.

Azulay J, Smart CM, Mott T, Cicerone KD. A pilot study examining the effect of mindfulness-based stress reduction on symptoms of chronic mild traumatic brain injury/postconcussive syndrome. J Head Trauma Rehabil. 2013 Jul-Aug;28(4):323-31. doi: 10.1097/HTR.0b013e318250ebda.

Reference Type BACKGROUND

PMID: 22688212 (View on PubMed)

Collett E, Wang T, Todd C, Dosaj A, Baker A, Hunt C. Enhanced education for adult patients with persistent post-concussion headaches: a randomized controlled trial. Concussion. 2023 Jan 4;7(3):CNC102. doi: 10.2217/cnc-2022-0008. eCollection 2022 Dec.

Reference Type DERIVED

PMID: 36687215 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Study Documents

Access uploaded study-related documents such as protocols, statistical analysis plans, or lay summaries.

Document Type: Individual Participant Data Set

The Applied Health Research Centre (AHRC), an academic research organization based at St Michael's Hospital, will use software called REDCap to create the web-based electronic CRF (eCRF). Authorized personnel receive a username and password which is unique, and database access is controlled by the DCC in collaboration with the Principal Investigator.

View Document