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

NCT03391583 | Unknown DMC

• 1 other identifier: Grant 17-0098-GAP
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Headache Disorders; Post-Concussion Syndrome; Mild Traumatic Brain Injury

Keywords

Education; Pain

Outcome Measures

Primary Outcomes (1)

• Survey response

  How many people randomized to the study will complete the study. This will be a raw number and calculated by counting how many people complete the administered surveys at the end of the trial.

  12 weeks

Secondary Outcomes (4)

• Rivermead post concussion questionnaire scores (RPQ)

  12 weeks

• Access to health care

  12 weeks

• Social and Societal Functioning

  12 weeks

• Perceived quality of life

  12 weeks

Study Arms (2)

Standard of Care plus Education

EXPERIMENTAL

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

Other: Education

Standard of Care

NO INTERVENTION

Current standard of care provided in tertiary health care setting

Interventions

Education 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 plus Education

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B 1W8,, Canada

RECRUITING

Related Publications (2)

• 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.

  PMID: 22688212 BACKGROUND

• 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.

  PMID: 36687215 DERIVED

Related Links

• Head Injury Clinic Website
• Data Capture and Management at St. Michaels

MeSH Terms

Conditions

Headache Disorders; Post-Concussion Syndrome; Brain Concussion; Pain

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Head Injuries, Closed; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Wounds, Nonpenetrating; Brain Injuries, Traumatic; Brain Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Andrew Baker

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cindy Hunt, PH, RN

CONTACT

Phone: 416-864-6060; huntci@smh.ca

Candice M Todd, MD

CONTACT

416-603-5800; candice.todd@mail.utoronto.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 7, 2017
• First Posted: January 5, 2018
• Study Start: January 8, 2018
• Primary Completion: December 17, 2019
• Study Completion: December 17, 2019
• Last Updated: April 18, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The data will be available 6 months post study completion.
• Access Criteria: Data access requests will be independently reviewed by the St. Michael's Steering Committee. Requesters will sign a Data Access Agreement.

Locations

CA (1)