Headache DisordersNCT03391583
Can Targeted Education Impact the Current Standard of Care in Patients With Mild Traumatic Brain Injury?
A study testing Education in people with Headache Disorders and Post-Concussion Syndrome, run by Unity Health Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Headache Disorders, Post-Concussion Syndrome, Mild Traumatic Brain Injury
- What is being tested?
- Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteCanada
- Study dates
- 8 Jan 2018to 17 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
St. Michael's Hospital
Toronto, Ontario, M5B 1W8,
Cindy Hunt, PhD., 416-864-6060 ext. 77081, HuntCi@smh.ca
Candice M. Todd, MD, 6473262662, candice.todd@mail.utoronto.ca
About this study
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.
Read the detailed description
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.
- Being tested
- Education
- Keywords
- Education, Pain
- Medical subject headings
- Headache Disorders, Post-Concussion Syndrome, Brain Concussion, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Education |
| Standard of Care | No intervention | Current standard of care provided in tertiary health care setting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (4)
Rivermead post concussion questionnaire scores (RPQ)
The Rivermead post concussion questionnaire (RPQ) asks 16 questions about patient's headache symptoms after head injury and are given a scale from 0-4 in order to rate symptoms from none to maximum severity (0 = Not experienced at all, 1 = No more of a problem, 2 = A mild problem, 3 = A moderate problem and 4 = a severe problem).
The first three questions( RPQ-3) focuses on the most frequently endorsed headache symptoms. This study aims to reduce a patients overall score at the end of the study by 3 with the max possible score being 12 ( maximum score of 4 times 3 questions). Only those initially scoring 9 or more out of the 12 will be asked to participate in the study.
The last thirteen questions (RPQ-13) focuses on other frequently endorsed symptoms of headache. For these questions, the target is to decrease a patient's total score by 10 out of a possible maximum score of 52 (maximum score of 4 times 13 questions). Both the RPQ-3 and 13 will be compared to the standard of care.
Measured: 12 weeks
Access to health care
What type of health care services do participants in this study access. Both the educational group and the standard of care patients will be asked to document this on administered surveys
Measured: 12 weeks
Social and Societal Functioning
Can an educational intervention regarding headache management and lifestyle strategies improve social/societal functioning. This will be assessed with the Participation Assessment with Recombined Tools (PART-O tool). A 5-point decrease in total score out of 17 questions will be deemed significant.
Measured: 12 weeks
Perceived quality of life
Does education and reassurance alter a patient's perceived quality of life after a mild-traumatic brain injury. This will be analyzed by using the QOLIBRI (Quality of Life after Brain Injury).
The investigators hope to capture whether or not patients believe they play an active role in their health and whether or not they feel empowered to alter their health status.
The point is to capture what barriers there are to a patient's recovery in regard to what negative feelings and limits they perceive.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2018
- Study start8 Jan 2018
- Primary completion17 Dec 2019 (estimated)
- Study completion17 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Headache DisordersStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew Baker, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03391583
- Sponsor's protocol ID
- Grant 17-0098-GAP
- Status last verified
- Apr 2019
- First submitted
- 7 Nov 2017
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Patient study data will be de-identified or coded. A master linking log with identifiers will be kept and stored separately from the data. Data for all primary and secondary outcomes will be available.
Publications
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.
PubMed 22688212Collett 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.
PubMed 36687215
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Targeted Education Impact the Current Standard of Care in Patients With Mild Traumatic Brain Injury?
- ClinicalTrials.gov ID
- NCT03391583
- Acronym / sponsor ID
- Grant 17-0098-GAP
- Keywords
- Education, Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- 17 Dec 2019 (estimated)
- Study completion
- 17 Dec 2019 (estimated)
- First posted
- 5 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard of Care plus Education | Experimental | Other: EducationEducational material will be provided at three time points along with the current standard of care provided in tertiary health care setting |
| Standard of Care | No intervention | –Current standard of care provided in tertiary health care setting |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EducationParticipants 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 | Other | Standard of Care plus Education |
Primary outcome
Survey response
Time frame: 12 weeks
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.
4 secondary outcomes
Rivermead post concussion questionnaire scores (RPQ)
Time frame: 12 weeks
Access to health care
Time frame: 12 weeks
Social and Societal Functioning
Time frame: 12 weeks
Perceived quality of life
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
- Background: PubMed 22688212Azulay 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.
- Derived from this study: PubMed 36687215Collett 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.
- Head Injury Clinic WebsiteLink provided by the sponsor.
- Data Capture and Management at St. MichaelsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient study data will be de-identified or coded. A master linking log with identifiers will be kept and stored separately from the data. Data for all primary and secondary outcomes will be available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Baker principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education in people with Headache Disorders and Post-Concussion Syndrome, run by Unity Health Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cindy Hunt, PH, RN (Phone: 416-864-6060 ext. 77081, huntci@smh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survey response (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03391583, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2019.