Can Targeted Education Impact the Current Standard of Care in Patients With Mild Traumatic Brain Injury?
试验速览
- 阶段
- 不适用
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Survey response
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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
干预措施: Education (Other)
Standard of Care
Current standard of care provided in tertiary health care setting
结局指标
主要结局
Survey response
时间窗: 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.
次要结局
- Social and Societal Functioning(12 weeks)
- Rivermead post concussion questionnaire scores (RPQ)(12 weeks)
- Access to health care(12 weeks)
- Perceived quality of life(12 weeks)