Can Targeted Education Impact the Current Standard of Care in Patients With Mild Traumatic Brain Injury?
연구 개요
상세 설명
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.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Ontario
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Toronto, Ontario, 캐나다, M5B 1W8,
- 모병
- St. Michael's Hospital
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연락하다:
- Cindy Hunt, PhD.
- 전화번호: 77081 416-864-6060
- 이메일: HuntCi@smh.ca
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연락하다:
- Candice M. Todd, MD
- 전화번호: 6473262662
- 이메일: candice.todd@mail.utoronto.ca
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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
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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
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간섭 없음: Standard of Care
Current standard of care provided in tertiary health care setting
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Survey response
기간: 12 weeks
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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.
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12 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Rivermead post concussion questionnaire scores (RPQ)
기간: 12 weeks
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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. |
12 weeks
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Access to health care
기간: 12 weeks
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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
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12 weeks
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Social and Societal Functioning
기간: 12 weeks
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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.
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12 weeks
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Perceived quality of life
기간: 12 weeks
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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. |
12 weeks
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공동 작업자 및 조사자
수사관
- 수석 연구원: Andrew Baker, Unity Health Toronto
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- Grant 17-0098-GAP
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- CSR
연구 데이터/문서
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개별 참가자 데이터 세트
정보 댓글:
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.
약물 및 장치 정보, 연구 문서
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미국 FDA 규제 기기 제품 연구
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