Evaluation of Military Service and Family Members for Post Concussive and Posttraumatic Stress Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 424
- 试验地点
- 1
- 主要终点
- Broad-spectrum military subject recruitment database
研究概览
简要总结
This protocol is designed to facilitate the recruitment, screening and registry of Military Service Members (SMs) and individuals eligible for care in the Department of Defense (DoD) healthcare system. This protocol will serve as an entry point for SMs, retirees and other beneficiaries, to facilitate their participation in Center for Neuroscience and Regenerative Medicine (CNRM)-sponsored clinical research studies at participating CNRM sites. Specifically, this protocol will be comprised of an initial evaluation of participants, to include questionnaires, a blood draw, and neuroimaging. This evaluation will enable investigators to direct participants to CNRM-sponsored natural history, observational, or interventional protocols that are most relevant to the individual interests and needs of each participant. Other approved CNRM protocols may continue to recruit participants directly into their respective studies, and may refer participants to this study.
The objective of this protocol is to develop a broad-spectrum military subject recruitment database that will collect and store preliminary data on research participants who are interested in and potentially eligible for current and future CNRM sponsored studies. The effectiveness of the recruitment methods utilized in this protocol will be evaluated to determine the most successful outreach approaches and recruitment tools for the enrollment of participants, including both active and reserve component SMs along with others who are eligible for care in the DoD healthcare system, who have experienced traumatic brain injury (TBI), psychological health (PH) concerns, or are interested in participating in studies as controls. Control participants may include (i) those with exposure to primary blast without the development of TBI, (ii) those with physical injuries without experiencing head injury, and (iii) healthy participants (non-injured, non-TBI, non-PH).
详细描述
This protocol is designed to facilitate the recruitment, screening and registry of Military Service Members (SMs) and individuals eligible for care in the Department of Defense (DoD) healthcare system. This protocol will serve as an entry point for SMs, retirees and other beneficiaries, to facilitate their participation in Center for Neuroscience and Regenerative Medicine (CNRM)-sponsored clinical research studies at participating CNRM sites. Specifically, this protocol will be comprised of an initial evaluation of participants, to include questionnaires, a blood draw, and neuroimaging. This evaluation will enable investigators to direct participants to CNRM-sponsored natural history, observational, or interventional protocols that are most relevant to the individual interests and needs of each participant. Other approved CNRM protocols may continue to recruit participants directly into their respective studies, and may refer participants to this study.
The objective of this protocol is to develop a broad-spectrum military subject recruitment database that will collect and store preliminary data on research participants who are interested in and potentially eligible for current and future CNRM sponsored studies. The effectiveness of the recruitment methods utilized in this protocol will be evaluated to determine the most successful outreach approaches and recruitment tools for the enrollment of participants, including both active and reserve component SMs along with others who are eligible for care in the DoD healthcare system, who have experienced traumatic brain injury (TBI), psychological health (PH) concerns, or are interested in participating in studies as controls. Control participants may include (i) those with exposure to primary blast without the development of TBI, (ii) those with physical injuries without experiencing head injury, and (iii) healthy participants (non-injured, non-TBI, non-PH).
This protocol will serve four purposes: (i) provide a centralized resource to identify and screen individuals in order to facilitate their participation in ongoing CNRM studies, (ii) for participants who provide informed consent to do so, to confidentially and securely collect, store, and disseminate to other CNRM investigators existing personally identifiable information (PII), existing protected health information (PHI) and data collected as part of research under this protocol, (iii) provide a mechanism for following and contacting subjects for participation in future CNRM studies, and (iv) assess the impact of TBI and PH issues upon structural and functional imaging measures to provide a more comprehensive overview of participants being referred to other CNRM studies.
Research Design:
This is an "umbrella" cohort study designed to facilitate recruitment of military SMs and others eligible for care in the DoD healthcare system in order to collect preliminary data pertaining TBI, postconcussive syndrome (PCS), posttraumatic stress (PTS), and/or other PH concerns, along with comparable data on relevant control groups. Important control comparisons are a) those with exposure to primary blast without the development of TBI, b) those with other types of physical injuries without head injury exposure, and c) healthy controls. These control comparisons are necessary to address pertinent research questions on PCS and PTS. Based on the information provided by each participant, as well as their preferences expressed during their initial contact with study staff, each may either be directly referred to appropriate CNRM protocols, informed that he/she is not eligible for any other actively enrolling CNRM studies at this time, or proceed with full participation in this enrollment protocol.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, at least 18 years of age.
- •Active duty, retired military SM, TRICARE eligible reservist or National Guardsman, or a family member eligible for care in the DoD healthcare system.
- •Ability to provide self-consent
- •For TBI participants, must report having symptoms or diagnosis of a concussion, TBI with or without loss of consciousness, or PCS; the duration of time since the head injury will be documented, but there is no limitation on duration since some CNRM studies do not place a time limit. Medical documentation is preferred but not required
- •For participants with psychological health concerns, must report having current symptoms or may already have a diagnosis of PTSD, depression, or generalized anxiety disorder.
- •For injured participants without TBI, must be (i) exposed to primary blast or (ii) have other orthopedic and/or soft-tissue injury for which they sought care at a medical treatment facility within the past six months. Injury sustained can be combat or non-combat related.
- •For healthy controls, must be healthy with no prior diagnosis of TBI, concussion, PTSD, and/or other PH issues, and no history of exposure to blast.
- •Are willing to have their contact information and data shared and stored by the CNRM for referral to current and future CNRM studies.
排除标准
- •Individuals who are unable to provide their own informed consent for the study
- •Individuals who are unwilling or unable to cooperate with study procedures
- •Individuals with penetrating brain injury with residual shrapnel or other MRI-incompatible metal embedded in the brain or skull (excluded from MRI only, can still take part in study)
- •Individuals with contraindication to MRI scanning including certain metal implants or devices (excluded from MRI only, can still take part in study)
- •Those with conditions precluding entry or prolonged durations in the MRI scanners, e.g. morbid obesity, severe claustrophobia, etc., (excluded from MRI only, can still take part in study)
- •Pregnancy: urine pregnancy tests will be performed on all females prior to the conduct of MRI; if a positive pregnancy test is identified, MRI will not be performed, can still take part in study.
- •Individuals with self reported psychosis, schizophrenia, schizoaffective disorder, bipolar disorder, conversion disorder or personality disorder.
结局指标
主要结局
Broad-spectrum military subject recruitment database
时间窗: five years
Capture data for up to 2000 male and female service members, as well as others who are also eligible for care in the DoD healthcare system, with signs and symptoms of TBI , PCS, PTS or PTSD and/or other PH concerns, or relevant controls. Assessments and procedures include self-report questionnaires, brief physical exam, neuroimaging, neurocognitive assessment, and blood sample collection. Data collected will be stored and managed by the CNRM data repositories.
次要结局
- Improvement of recruitment methods(five years)
- Enrollment and referral(five years)
- Recruitment databases(five years)