- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07569354
Recovery Among Older Adults Following Mild TBI
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Development of Alzheimer's disease and related dementias (ADRD) is multifactorial, and some causal factors can be influenced or modified. Recently, the Lancet Commission included traumatic brain injury (TBI) in its list of 12 key potentially modifiable ADRD risk factors. TBI is a very common injury among older adults, resulting in over 123,000 hospitalizations and 485,000 emergency department visits annually. Importantly, rates of TBI are rapidly increasing in this population. TBI results in cognitive impairment and increases risk for both Alzheimer's disease and fronto-temporal dementia. Furthermore, TBI can result in worsened health outcomes (e.g., poor cognitive and physical functioning, psychological distress, worsened sleep quality), which in turn increase risk for ADRD. Yet, despite the large public health impact of TBI among older adults, little is known about changes in cognition and related domains following discharge from acute care in this population. Although such information is urgently needed to guide rehabilitation, care planning, and promotion of optimal long-term recovery in this vulnerable population, these data are severely lacking in the literature. One major reason for this lack of knowledge is that most prior research on TBI has focused on younger adults. Unfortunately, many findings from younger adults do not generalize to older adults due to their higher comorbidity burden and poorer cognitive and physical functioning at discharge from acute care. The objective of the proposed research is to gain an in-depth understanding of recovery of cognition, psychological and physical functioning, and sleep quality following TBI among older adults. To achieve this objective, the investigators propose to conduct a prospective cohort study of 250 patients aged 65 years and older treated for mild TBI at the R Adams Cowley Shock Trauma Center or at one of six University of Maryland Medical System affiliated hospitals with follow-up at 2 weeks and 3, 6, and 12 months to complete three Specific Aims: 1) Assess recovery of cognitive functioning and identify predictors of poor recovery; 2) Assess recovery of physical and psychological functioning and sleep quality and identify predictors of poor recovery; 3) Identify interactions between recovery trajectories.
The significance of this research is that it will identify unique recovery patterns across important domains of functioning (including cognitive function) and factors that impact the course of recovery following mild TBI among older adults. Identification of individuals at risk for poor cognitive recovery following TBI will highlight a population at high risk of ADRD and would permit targeting those individuals with cognitive rehabilitation interventions, potentially reducing ADRD risk. The rationale for the proposed study is that early identification of patients with poorer recovery trajectories will permit development and targeting of appropriately timed interventions to mitigate ADRD risk and other adverse outcomes. The potential impact of this work is that it will generate new knowledge that will guide targeted treatment efforts and inform development of a geriatric-TBI focused rehabilitation intervention that will be the focus of a future R01 application.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Jennifer Albrecht, PhD
- Número de teléfono: 410-706-0071 410-706-0071
- Correo electrónico: jalbrecht@som.umaryland.edu
Copia de seguridad de contactos de estudio
- Nombre: Michelle Newman, BSN
- Número de teléfono: 410-706-0933
- Correo electrónico: mnewman@som.umaryland.edu
Ubicaciones de estudio
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Maryland
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Baltimore, Maryland, Estados Unidos, 21201
- Reclutamiento
- University of Maryland, Baltimore
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Contacto:
- Jennifer Albrecht, PhD
- Número de teléfono: 410-706-0071 410-706-0071
- Correo electrónico: jalbrecht@som.umaryland.edu
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Contacto:
- Michelle Newman, BSN
- Número de teléfono: 410-706-0071 410-706-0933
- Correo electrónico: mnewman@som.umaryland.edu
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Investigador principal:
- Jennifer Albrecht, PhD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria
- Aged 65 years or older
- Treated for mild TBI (defined below) at the R Adams Cowley Shock Trauma Center (STC) or at one of six University of Maryland Affiliated Hospitals within 72 hours of injury
Mild TBI was defined as:
- Traumatically induced physiological disruption of brain function, as manifested by at least one of the following 1) loss of consciousness ≤30 minutes, post-traumatic amnesia <24 hours, observed or self-reported transient confusion, disorientation, or impaired consciousness, or neurologic deficit as defined by a Glasgow Coma Scale (GCS) score of 13-14 on admission.
- GCS of 15 with no other evidence of mild TBI was also accepted with positive computed tomography image.
Exclusion criteria
- Injury to any other body region resulting in an abbreviated injury scale (AIS) score >2
- Anticipation that patient would not be ambulatory at 2-weeks post-injury
- History of dementia as determined by patient/proxy report or medical history
- Non-ambulatory pre-injury
- No available proxy
- Not English speaking
- Prisoners
- Live >55 miles from the STC.
Plan de estudios
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Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Physical function
Periodo de tiempo: 2 weeks, 3, 6, and 12 months
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Short Physical Performance Battery total score.
Range 0-12, Higher scores indicating better lower extremity function
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2 weeks, 3, 6, and 12 months
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Cognition
Periodo de tiempo: 2 weeks, 3, 6, and 12 months
|
Repeatable Battery for the Assessment of Neuropsychological Status total scaled score.
The scaled score is age adjusted with a mean of 100 and a standard deviation of 15.
Scores below 100 indicate poorer cognitive function relative to same-age peers.
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2 weeks, 3, 6, and 12 months
|
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Sleep quality
Periodo de tiempo: 2 weeks, 3, 6, and 12 months
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Sleep duration in hours obtained from averaging values from participant's 1-week sleep diary.
Healthy sleep duration for older adults ranges between 7-8 hours per night.
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2 weeks, 3, 6, and 12 months
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Psychological function
Periodo de tiempo: 2 weeks, 3, 6, and 12 months
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Geriatric depression scale, 15-item version.
Range 0-15 with higher scores indicating more severe symptoms of depression.
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2 weeks, 3, 6, and 12 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Physical Function
Periodo de tiempo: 2 weeks, 3, 6, and 12 months
|
The Four-Step Square Test, measured as the number of seconds needed to complete the test.
Values greater than 15 seconds are associated with increased fall risk.
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2 weeks, 3, 6, and 12 months
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Physical Function
Periodo de tiempo: 2 weeks, 3, 6, and 12 months
|
Activities of Daily Living, range 0-6 with higher scores indicating increased independence in activities of daily living
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2 weeks, 3, 6, and 12 months
|
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Physical Function
Periodo de tiempo: 2 weeks, 3, 6, and 12 months
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Instrumental Activities of Daily Living, range 0-8 with higher scores indicating independence in instrumental activities of daily living
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2 weeks, 3, 6, and 12 months
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Physical Function
Periodo de tiempo: 2 weeks, 3, 6, and 12 months
|
Glasgow Outcomes Scale Extended, range 1-8 with higher scores indicating better recovery following traumatic brain injury
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2 weeks, 3, 6, and 12 months
|
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Cognition
Periodo de tiempo: 2 weeks, 3, 6, and 12 months
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Repeatable Battery for the Assessment of Neuropsychological Status domain scores (delayed memory, immediate memory, visuo-spatial, language, attention).
The scaled score is age adjusted with a mean of 100 and a standard deviation of 15.
Scores below 100 indicate poorer cognitive function relative to same-age peers
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2 weeks, 3, 6, and 12 months
|
|
Sleep Quality
Periodo de tiempo: 2 weeks, 3, 6, and 12 months
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Insomnia Severity Index, range 0-28 with higher scores indicating increased symptoms of insomnia
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2 weeks, 3, 6, and 12 months
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Sleep Quality
Periodo de tiempo: 2 weeks, 3, 6, and 12 months
|
Pittsburgh Sleep Quality Index, range 0-21 with higher scores indicating poorer sleep quality
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2 weeks, 3, 6, and 12 months
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Psychological Function
Periodo de tiempo: 2 weeks, 3, 6, and 12 months
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Hospital Anxiety and Depression Scale (anxiety sub-scale), range 0-21 with higher scores indicating increased symptoms of anxiety
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2 weeks, 3, 6, and 12 months
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Psychological Function
Periodo de tiempo: 2 weeks, 3, 6, and 12 months
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Rivermead post-concussion symptoms questionnaire, range 0-64 with higher scores indicating more severe post-concussive symptoms.
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2 weeks, 3, 6, and 12 months
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Jennifer Albrecht, PhD, University of Maryland
Fechas de registro del estudio
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Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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Publicado por primera vez (Actual)
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Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
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Otros números de identificación del estudio
- HP-00100973
- R01AG076441 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
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