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Recovery Among Older Adults Following Mild TBI

28 april 2026 bijgewerkt door: University of Maryland, Baltimore
Among fall related injuries in older adults, head injuries are the most common, yet almost nothing is known about recovery from head injury, also known as traumatic brain injury or TBI, in this population. The RETRO-TBI study is a prospective cohort study of 250 adults aged 65 and older with mild TBI to evaluate recovery in cognitive, physical and psychological function and sleep quality at four timepoints (2 weeks and 3, 6, and 12 months) over the year following injury and identify factors associated with recovery trajectories. The potential impact of this work is that it will generate new knowledge that will guide targeted treatment efforts and inform future development of strategies to optimize recovery following this common fall-related injury among older adults.

Studie Overzicht

Toestand

Werving

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

250

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

    • Maryland
      • Baltimore, Maryland, Verenigde Staten, 21201
        • Werving
        • University of Maryland, Baltimore
        • Contact:
        • Contact:
        • Hoofdonderzoeker:
          • Jennifer Albrecht, PhD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

Study population consists of adults aged 65 or older who live within 55 miles of the University of Maryland Medical Center and who have been treated for a mild traumatic brain injury at a participating emergency department within 72 hours of injury.

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Physical function
Tijdsspanne: 2 weeks, 3, 6, and 12 months
Short Physical Performance Battery total score. Range 0-12, Higher scores indicating better lower extremity function
2 weeks, 3, 6, and 12 months
Cognition
Tijdsspanne: 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.
2 weeks, 3, 6, and 12 months
Sleep quality
Tijdsspanne: 2 weeks, 3, 6, and 12 months
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.
2 weeks, 3, 6, and 12 months
Psychological function
Tijdsspanne: 2 weeks, 3, 6, and 12 months
Geriatric depression scale, 15-item version. Range 0-15 with higher scores indicating more severe symptoms of depression.
2 weeks, 3, 6, and 12 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Physical Function
Tijdsspanne: 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.
2 weeks, 3, 6, and 12 months
Physical Function
Tijdsspanne: 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
2 weeks, 3, 6, and 12 months
Physical Function
Tijdsspanne: 2 weeks, 3, 6, and 12 months
Instrumental Activities of Daily Living, range 0-8 with higher scores indicating independence in instrumental activities of daily living
2 weeks, 3, 6, and 12 months
Physical Function
Tijdsspanne: 2 weeks, 3, 6, and 12 months
Glasgow Outcomes Scale Extended, range 1-8 with higher scores indicating better recovery following traumatic brain injury
2 weeks, 3, 6, and 12 months
Cognition
Tijdsspanne: 2 weeks, 3, 6, and 12 months
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
2 weeks, 3, 6, and 12 months
Sleep Quality
Tijdsspanne: 2 weeks, 3, 6, and 12 months
Insomnia Severity Index, range 0-28 with higher scores indicating increased symptoms of insomnia
2 weeks, 3, 6, and 12 months
Sleep Quality
Tijdsspanne: 2 weeks, 3, 6, and 12 months
Pittsburgh Sleep Quality Index, range 0-21 with higher scores indicating poorer sleep quality
2 weeks, 3, 6, and 12 months
Psychological Function
Tijdsspanne: 2 weeks, 3, 6, and 12 months
Hospital Anxiety and Depression Scale (anxiety sub-scale), range 0-21 with higher scores indicating increased symptoms of anxiety
2 weeks, 3, 6, and 12 months
Psychological Function
Tijdsspanne: 2 weeks, 3, 6, and 12 months
Rivermead post-concussion symptoms questionnaire, range 0-64 with higher scores indicating more severe post-concussive symptoms.
2 weeks, 3, 6, and 12 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: Jennifer Albrecht, PhD, University of Maryland

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

11 mei 2023

Primaire voltooiing (Geschat)

31 december 2027

Studie voltooiing (Geschat)

31 december 2028

Studieregistratiedata

Eerst ingediend

1 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

28 april 2026

Eerst geplaatst (Werkelijk)

6 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

6 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

28 april 2026

Laatst geverifieerd

1 april 2026

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

Deidentified data from RETRO-TBI will be shared with eligible researchers after completion of study aims upon approval of a proposal including an analytic plan. Interested researchers should contact the PI for additional information.

IPD-tijdsbestek voor delen

Start Date: 1/1/31. No end date.

IPD-toegangscriteria voor delen

Interested researchers should contact the PI after the availability date and will be asked to submit a proposal for use of the data including an analytic plan.

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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