Delirium Clinical Trial
Official title:
Delirium and Neuropsychological Recovery Among Emergency General Surgery Survivors (DANE)
This study will evaluate the usefulness of the Emergency General Surgery (EGS) Delirium Recovery Model. It is hypothesized that the cognitive, physical and psychological recovery of older EGS delirium survivors will be improved through the use of the EGS Delirium Recovery Model. Participants can expect to be on the study for 18 months.
Status | Recruiting |
Enrollment | 528 |
Est. completion date | January 31, 2028 |
Est. primary completion date | January 31, 2028 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility | Inclusion Criteria: - Adult age 65 years and older - Admitted to one of the participating hospitals - Undergone an abdominal orthopedic, skin, or vascular surgery in an emergency or unplanned fashion - English-speaking - Able to provide consent or have a legally authorized representative to provide consent - Access to a telephone or an internet connected computer or smart device - Discharged to home or sub-acute rehabilitation - At least one episode of delirium in the period prior to discharge from acute care Exclusion Criteria: - A self-reported diagnosis of cancer with short life expectancy - A history of dementing illnesses and other neurodegenerative disease such as Alzheimer's disease (AD), Parkinson disease, or vascular dementia, or current prescription of anti-dementia medication, or ruled out by Functional Activities Questionnaire (FAQ) score defining dementia; a history of significant traumatic brain injury - Have any spinal cord injury with persistent neurologic deficit at the time of study enrollment - Incarcerated or homeless at the time of study enrollment - Acquired neurologic injury (stroke, traumatic brain injury, cerebral edema/swelling, anoxic brain injury, or any other acute/subacute severe neurologic deficit) as the admitting diagnosis or a new event during the course of hospitalization (confirmed by EMR) - A history of bipolar disorder or schizophrenia (confirmed by EMR) |
Country | Name | City | State |
---|---|---|---|
United States | Indiana University | Indianapolis | Indiana |
United States | East Madison Hospital | Madison | Wisconsin |
United States | Meriter Hospital | Madison | Wisconsin |
United States | University of Wisconsin | Madison | Wisconsin |
United States | SwedishAmerican Hospital | Rockford | Illinois |
Lead Sponsor | Collaborator |
---|---|
University of Wisconsin, Madison | Indiana University, National Institute on Aging (NIA), SwedishAmerican Hospital, Unity Point Health - Meriter |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in overall cognitive recovery | Change in score on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) cognitive screening assessment. The measure consists of 12 subtests that contribute to a total score and Index scores across five domains: Immediate Memory, Visuospatial-Constructional, Language, Attention, and Delayed Memory. Index scores are converted to age-based standard scores (Mean = 100, Standard Deviation = 15) | Baseline, 6 months, 12 months, and 18 months | |
Secondary | Short Physical Performance Battery (SPPB) | Change in overall physical recovery will be assessed using Short Physical Performance Battery (SPPB). SPPB is a group of measures that combines the results of the gait speed, chair stand and balance tests, and yields a performance score of 0-12; 0-4 poor, 5-7 intermediate, 8-12 good. | 6 months, 12 months, and 18 months | |
Secondary | Change in overall physical recovery | Change in overall physical recovery will be assessed using 36-Item Short Form Survey (SF-36). SF-36 scale has eight components (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health). | 6 months, 12 months, and 18 months | |
Secondary | Patient Health Questionnaire-9 (PHQ-9) | Change in overall psychological recovery will be assessed using Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a nine-item depression scale with a total score from 0 to 27, with higher scores indicating greater depression. | 6 months, 12 months, and 18 months | |
Secondary | General Anxiety Disorder-7 (GAD-7) . | Change in overall psychological recovery will be assessed using General Anxiety Disorder-7 (GAD-7) to determine the impact of the intervention on participant's mood and anxiety. The GAD-7 is a seven-item anxiety scale with a total score from 0 to 27, with higher scores indicating greater anxiety. | 6 months, 12 months, and 18 months |
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