Elektroniske nevrokognitive verktøy i screening for mental kapasitet hos pasienter som gjennomgår leverkirurgi
En mulighetsstudie av elektroniske nevrokognitive screeningsverktøy i kirurgi
This trial studies how well electronic neurocognitive tools work in screening for mental capability in patients who are undergoing liver surgery. Using electronic neurocognitive screening tools may help to better assess mental impairment.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
PRIMARY OBJECTIVES:
I. Evaluate feasibility of the electronic batteries, measured by the completion rate and time to completion of the batteries.
SECONDARY OBJECTIVES:
I. Comparison of the completion rate and time to completion between the written and electronic batteries.
II. Comparison of the scoring distribution between the screening tools.
EXPLORATORY OBJECTIVES:
I. Assess if a history of mental or cognitive illness or ongoing treatment with neuropsychiatric medications impact the ability to complete written and/or electronic neurocognitive screening.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive the BrainCheck cognitive assessment over 15 minutes followed by the paper and pen cognitive assessment within 2 months prior to surgery and within 2 months after surgery.
GROUP II: Patients receive the paper and pen cognitive assessment followed by the BrainCheck cognitive assessment over 15 minutes 2 months prior to surgery and within 2 months after surgery.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Texas
-
Houston, Texas, Forente stater, 77030
- M D Anderson Cancer Center
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- All English-speaking patients undergoing hepatectomy at main campus University of Texas (UT)-MD Anderson Cancer Center who are cognitively able to provide informed consent in the opinion of the attending physician.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Enhetens gjennomførbarhet
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Group I (BrainCheck and paper and pen cognitive assessment)
Patients receive the BrainCheck cognitive assessment over 15 minutes followed by the paper and pen assessment 2 months prior to surgery and within 2 months after surgery. |
Receive BrainCheck cognitive assessment
Andre navn:
Receive pen and paper cognitive assessment |
|
Aktiv komparator: Group II (pen and paper and BrainCheck cognitive assessment)
Patients receive the paper and pen assessment followed by the BrainCheck cognitive assessment over 15 minutes 2 months prior to surgery and within 2 months after surgery. |
Receive BrainCheck cognitive assessment
Andre navn:
Receive pen and paper cognitive assessment |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Completion rate of the BrainCheck battery
Tidsramme: Up to 1 year
|
Will be calculated along with a 95% confidence interval (CI). |
Up to 1 year
|
|
Completion rate of the pen and paper assessment
Tidsramme: Up to 1 year
|
Will be calculated along with a 95% CI. |
Up to 1 year
|
|
Average time to complete the BrainCheck battery
Tidsramme: Up to 1 year
|
Will be calculated along with a 95% CI. |
Up to 1 year
|
|
Average time to complete the pen and paper assessment
Tidsramme: Up to 1 year
|
Will be calculated along with a 95% CI. |
Up to 1 year
|
|
Difference in completion rate between the BrainCheck battery and paper and pen assessment
Tidsramme: Up to 1 year
|
Will be calculated along with 95% CIs. |
Up to 1 year
|
|
Difference in time to completion between the BrainCheck battery and the pen and paper assessment
Tidsramme: Up to 1 year
|
Will be calculated along with 95% CIs. |
Up to 1 year
|
|
Difference in score between the BrainCheck battery and the pen and paper assessments
Tidsramme: Up to 1 year
|
Will be calculated along with 95% CIs. |
Up to 1 year
|
|
Sensitivity, specificity, negative predictive value, positive predictive value, and accuracy of the electronic battery compared to the validated St. Louis University Mental Status Examination (SLUMS)
Tidsramme: Up to 1 year
|
Will be calculated along with 95% CIs. |
Up to 1 year
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Timothy Newhook, MD, M.D. Anderson Cancer Center
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2018-0093
- 2018-0093 (Annen identifikator: M D Anderson Cancer Center)
- NCI-2018-01895 (Registeridentifikator: CTRP (Clinical Trial Reporting Program))
Legemiddel- og utstyrsinformasjon, studiedokumenter
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