Elektroniska neurokognitiva verktyg vid screening för mental förmåga hos patienter som genomgår leverkirurgi
En genomförbarhetsstudie av elektroniska neurokognitiva screeningverktyg inom 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Texas
-
Houston, Texas, Förenta staterna, 77030
- M D Anderson Cancer Center
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Enhetens genomförbarhet
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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
Andra namn:
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
Andra namn:
Receive pen and paper cognitive assessment |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Completion rate of the BrainCheck battery
Tidsram: 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
Tidsram: Up to 1 year
|
Will be calculated along with a 95% CI. |
Up to 1 year
|
|
Average time to complete the BrainCheck battery
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: Up to 1 year
|
Will be calculated along with 95% CIs. |
Up to 1 year
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Timothy Newhook, MD, M.D. Anderson Cancer Center
Publikationer och användbara länkar
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2018-0093
- 2018-0093 (Annan identifierare: M D Anderson Cancer Center)
- NCI-2018-01895 (Registeridentifierare: CTRP (Clinical Trial Reporting Program))
Läkemedels- och apparatinformation, studiedokument
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