- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02258386
Assessment of Delirium in Hospitalized Patients
Objective Assessment of Delirium in Hospitalized Patients
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
After obtaining written informed consent and Protected Health Information (PHI) consent, CAM-ICU (Confusion Assessment Method for the ICU) will be measured routinely by unit nurses each shift. Results will be available in the medical record. We will then measure physical activity and physiological measures (e.g. ECG, heart rate, respiration rate, and body temperature) using an unobtrusive body worn sensor. This sensor will be attached to the 5th intercostal space using a specifically designed patch (BioPatchTM) to allow quantification of physical activity such as walking, standing, sitting, lying, as well as measurement of other physiological parameters. These measurements will only be available to the research team and will not be available to the nurses on the inpatient study unit. Medical history (from clinic chart) and demographic information will be obtained, such as age, gender, weight, and height as well as details (e.g. injuries, fall score and number of falls) which happened during hospital stay. The research tests consist of one core measurements and one ancillary measurements (as required) as listed below (Note - ancillary measurement may not be required for everyone).
Core measurements Assessment of physical activity and physiological measures: Patients will be asked to wear the Zephyr BioModule for a period of 24 hours to maximum stay in the hospital. The Zephyr BioModule will be attached to the patients to the 5th intercostal space using a specifically designed patch (BioPatchTM).
Ancillary Measurements Upper Extremity Test: A validated body worn sensors (LEGSys™, Biosensics LLC) will be used to evaluate upper extremity kinematics (angular velocities). This is a simple test where the patient flexes and extends their arm for 20 seconds on each arm.
Analysis plan:
To predict the risk of delirium using physical activity and physiological data, each patient participating in the study will be categorized as to presence of delirium based on CAM-ICU questionnaire. Logistic regression analysis will be used to examine the relation between each physical activity variable (e.g. lying time) and physiological measures (e.g. heart rate) with delirium risk. Firstly, univariate logistic regression, using presence of delirium as the dependent variable, will be employed to investigate the relationship of the test variables. The Odd Ratios (OR) and coefficient of determination (R2) will be calculated for each explanatory variable. Then multivariate logistic regression using stepwise-automated methods will be performed to investigate the independent effects of the physical activity variables and physiological measures in predicting delirium. Sensitivities, specificities, positive and negative predictive values of different cut-off values will be calculated for any non-categorical variable shown to have an independent effect on predicting delirium. A two-sided P-value ≤0.05 will be considered to be statistically significant. Statistical analysis will be performed using SPSS (Statistical Package for the Social Sciences) statistics 22.0 (IBM, Armonk (name of town), NY (New York), USA).
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria: At least one of the following:
- Cognitive impairment,
- UTI (urinary tract infection)
- Pneumonia,
Status post hip fracture or trauma,
->5 medications,
- Previous hospitalization in past 6 months
Exclusion Criteria:
- Refusal to participate
- Terminally ill
- On ventilator
- Delirium based on CAM-ICU
Studieplan
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Objective Assessment of Delirium in Hospitalized Patients
Tidsram: 3 years
|
To identify biodata (physiological measurement) patterns indicative of the 3 subtypes of delirium (hypoactive, hyperactive and mixed).
To build an algorithm sensitive and specific to the diagnosis of each of the three subtypes of delirium for future integration into a delirium monitoring system capable of objective delirium diagnosis, concentrating on those patterns indicative of early identification.
|
3 years
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Jane Mohler, PhD, University of Arizona
Publikationer och användbara länkar
Allmänna publikationer
- Cole MG. Delirium in elderly patients. Am J Geriatr Psychiatry. 2004 Jan-Feb;12(1):7-21.
- Leslie DL, Zhang Y, Holford TR, Bogardus ST, Leo-Summers LS, Inouye SK. Premature death associated with delirium at 1-year follow-up. Arch Intern Med. 2005 Jul 25;165(14):1657-62. doi: 10.1001/archinte.165.14.1657.
- McCusker J, Cole M, Dendukuri N, Belzile E, Primeau F. Delirium in older medical inpatients and subsequent cognitive and functional status: a prospective study. CMAJ. 2001 Sep 4;165(5):575-83.
- Gleason OC. Delirium. Am Fam Physician. 2003 Mar 1;67(5):1027-34.
- Foreman MD, Wakefield B, Culp K, Milisen K. Delirium in elderly patients: an overview of the state of the science. J Gerontol Nurs. 2001 Apr;27(4):12-20. doi: 10.3928/0098-9134-20010401-06.
- Inouye SK. The dilemma of delirium: clinical and research controversies regarding diagnosis and evaluation of delirium in hospitalized elderly medical patients. Am J Med. 1994 Sep;97(3):278-88. doi: 10.1016/0002-9343(94)90011-6.
- Francis J. Delirium in older patients. J Am Geriatr Soc. 1992 Aug;40(8):829-38. doi: 10.1111/j.1532-5415.1992.tb01859.x. No abstract available.
- Albert MS, Levkoff SE, Reilly C, Liptzin B, Pilgrim D, Cleary PD, Evans D, Rowe JW. The delirium symptom interview: an interview for the detection of delirium symptoms in hospitalized patients. J Geriatr Psychiatry Neurol. 1992 Jan-Mar;5(1):14-21. doi: 10.1177/002383099200500103.
- Trzepacz PT, Baker RW, Greenhouse J. A symptom rating scale for delirium. Psychiatry Res. 1988 Jan;23(1):89-97. doi: 10.1016/0165-1781(88)90037-6.
- O'Keeffe S, Lavan J. The prognostic significance of delirium in older hospital patients. J Am Geriatr Soc. 1997 Feb;45(2):174-8. doi: 10.1111/j.1532-5415.1997.tb04503.x.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- IRB #1409472204
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Kliniska prövningar på Delirium
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Efficacy Care R&D LtdHadassah Medical OrganizationOkändDelirium | Delirium, orsak okänd | Delirium av blandat ursprung | Delirium Förvirringstillstånd | Läkemedelsinducerad deliriumIsrael
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Johns Hopkins UniversityNational Institute on Aging (NIA)Aktiv, inte rekryterandeDelirium | Delirium vid uppkomst | Hörselnedsättning | Hörselnedsättning, högfrekvent | Hörselnedsättning, sensorineural | Delirium, orsak okänd | Hörselnedsättning, bilateral | Hörselnedsättning | Delirium i ålderdom | Delirium av blandat ursprung | Delirium överlagrat på demens | Delirium Förvirringstillstånd | Delirium... och andra villkorFörenta staterna
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Oslo University HospitalUniversity of Melbourne; Norwegian Academy of MusicAvslutadDelirium i ålderdom | Delirium av blandat ursprung | Delirium överlagrat på demens | Delirium FörvirringstillståndNorge
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Universidad de SantanderOkändDelirium av blandat ursprung | Hypoaktivt delirium | Hyperaktivt deliriumColombia
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Imperial College Healthcare NHS TrustRekryteringHjärtkirurgi | Intensivvårdsavdelning Delirium | Postoperativt deliriumStorbritannien
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Chinese PLA General HospitalBeijing Tiantan HospitalRekrytering
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Charite University, Berlin, GermanyBARMERRekryteringDelirium i ålderdomTyskland
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Qin ZhangNational Natural Science Foundation of ChinaRekrytering
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Qin ZhangNational Natural Science Foundation of ChinaRekryteringDelirium, postoperativtKina
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University Hospital, Basel, SwitzerlandInnosuisse - Swiss Innovation AgencyRekryteringPostoperativt delirium (POD)Schweiz