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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01650896
Registration number
NCT01650896
Ethics application status
Date submitted
10/07/2012
Date registered
26/07/2012
Date last updated
26/07/2012
Titles & IDs
Public title
Prospective Randomised Controlled Trial of Delirium Management by Geriatric Medicine Versus General Medicine
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Scientific title
Prospective Randomised Controlled Trial of Delirium Management The Central Coast Australia Delirium Intervention Study (CADIS
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Secondary ID [1]
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CADIS-2012
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Universal Trial Number (UTN)
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Trial acronym
CADIS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Delirium
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Condition category
Condition code
Neurological
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Other neurological disorders
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Mental Health
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Other mental health disorders
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Mental Health
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0
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Psychosis and personality disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Geriatric assessment review
No intervention: General Medicine -
Active comparator: Geriatric Medicine - Daily medical review, adjust medications, treat infection, occupational therapy
Other interventions: Geriatric assessment review
Adjust medications, treat precipitants of delirium, one-on-one supervision of agitated violent patients
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Return home rate
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Assessment method [1]
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The percentage of subjects returning home divided by the number living at home prior to admission and surviving until discharge
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Timepoint [1]
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10-50 days
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Primary outcome [2]
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Survival
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Assessment method [2]
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Surivors divided by subjects reaching that milestone
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Timepoint [2]
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30, 90, 180 days, 12 and 24 month
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Primary outcome [3]
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Percentage residing at home
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Assessment method [3]
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Number of subjects at home divided by number surviving to that milesone
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Timepoint [3]
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30, 90 and 180 days, 12 and 24 months
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Primary outcome [4]
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Hospital complications of delirium
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Assessment method [4]
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Absconding from ward, physical violence, pulling out intravenous lines and indwelling catheters, refusing medications, falls and injurious falls
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Timepoint [4]
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7-50 days from admission
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Eligibility
Key inclusion criteria
age 65+ medical admissions from emergency department with CAM positive delirium who have an informant / caregiver -
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Minimum age
65
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1)Aphasia; 2) Unable to speak English; 3) End stage dementia; 4) Terminal care; 5) No close informant; 6) Unable to hear questions with or without portable amplifier with headphones; 7) Intensive care; 8) Surgical admissions
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
UNKNOWN
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/07/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/07/2016
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Actual
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Sample size
Target
250
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Wyong Hospital - Kanwal
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Recruitment postcode(s) [1]
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2263 - Kanwal
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Funding & Sponsors
Primary sponsor type
Other
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Name
Central Coast Local Health District
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The typical delirium study between 1989 and 2005 compared delirium management in a specialty unit such as geriatric medicine with delirium management in general medicine (in most cases the research diagnosis of delirium was not communicated to the general medicine group). This study will provide open diagnosis of delirium by the CAM to both the geriatric medicine and general medicine groups (medical staff, patients, families) plus daily monitoring of delirium using digit span and delirium index which is reported to both patient groups. It will also compare confusion assessment method (CAM)to a novel diagnostic system of Paul Regal with respect to hard endpoints (survival and return home). Hypotheses: 1) General medicine can manage delirium as well as geriatric medicine when delirium is openly diagnosed and monitored daily (even in speciality units it is rare to find daily measurement of tools such as delirium index); 2) The Regal diagnostic system will be superior to the CAM in predicting hard endpoints (survival and return home rate for patients living in the community).
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Trial website
https://clinicaltrials.gov/study/NCT01650896
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Aileen Carter, BSc
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Address
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Country
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Phone
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612 43948000
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Fax
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Email
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[email protected]
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT01650896
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