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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
Scientific title
Prospective Randomised Controlled Trial of Delirium Management The Central Coast Australia Delirium Intervention Study (CADIS
Secondary ID [1] 0 0
CADIS-2012
Universal Trial Number (UTN)
Trial acronym
CADIS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Delirium 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Mental Health 0 0 0 0
Other mental health disorders
Mental Health 0 0 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Return home rate
Timepoint [1] 0 0
10-50 days
Primary outcome [2] 0 0
Survival
Timepoint [2] 0 0
30, 90, 180 days, 12 and 24 month
Primary outcome [3] 0 0
Percentage residing at home
Timepoint [3] 0 0
30, 90 and 180 days, 12 and 24 months
Primary outcome [4] 0 0
Hospital complications of delirium
Timepoint [4] 0 0
7-50 days from admission

Eligibility
Key inclusion criteria
age 65+ medical admissions from emergency department with CAM positive delirium who have an informant / caregiver -
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

-

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2016
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Wyong Hospital - Kanwal
Recruitment postcode(s) [1] 0 0
2263 - Kanwal

Funding & Sponsors
Primary sponsor type
Other
Name
Central Coast Local Health District
Address
Country

Ethics approval
Ethics application status

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).
Trial website
https://clinicaltrials.gov/study/NCT01650896
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Aileen Carter, BSc
Address 0 0
Country 0 0
Phone 0 0
612 43948000
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01650896