Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000753459
Ethics application status
Approved
Date submitted
8/04/2025
Date registered
16/07/2025
Date last updated
16/07/2025
Date data sharing statement initially provided
16/07/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cognitive Fluctuations in Delirium
Scientific title
Cognitive Fluctuations and Its Role in the Diagnosis of Delirium & Dementias in Nursing Homes
Secondary ID [1] 312474 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Delirium 336794 0
Dementia 336795 0
Condition category
Condition code
Neurological 333288 333288 0 0
Other neurological disorders
Neurological 333289 333289 0 0
Dementias

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study aims to better understand cognitive fluctuation in older people living in residential age care and how it relates to diagnosis of delirium and dementia. The study will first estimate the prevalence of delirium in older adults in three rural residential care facilities (Study 1). It will then compare the occurrence and characteristics of cognitive fluctuations in people with delirium with people with dementia but no delirium (Study 2). Consent will be obtained for both Study 1 and Study 2 at the outset.
Study 1 includes collection of data routinely collected by the residential aged facility for all older adults who have consented or for whom there is appropriate proxy consent. Following this, on a selected day 4AT will be administered. 4AT is an evidence-based bedside tool for rapid delirium screening that takes about 2 minutes to administer,
Study 2 will prospectively identify participants who may have delirium from the group of participants who have previously consented or have proxy consent. Following screening with 4AT a participant with delirium and a participant with dementia but no delirium will be assessed for arousal levels using Modified Richmond Agitation Sedation Scale (mRASS) every hour. mRASS is an observational instrument derived from the Richmond Agitation Sedation Scale that measures the states of arousal, from unarousable (-5) to combative (+4). If arousal level allows for attention assessment, then participants' attention will be assessed hourly (where permitting) using DelApp. Hourly assessments will occur over two consecutive days from 9 am to 6 pm to minimise impact on sleep.
Intervention code [1] 330628 0
Not applicable
Comparator / control treatment
No control group. Note that the study seeks to compare the occurrence and characteristics of cognitive fluctuations in people with delirium with people with dementia but no delirium. In Study 2, participants with dementia but no delirium will serve as the comparator group. So, arousal levels of participants with delirium will be compared to arousal levels of participants with dementia but no delirium. Arousal level measured by mRASS will be assessed hours from 9 am to 6 pm over two consecutive days. Should arousal levels permit assessment of attention, then level of attention as measured by DelApp will also be compared.
Control group
Active

Outcomes
Primary outcome [1] 342053 0
Delirium (Study 1)
Timepoint [1] 342053 0
One day assessment
Primary outcome [2] 342055 0
Arousal (Study 2)
Timepoint [2] 342055 0
Rated across two consecutive days every hour from 9 am on Day 1 until 6 pm the same day and again every hour from 9 am on Day 2 until 6 pm that day.
Secondary outcome [1] 449428 0
Attention (Study 2)
Timepoint [1] 449428 0
Rated across two consecutive days where arousal levels allow for attention assessment. If yes, then every hour from 9 am on Day 1 until 6 pm the same day and again every hour from 9 am on Day 2 until 6 pm that day.

Eligibility
Key inclusion criteria
1. Permanently placed older adults aged 65 years and over residing in one of the three residential aged care facilities of the study site.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Coma
2. Unable to consent or no proxy consent available.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Study 1: Descriptive statistics will be reported for all demographic and clinical variables.
For continuous data, group summary statistics will be compared using the independent samples t-test or the Wilcoxon rank sum test depending on its distribution.
For group comparisons on categorical variables, the chi-squared test will be used.
Study 2. The standard deviation (SD) of the ten 10-point scores will be calculated for each participant on each of the two days, and these SDs will be used as participant data for analysis of variability. The Delirium and Dementia groups will be compared using repeated measures ANOVA, with group as the between-subject factor and day as the within-subject factor. For analysis of the magnitude of the scores, the individual 10-point scores will be used as data to which a linear mixed model will be fitted. The random effects of this model will be participant and day nested within participant. The fixed effects will be group, day and hour of the day, and their interactions.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
7/07/2025
Date of last participant enrolment
Anticipated
29/09/2025
Actual
Date of last data collection
Anticipated
2/11/2025
Actual
Sample size
Target
150
Accrual to date
40
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 43887 0
3630 - Shepparton

Funding & Sponsors
Funding source category [1] 316890 0
Self funded/Unfunded
Name [1] 316890 0
Country [1] 316890 0
Primary sponsor type
University
Name
The University of Melbourne
Address
Country
Australia
Secondary sponsor category [1] 321059 0
None
Name [1] 321059 0
Address [1] 321059 0
Country [1] 321059 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315654 0
Goulburn Valley Health Human Research Ethics Committee
Ethics committee address [1] 315654 0
Ethics committee country [1] 315654 0
Australia
Date submitted for ethics approval [1] 315654 0
09/10/2019
Approval date [1] 315654 0
18/11/2019
Ethics approval number [1] 315654 0
HREC/58263/GVH-2019-192619(v2)

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135386 0
A/Prof Ravi Bhat
Address 135386 0
Divisional Clinical Director, Goulburn Valley Area Mental Health & Wellbeing Service, Monash Street, Shepparton, Victoria, 3630
Country 135386 0
Australia
Phone 135386 0
+61348044699
Fax 135386 0
Email 135386 0
[email protected]
Contact person for public queries
Name 135387 0
Ravi Bhat
Address 135387 0
Divisional Clinical Director, Goulburn Valley Area Mental Health & Wellbeing Service, Monash Street, Shepparton, Victoria, 3630
Country 135387 0
Australia
Phone 135387 0
+61348044699
Fax 135387 0
Email 135387 0
[email protected]
Contact person for scientific queries
Name 135388 0
Ravi Bhat
Address 135388 0
Divisional Clinical Director, Goulburn Valley Area Mental Health & Wellbeing Service, Monash Street, Shepparton, Victoria, 3630
Country 135388 0
Australia
Phone 135388 0
+61348044699
Fax 135388 0
Email 135388 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval    HREC58263GVH-2019-192619(v2).pdf


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.