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Trial registered on ANZCTR


Registration number
ACTRN12615000919516
Ethics application status
Not yet submitted
Date submitted
19/05/2015
Date registered
2/09/2015
Date last updated
4/01/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of an integrated cognitive and sensory program in a residential aged care setting- a second pilot study.
Scientific title
Trialling a tailored care planning and care staff education program to reduce the behavioural and psychological symptoms experienced by residents living in a residential aged care facility.
Secondary ID [1] 286753 0
Nil
Universal Trial Number (UTN)
U1111-1170-2948
Trial acronym
ICSP NH pilot
Linked study record

Health condition
Health condition(s) or problem(s) studied:
behavioural and psychological symptoms 295113 0
caregiver knowledge and behaviour 295120 0
Condition category
Condition code
Neurological 295363 295363 0 0
Dementias
Mental Health 296313 296313 0 0
Anxiety
Mental Health 296314 296314 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1- residents:
- detailed assessment of cognitive abilities, sensory preferences and life and trauma history. Cognitive abilities assessed with Large Allen’s Cognitive Level Screen (LACLS); sensory preferences and life and trauma history by questionnaire.
- tailored care planning using the information from above assessments, with the objective of providing strategies for staff to use to prevent and manage behavioural and psychological symptoms during activities of daily living.
- duration of intervention: 4 months.
- mode of administration: one-on-one consultation.
- person administering intervention: occupational therapist.

Arm 2- paid caregivers:
- education program which aims to increase their understanding of functional cognition according to the Allen’s Cognitive Disability Model; sensory modulation principles and interventions; and how to adjust caregiving according to individual residents’ life and trauma experiences.
- weekly micro training sessions where information from resident assessments is shared and strategies developed for issues in care. The objective of this is to provide strategies for staff to use to prevent and manage behavioural and psychological symptoms during activities of daily living.
- duration of intervention: 4 months.
- mode of administration: one-on-one consultation.
- person administering intervention: occupational therapist.

Only staff intervention will require monitoring for adherence. Descriptive counts will be kept of the training sessions, durations, and topics covered, and staff attendance at training. Staff will be invited to participate in group interviews and a care file audit will also be conducted to explore other behaviour changes and the frequency and type of interventions offered by staff to residents.
Intervention code [1] 291908 0
Behaviour
Intervention code [2] 292665 0
Prevention
Intervention code [3] 292666 0
Treatment: Other
Comparator / control treatment
No control treatment as this is a single group trial.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 295106 0
Resident participants: mean score of the domains of agitation, anxiety, irritability, apathy and occupational disruptiveness, using the Neuropsychiatric Inventory- Nursing Home version.
Timepoint [1] 295106 0
Baseline and after 4 months of intervention.
Primary outcome [2] 295924 0
Care staff participants: mean score in a knowledge test consisting of 4 Likert-type questions regarding the cognitive, sensory and trauma-related needs of residents.
Timepoint [2] 295924 0
Baseline and after 4 months of intervention.
Secondary outcome [1] 314784 0
Resident participants: mean Total score of behavioural and psychological symptoms using the Neuropsychiatric Inventory- Nursing Home version.
Timepoint [1] 314784 0
Baseline and after 4 months of intervention.
Secondary outcome [2] 316936 0
Care staff participants: ability to identify, anticipate and address triggers of resident behavioural and psychological symptoms.
Qualitative and quantitative data will be used for this as process evaluation. Descriptive counts will be kept of the training sessions, durations, and topics covered, and staff attendance at training. Staff will be invited to participate in group interviews and a care file audit will also be conducted to explore other behaviour changes and the frequency and type of interventions offered by staff to residents.
Timepoint [2] 316936 0
Baseline and after 4 months of intervention.

Eligibility
Key inclusion criteria
Residents: live in the Randwick Nursing Home of SMMJH; they or their person responsible are able to read and communicate in the English language; consent to participate.
Caregivers: work in the Randwick Nursing Home of SMMJH; are able to read, write and communicate in the English language; consent to participate.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Residents: refusal to participate/withdrawal from study; death.
Caregivers: refusal to participate/withdrawal from study; cease employment in the Nursing Home.

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



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be entered in Excel and then imported into SPSS for analysis. Repeated measures analysis of variance will be used to examine resident and staff outcomes after the 4 months intervention compared to baseline. The hypothesis for the study in relation to the resident sample is that there will be a significant reduction in NPI-NH scores from pre- to post- implementation for the subscales of agitation, anxiety, irritability, apathy and occupational disruptiveness. The hypothesis for the study in relation to the care staff sample is that there will be a significant increase in self-reported knowledge from pre- to post- implementation.
The power analysis for one sided t test using a sample size of 109 residents indicates the study will be powered at .92 (alpha = .05, effect size = 0.3). Power analyses conducted using Gpower10 suggest 93% power for a repeated measures ANOVA with alpha set at 0.05, an effect size of 0.2 and a correlation between repeated measures of 0.3.

Care staff focus groups will be recorded and transcribed. Thematic analysis will be conducted using NVIVO focusing on barriers and reported changes in staff attitudes and behaviours and impact on residents. Care file audits data will also be qualitatively analysed.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
The study design changed and this registered trial cannot be updated due to the changes being so significant, therefore a new registration will be completed.
Date of first participant enrolment
Anticipated
8/02/2016
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
109
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 10202 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 291297 0
Other
Name [1] 291297 0
Sir Moses Montefiore Jewish Home
Country [1] 291297 0
Australia
Funding source category [2] 291900 0
University
Name [2] 291900 0
Centre for Health Brain Ageing (CHeBA)
University of NSW
Country [2] 291900 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Lee-Fay Low
Address
M309B Ageing Work & Health Research Unit
Faculty of Health Sciences
University of Sydney
75 East St
Lidcombe NSW 2141
Country
Australia
Secondary sponsor category [1] 289973 0
Individual
Name [1] 289973 0
Sofia Venuti
Address [1] 289973 0
Ageing Work & Health Research Unit
Faculty of Health Sciences
University of Sydney
75 East St
Lidcombe NSW 2141
Country [1] 289973 0
Australia
Secondary sponsor category [2] 289974 0
Individual
Name [2] 289974 0
Professor Lindy Clemson
Address [2] 289974 0
Ageing Work & Health Research Unit
Faculty of Health Sciences
University of Sydney
75 East St
Lidcombe NSW 2141
Country [2] 289974 0
Australia
Secondary sponsor category [3] 289975 0
Individual
Name [3] 289975 0
Scientia Professor Henry Brodaty
Address [3] 289975 0
Centre for Healthy Brain Ageing
Room 302b, AGSM
UNSW Sydney 2052
Country [3] 289975 0
Australia
Other collaborator category [1] 278593 0
Individual
Name [1] 278593 0
Jacqueline Wesson
Address [1] 278593 0
Ageing, Work & Health Research Unit
Faculty of Health Sciences
75 East St
Lidcombe NSW 2141
Country [1] 278593 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 292864 0
University of Sydney
Ethics committee address [1] 292864 0
Ethics committee country [1] 292864 0
Australia
Date submitted for ethics approval [1] 292864 0
07/09/2015
Approval date [1] 292864 0
Ethics approval number [1] 292864 0

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

Contacts
Principal investigator
Name 57402 0
A/Prof Lee-Fay Low
Address 57402 0
M309B
Ageing, Work & Health Research Unit
Faculty of Health Sciences
75 East St
Lidcombe NSW 2141
Country 57402 0
Australia
Phone 57402 0
+61 2 9036 7968
Fax 57402 0
Email 57402 0
lee-fay.low@sydney.edu.au
Contact person for public queries
Name 57403 0
Sofia Venuti
Address 57403 0
Montefiore Home
36 Dangar Street
Randwick NSW 2031
Country 57403 0
Australia
Phone 57403 0
+61 2 8345 9164
Fax 57403 0
Email 57403 0
svenuti@montefiorehome.com.au
Contact person for scientific queries
Name 57404 0
Lee-Fay Low
Address 57404 0
M309B
Ageing, Work & Health Research Unit
Faculty of Health Sciences
75 East St
Lidcombe NSW 2141
Country 57404 0
Australia
Phone 57404 0
+61 2 9036 7968
Fax 57404 0
Email 57404 0
lee-fay.low@sydney.edu.au

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

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

Documents added automatically
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