Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12613001318774
Ethics application status
Not yet submitted
Date submitted
11/11/2013
Date registered
27/11/2013
Date last updated
27/11/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Does an education program for caregivers at a stage 3 dementia care facility improve the quality of life for the residents, thereby reducing the use of antipsychotic medications for behavioural symptoms of dementia?
Scientific title
In persons with moderate to severe dementia in stage 3 dementia care, does the person-centred approach of staff education and support, compared to the use of antipsychotics, reduce behavioural and psychological symptoms of dementia and reduce antipsychotic use?
Secondary ID [1] 283408 0
nil
Universal Trial Number (UTN)
U-1111-1149-0918
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Behavioural and Psychological Symptoms of Dementia 290318 0
Condition category
Condition code
Neurological 290717 290717 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
EDUCATION:

All members of staff at the facility will attend a half day training session. The education will be provided by nursing staff from our team.
It will cover what dementia is, how it affects the persons brain. How this translates to behaviours and how care staff can react to these behaviours, We will focus on Tom Kitwoods model of recognising the person behind the symptoms and use the Behavioural Staging Model to help staff recognise the different stages that people with dementia go through, with a corresponding change in our approach at a given stage.
There will be a focus on being aware of responding to clients needs as they arise with a shift away from 'care by the clock' We will present our individual assessment tool and guide designed for the project so that staff are guided through the Antecedent-Behaviour-Consequences (ABC) approach of functional analysis.

SUPPORT & GUIDANCE:
Once a week, for 2-3 hours a member of our team will attend the facility to review the behavioural assessment tools completed in that week. They will assist in the process of learning to problem solve why events occurred and which strategies might reduce these events occurring again. This will be carried out for 2 months. Outcome measures at 3 and 6 months.
Intervention code [1] 288132 0
Treatment: Other
Comparator / control treatment
Number of reported adverse incidents, observations from dementia care mapping, use of regular and 'as needed' antipsychotic use and use of neuropsychiatric inventory (NPI) before and after education program in the same patients. The patients therefore serve as their own controls.
Control group
Active

Outcomes
Primary outcome [1] 290718 0
Use of antipsychotics. We will review the use of regular and number of 'as needed' antipsychotics used for one month before the intervention then again at 3 and 6 months to determine a change in prescribing practice.
Timepoint [1] 290718 0
at 3 and 6 months
Primary outcome [2] 290719 0
DCM (Dementia Care Mapping) observation
Timepoint [2] 290719 0
at 3 and 6 months
Primary outcome [3] 290720 0
Incident reports of aggression. We will review the number of incident reports logged before and after the intervention
Timepoint [3] 290720 0
at 3 and 6 months
Secondary outcome [1] 305092 0
NPI scores
Timepoint [1] 305092 0
at 3 and 6 months and re-audit at one year

Eligibility
Key inclusion criteria
Moderate to severe dementia in patients at a particular stage 3 rest home
Minimum age
50 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Lack of proxy consent.

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)
All patients will be subject to the intervention so there is no allocation concealment
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
n/a
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Patients serve as their own controls. There is no need for a washout period as the patients will not be taking any medications as an intervention.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We are seeking statistical support from Chris Frampton at Otago University. Our sample size is one of pragmatic convenience, i.e. all those consenting at the one site. the study aims to establish some initial signal of acceptance and feasibility of our suggested education programme, as well as effectiveness albeit to a lesser degree.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/02/2014
Actual
Date of last participant enrolment
Anticipated
4/03/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
18
Accrual to date
Final
Recruitment outside Australia
Country [1] 5519 0
New Zealand
State/province [1] 5519 0
Bay of Plenty

Funding & Sponsors
Funding source category [1] 288133 0
Self funded/Unfunded
Name [1] 288133 0
Country [1] 288133 0
Primary sponsor type
Individual
Name
Bhamini Patel
Address
Tauranga Hospital
Private Bag 12024
Tauranga 3110
New Zealand
Country
New Zealand
Secondary sponsor category [1] 286848 0
Individual
Name [1] 286848 0
Bronwyn Copeland
Address [1] 286848 0
Tauranga Hospital
Private Bag 12024
Tauranga 3110
New Zealand
Country [1] 286848 0
New Zealand
Other collaborator category [1] 277653 0
Individual
Name [1] 277653 0
Andrew Wilkinson
Address [1] 277653 0
Tauranga Hospital
Private Bag 12024
Tauranga 3110
New Zealand
Country [1] 277653 0
New Zealand
Other collaborator category [2] 277654 0
Individual
Name [2] 277654 0
Kerry Capelin
Address [2] 277654 0
Tauranga Hospital
Private Bag 12024
Tauranga 3110
New Zealand
Country [2] 277654 0
New Zealand
Other collaborator category [3] 277655 0
Individual
Name [3] 277655 0
Rosalie Pretorius
Address [3] 277655 0
Tauranga Hospital
Private Bag 12024
Tauranga 3110
New Zealand
Country [3] 277655 0
New Zealand
Other collaborator category [4] 277656 0
Individual
Name [4] 277656 0
Lisa Rogers-Owens
Address [4] 277656 0
Tauranga Hospital
Private Bag 12024
Tauranga 3110
New Zealand
Country [4] 277656 0
New Zealand
Other collaborator category [5] 277657 0
Individual
Name [5] 277657 0
Priscilla Kuzmanov
Address [5] 277657 0
Tauranga Hospital
Private Bag 12024
Tauranga 3110
New Zealand
Country [5] 277657 0
New Zealand
Other collaborator category [6] 277658 0
Individual
Name [6] 277658 0
Ruth Thomas
Address [6] 277658 0
Tauranga Hospital
Private Bag 12024
Tauranga 3110
New Zealand
Country [6] 277658 0
New Zealand
Other collaborator category [7] 277659 0
Individual
Name [7] 277659 0
Dawn Wilson
Address [7] 277659 0
Tauranga Hospital
Private Bag 12024
Tauranga 3110
New Zealand
Country [7] 277659 0
New Zealand

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 290046 0
HDEC (Health and Disability Ethics Committee)
Ethics committee address [1] 290046 0
Ministry of Health
No 1 The Terrace
PO Box 5013
Wellington
Ethics committee country [1] 290046 0
New Zealand
Date submitted for ethics approval [1] 290046 0
20/11/2013
Approval date [1] 290046 0
Ethics approval number [1] 290046 0

Summary
Brief summary
Study hypothesis: Does use of an education program for caregivers of staff in stage 3 dementia care reduce use of antipsychotics for the behavioural and psychological symptoms of dementia and decrease the frequency of adverse incidents?
Trial website
n/a
Trial related presentations / publications
n/a
Public notes
n/a

Contacts
Principal investigator
Name 43690 0
Dr Bhamini Patel
Address 43690 0
Tauranga Hospital
Private Bag 12024
Tauranga 3110
Country 43690 0
New Zealand
Phone 43690 0
+64 7 579 8335
Fax 43690 0
Email 43690 0
[email protected]
Contact person for public queries
Name 43691 0
Rosalie Pretorius
Address 43691 0
Tauranga Hospital
Private Bag 12024
Tauranga 3110
Country 43691 0
New Zealand
Phone 43691 0
+64 7 579 8335
Fax 43691 0
Email 43691 0
[email protected]
Contact person for scientific queries
Name 43692 0
Bhamini Patel
Address 43692 0
Tauranga Hospital
Private Bag 12024
Tauranga 3110
Country 43692 0
New Zealand
Phone 43692 0
+64 7 579 8335
Fax 43692 0
Email 43692 0
[email protected]

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
No additional documents have been identified.