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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.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
ACTRN12607000344493
Ethics application status
Not yet submitted
Date submitted
14/06/2007
Date registered
26/06/2007
Date last updated
26/06/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
A comparison of intensive individualised behavioural support and traditional medical treatment for the behavioural and psychological symptoms of dementia (BPSD).
Scientific title
In aged care residents with dementia does intensive individualised behavioural support produce better outcomes than traditional medical treatment alone for the management of BPSD?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
The behavioural and psychological symptoms of dementia (BPSD) 1895 0
Condition category
Condition code
Neurological 1990 1990 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group 1 participants will receive the study intervention:- intensive individualised behavioural support. This will comprise a behavioural assessment and development of a behavioural plan, which will include interventions from at least some of the following categories: (a) Reactive strategies - strategies which provide situational management, (b) Proactive strategies - strategies such as environmental change, teaching new skills to participants or their carers, making adjustments to behavioural triggers and/or reinforcers. Participants in Group 1 will concurrently receive psychiatric assessment and treatment, as recommended by a Consultant Psychiatrist.
Intervention code [1] 1825 0
Behaviour
Comparator / control treatment
Group 2 participants will receive the control condition, which is traditional medical treatment. This will comprise psychiatric assessment and treatment, as recommended by a Consultant Psychiatrist. Case management will be provided by a Registered Psychiatric Nurse (RPN).
Outcome measures for both groups will be carried out between 8 and 10 weeks post baseline, at which time interventions are typically completed and clients are generally ready for discharge.
Control group
Active

Outcomes
Primary outcome [1] 2811 0
Reduction in the severity and frequency of BPSD and carer stress.
Timepoint [1] 2811 0
Measured at baseline, 8-10 weeks post baseline and at 6 months follow-up.
Primary outcome [2] 2812 0
Improvement in participant well-being.
Timepoint [2] 2812 0
Measured at baseline, 8-10 weeks post baseline and at 6 months follow-up.
Secondary outcome [1] 4737 0
Reduced use of medical services (GP visits, admissions to ED or psychiatric inpatient units).
Timepoint [1] 4737 0
The number of GP visits and admissions will be recorded for the 2 months prior to each measurement point (baseline, 8-10 weeks post baseline and 6 months follow-up).
Secondary outcome [2] 4738 0
Reduced use of psychotropic medication and medication side-effects.
Timepoint [2] 4738 0
Current psychotropic medications will be listed at each measurement point. Side-effects will be assessed from a file review for the 2 week period prior to each measurement point.

Eligibility
Key inclusion criteria
1. Participants will all have dementia, with a score of less than 24 on the Mini Mental State Examination (MMSE). 2.Participants will all present with at least one of the behavioural symptoms itemised on the Cohen-Mansfield Agitation Inventory (CMAI)3. Participants will all have informed consent to participate granted by their next of kin4. Participants will all reside in an aged care residential facility (high or low care)
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. MMSE score of 24 or above2. No behavioural symptoms itemised on the CMAI3. Informed consent not granted by next of kin4. Participant does not reside in an aged care residential facility

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)
One of the registered psychiatric nurses within BST has a dedicated role to assess each referral to the team for inclusion/exclusion criteria regarding the study. Once the participant is deemed eligible, an internally generated ID number is forwarded to an off-site researcher who then randomly allocates them to one of the treatment conditions based on coin tossing.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Coin tossing
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 2131 0
Hospital
Name [1] 2131 0
Eastern Health's Aged Persons Mental Health Service
Country [1] 2131 0
Australia
Primary sponsor type
Individual
Name
Dr Kuruvilla George, Consultant Psychiatrist and Director, Eastern Health's Aged Persons Mental Health Service
Address
Country
Australia
Secondary sponsor category [1] 1937 0
None
Name [1] 1937 0
N/A
Address [1] 1937 0
Country [1] 1937 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 3928 0
Eastern Health's Human Research Ethics Committee
Ethics committee address [1] 3928 0
Ethics committee country [1] 3928 0
Australia
Date submitted for ethics approval [1] 3928 0
Approval date [1] 3928 0
Ethics approval number [1] 3928 0

Summary
Brief summary
The project aims to investigate the most effective and efficient ways of providing treatment to patients with dementia and BPSD. The research team has previously carried out a preliminary pilot project, which suggested that intensive individualised behavioural interventions had beneficial effects in terms of reducing problem behaviours. However, there was no control or comparison groups, making it difficult to associate the reduction of behavioural problems with the psychosocial interventions, with any certainty.
The research team propose to contribute to research in this area by carrying out a group comparison study, comparing intensive indivdualised behavioural interventions with traditional medical treatment. Participants will all be patients referred to Eastern Health's Behaviour Support Team (BST) from aged care facilities with dementia and BPSD, where consent for participation has been given by next of kin. Information regarding the participants' behaviours, cognition, mental state, use of medications and medical services will be collected via observation, interview and questionnaires, involving both participants and their carers. Carers will also complete questionnaires regarding their perceptions of caring for participants. This information will be collected at baseline, post intervention and at 6-month follow-up. This information will serve as outcome data.
The two treatment conditions have been described earlier in this application. At the present time, there is no RCT evidence to support the efficacy of intensive behavioural programmes with this population, for these behavioural issues. It is anticipated that evidence regarding efficacy provided by this research would then be used to support proposals to increase resources to provide these interventions more widely.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27639 0
Address 27639 0
Country 27639 0
Phone 27639 0
Fax 27639 0
Email 27639 0
Contact person for public queries
Name 11014 0
Dr Catherine Hudgson
Address 11014 0
Peter James Centre
Suite 2
1st Floor
46 New Street
Ringwood VIC 3134
Country 11014 0
Australia
Phone 11014 0
+61 3 98811101
Fax 11014 0
+61 3 98794055
Email 11014 0
[email protected]
Contact person for scientific queries
Name 1942 0
Dr Catherine Hudgson
Address 1942 0
Peter James Centre
Suite 2
1st Floor
46 New Street
Ringwood VIC 3134
Country 1942 0
Australia
Phone 1942 0
+61 3 98811101
Fax 1942 0
+61 3 98794055
Email 1942 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.