Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000417482
Ethics application status
Approved
Date submitted
15/03/2007
Date registered
17/08/2007
Date last updated
24/01/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Dementia in residential care: education intervention trial
Scientific title
Improving quality of life of people with dementia living in residential care facilities: a randomised trial of an educational strategy developed using action research. The educational strategy will be developed in the initial qualitative phase of the study, and thus informed by the needs of participants
Secondary ID [1] 279787 0
458797
Universal Trial Number (UTN)
Trial acronym
DIRECT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 2135 0
Condition category
Condition code
Neurological 2231 2231 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Education delivered to general practitioners and staff caring for people with dementia living in residential care facilities. The educational intervention will be developed in the initial phase of the study using 'action research'. The study includes an intial one year qualitative phase, a one year intervention phase, and one year follow up.
Intervention code [1] 1981 0
Other interventions
Comparator / control treatment
Control GPs and staff will receive no additional education.
Control group
Active

Outcomes
Primary outcome [1] 3092 0
Quality of life
Timepoint [1] 3092 0
6 weeks and 6 months after conclusion of intervention
Secondary outcome [1] 5175 0
Knowledge among GPs and residential care facility (RCF) staff regarding dementia, its management and appropriate use of psychotropic pharmacotherapy; use of chemical and non-chemical restraint ; Behavioural and Psychologic Symptoms of Dementia, functional state and mobility; carer satisfaction; Emergency medical reviews; mood; Pain; environmental quality; Sleep Quality.
Timepoint [1] 5175 0
6 weeks and 6 months after conclusion of intervention

Eligibility
Key inclusion criteria
Permanent resident of a low-level or high-level residential care facility, greater than 65 years of age with mimi mental state examination (MMSE) score <24. Subject (if able to give consent), their General Practitioner and surrogate (the “next of kin” or other identified proxy) consent to trial participation.
Minimum age
65 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
subject is identified by facility staff as medically unstable or as suffering delirium, or in the terminal stages of a co-morbid illness; subject unable to complete assessment instruments in English.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be by centrally held randomisation table
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation tables will be used to independently randomise General Practitioners and residential facilities to the intervention or control
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Assessors blinded to intervention
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
364
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2391 0
Government body
Name [1] 2391 0
NHMRC
Country [1] 2391 0
Australia
Primary sponsor type
University
Name
University of Western Australia
Address
Stirling Hwy
CRAWLEY WA 6009
Country
Australia
Secondary sponsor category [1] 2166 0
None
Name [1] 2166 0
None
Address [1] 2166 0
Country [1] 2166 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4218 0
UWA
Ethics committee address [1] 4218 0
Ethics committee country [1] 4218 0
Australia
Date submitted for ethics approval [1] 4218 0
Approval date [1] 4218 0
Ethics approval number [1] 4218 0

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

Contacts
Principal investigator
Name 27585 0
Address 27585 0
Country 27585 0
Phone 27585 0
Fax 27585 0
Email 27585 0
Contact person for public queries
Name 10840 0
Christopher Beer
Address 10840 0
WA Centre for Health and Ageing
UWA Royal Perth Hospital
Country 10840 0
Australia
Phone 10840 0
08 9224 2750
Fax 10840 0
Email 10840 0
[email protected]
Contact person for scientific queries
Name 1768 0
Christopher Beer
Address 1768 0
WA Centre for Health and Ageing
UWA Royal Perth Hospital
WA
Country 1768 0
Australia
Phone 1768 0
08 9224 2750
Fax 1768 0
Email 1768 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
SourceTitleYear of PublicationDOI
Dimensions AIA Cluster-Randomised Trial of Staff Education to Improve the Quality of Life of People with Dementia Living in Residential Care: The DIRECT Study2011https://doi.org/10.1371/journal.pone.0028155
Dimensions AIUse of Potentially Harmful Medications and Health-Related Quality of Life among People with Dementia Living in Residential Aged Care Facilities2012https://doi.org/10.1159/000342172
N.B. These documents automatically identified may not have been verified by the study sponsor.