ANZCTR - Registration

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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]

458797

Universal Trial Number (UTN)

Trial acronym

DIRECT

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Dementia

Condition category

Condition code

Neurological

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]

Other interventions

Comparator / control treatment

Control GPs and staff will receive no additional education.

Control group

Active

Outcomes

Primary outcome [1]

Quality of life

Timepoint [1]

6 weeks and 6 months after conclusion of intervention

Secondary outcome [1]

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]

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?

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]

Government body

Name [1]

NHMRC

Address [1]

Canberra

Country [1]

Australia

Primary sponsor type

University

Name

University of Western Australia

Address

Stirling Hwy
CRAWLEY WA 6009

Country

Australia

Secondary sponsor category [1]

None

Name [1]

None

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

UWA

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

The DIRECT study aims to determine if education of General Practitioners (GPs) and Residential Care Staff can improve the quality of life (QOL) of people with dementia living in Residential Care Facilities (RCF). Our hypothesis is that a systematic educational intervention delivered to GPs and RCF staff will improve care delivery, leading to measurable improvements in the quality of life of residential care recipients. We hypothesise that education delivered to GPs will have additive effects to education delivered to RCF staff.

Dementia is the leading cause of non-fatal disease burden among older Australians. Of people with dementia, nearly half live in RCF.  There appears to be much scope to improve care, and thus QOL, for people with dementia living in residential facilities. However, the most effective way to translate knowledge regarding the components of high quality care into practice is uncertain and there is a paucity of Australian data to guide practice.  Education of RCF staff is likely to be the cornerstone of improved care for recipients of residential care who have dementia.  GPs also play a key-role in the care of older people living in RCF, including collaboration in the development of management plans, prescription of medications and initiation of health referrals.

A detailed action research process with data collected from surveys, focus groups and pilots will be used to develop educational programmes for delivery to GPs and RCF staff. The primary outcome of the study will be quality of life of the people with dementia, assessed by themselves, their family carers and the staff looking after them.  Several tools incorporating different sources of information will be used to assess QOL in a comprehensive fashion. Secondary outcomes will include knowledge among GPs and RCF staff regarding dementia, markers of quality care, participants’ sleep quality, and carer satisfaction. It is anticipated that the results will fill this current gap in evidence and will be of value to policy makers and stakeholders from the Residential Care Industry and Peak Community and General Practice bodies.  The study results will have tangible implications for proprietors, managers and staff from the residential care sector and policy makers.  The results have potential to directly benefit the quality of life of both patients and carers.

Trial website

Trial related presentations / publications

Beer CD, Barbara Horner B, Almeida OP, Scherer S, Lautenschalger NT, Bretland N, Flett P, Schaper F and Flicker L. Dementia in residential care: education intervention trial (DIRECT); protocol for a randomised controlled trial. Trials 2010, 11:63

Beer C, Flicker L. Horner B, Bretland N, Scherer S, Lautenschlager NT, Schaper F, Almeida OP. Factors Associated with Self and Informant Ratings of the Quality of Life of People with Dementia Living in Care Facilities: a Cross Sectional Study. PLoS One. 2010; 5(12):e15621

Beer C, Horner B, Flicker L, Scherer S, Lautenschlager NT, Bretland N, Flett P, Schaper F & Almeida OP. A cluster-randomised trial of staff education to improve the quality of life of people with dementia living in residential care: the DIRECT study. PLoS One 2011;6(11):e28155

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Christopher Beer

Address

WA Centre for Health and Ageing
UWA Royal Perth Hospital

Country

Australia

Phone

08 9224 2750

Fax

cdbeer@graduate.uwa.edu.au

Contact person for scientific queries

Name

Christopher Beer

Address

WA Centre for Health and Ageing
UWA Royal Perth Hospital
WA

Country

Australia

Phone

08 9224 2750

Fax

cdbeer@graduate.uwa.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

Source	Title	Year of Publication	DOI
Dimensions AI	A Cluster-Randomised Trial of Staff Education to Improve the Quality of Life of People with Dementia Living in Residential Care: The DIRECT Study	2011	https://doi.org/10.1371/journal.pone.0028155
Dimensions AI	Use of Potentially Harmful Medications and Health-Related Quality of Life among People with Dementia Living in Residential Aged Care Facilities	2012	https://doi.org/10.1159/000342172

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically