Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000095369
Ethics application status
Approved
Date submitted
14/02/2008
Date registered
20/02/2008
Date last updated
10/08/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Person-Centred Environment and Care for Residents with Dementia.
Scientific title
Person-Centred Environment and Care for Residents with Dementia: a cost effective way to improve quality of life and quality of care.
Secondary ID [1] 262812 0
NONE
Universal Trial Number (UTN)
Trial acronym
PerCEN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 2840 0
Condition category
Condition code
Neurological 2973 2973 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Interventions using Person-centred care delivery according to Kitwood's care principles (PCC) and making adjustments to spatial configuration employing Kitwood's Person-centred dementia environment design (PCD).
(1) PCC - Experiential & adult learning approaches using Kitwood's PCC principles will be facilitated by 2 PCC trainers in a train-the-trainer course for 5 care staff (1*care manager, 1*RN, 2*EN/AINs, 1*Diversional Therapist) in each of the 10*PCC and 10*PCC+PCD units. This will take 32 hours over one week. PCC trained staff will, in turn be supported to train all care & therapy staff in PCC, we will provide them with individual learning resources, assist staff to develop PCC resident care plans that focus on improving resident's QOL. New staff will education. Further 10 hours of telephone support per site will be provided.
(2) PCD - to be implemented at each of the 10*PCD and 10*PCD+PCC sites. Two CI's will supervise two Masters' students in administering the Environment Audit Tool (EAT) as developed & validated by the two CI's to evaluate the relationshipsbetween operations & space in terms of effectiveness and ideal resident care & determining required changes to meet pCD principles at the sites. Discussions will be held with managers and care staff at each site to determine their understanding of the dysfunction generated by poor physical environments and changes will be planned with managers to address the issues identified. Minor modifications to the environment in each of the 20 sites will be undertaken under the supervison of the 2 CI's, to reduce the worst of the physical environmental effects, including: arranging objects & increasing natural light so that there is no confusion caused by the person's inability to distinguish foreground objects from nearbackground context; reducing the residents ability to distinguish a door or exit by painting-out in the wall or covered with curtain; not stimulating fear & frustration by avoiding dead-end situations; stimulating appropriate behaviours in spaces taht are made to deliberately look like dining, living & bedrooms; and adapting the style & type of furniture, colours & settings to provide cues that jog memory of appropriate behaviour.
Intervention code [1] 2570 0
Other interventions
Comparator / control treatment
Usual Care (UC) - standard care - is non-person centred care that is task focused & concerned mostly with physical care needs
Control group
Active

Outcomes
Primary outcome [1] 3848 0
Well being in the person with dementia will be evaluated by 1) DEMQoL and DEMQoL Proxy , 2) CMAI and 3) ERIC.
Timepoint [1] 3848 0
Follow-up will occur at 8 months
Primary outcome [2] 3849 0
Reduction in behaviourial & psychological symptoms of dementia. These will be measured by (1) CMAI - Cohen-Mansfield Agitation Inventory (2) ERIC - Emotional Responses in Care Assessment
Timepoint [2] 3849 0
Follow-up will occur at 8 months
Secondary outcome [1] 6482 0
Quality of care will be assessed with the care domain of the PCECAT (Person Centred Environment and Care Tool) and the Quality of Interactions Schedule (QUIS)
Timepoint [1] 6482 0
Follow-up will occur at 8 months
Secondary outcome [2] 6483 0
Compare the effect of PCC & PCD+PCC on staff's use of psychotropic medication & physical restraint of dementia
Timepoint [2] 6483 0
Follow-up will occur at 8 months
Secondary outcome [3] 6484 0
Economic analysis will also compare the costs associated with extra services and products required to improve care environments
Timepoint [3] 6484 0
Follow-up will occur at 8 months

Eligibility
Key inclusion criteria
Diagnosed dementia
Minimum age
45 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Residents with a diagnosed dementia with serious co-morbidities which preclude them from engaging in normal daily activities and Social life within the care unit and who are unlikely to be able to participate over the life of teh study (eg. cardiac failure, end-stage illness, unremitting pain/distressing physical symptoms)
Care-sites: State-run aged care homes, aged (High) care homes providing greater than 15% of PCC & PCD as assessed by two validated instruments, the Person-Centred Care Assessment Instrument (PCCAI) and the Person-Centred Care Environment Audit (PCCEA)
Site manager unable to comply with PCD modifications because of government regulations or demands - site will withdrawn from the study.
Care-Staff: Casual and Agency staff.

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)
Site allocation: Study statisticians (MK, GL), who will be blind to the identity of sites, will allocate sites (and thus participants) to intervention groups.

Resident recruitment: Facility managers or directors of nursing will identify eligible residents. A study team member, who will be blind to site allocation, will approach all eligible residents for recruitment. Residents will be provided with a large print information sheet, in the presence of a trusted staff and/or family member, to gain their assent, and where possible, their informed consent.

Staff recruitment: Staff will be recruited through site meetings, where a study team member will explain the study. Staff will also be given a study information sheet.

The study statistician who will generate the allocation sequence will be blind to the identity of the sites. Allocation will be based on clusters rather than individuals, and will be concealed from other study team members until interventions are assigned. Within each site, all residents who meet eligibility criteria will be approached for recruitment by a study team member who is blinded to the site allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Matched randomisation: To help ensure comparability of the intervention and usual care sites with respect to baseline characteristics, sites will matched according to the following criteria:
- Care practice and environmental quality (assessed with the Person Centred Environment and Care Assessment Tool (PCECAT);
- dementia specific unit (yes, no);
- location (inner metropolitan, outer metropolitan, rural);
- size (number of dementia beds – 10-20 beds (small), >20 beds (large);
- type (profit, not for profit)
- organisation (several sites were owned by the same organisation).
Matched groups will be randomly allocated to the four intervention groups. The random allocation sequence will be generated by computerized random-number generator
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3091 0
Government body
Name [1] 3091 0
National Health & Medical Research Council
Country [1] 3091 0
Australia
Primary sponsor type
University
Name
University of Technology Sydney
Address
P.O. Box 222, Eton Road, Lindfield. NSW 2070
Country
Australia
Secondary sponsor category [1] 2782 0
Government body
Name [1] 2782 0
Australian Health Ministers - States & Teritories
Address [1] 2782 0
Canberra, ACT
Country [1] 2782 0
Australia
Other collaborator category [1] 205 0
Other
Name [1] 205 0
Residential Dementia Care Units
Address [1] 205 0
Various throughout Sydney (12 sites), Newcastle (8), Wollongong (8) and Rural NSW (12).
Country [1] 205 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5039 0
UTS Human Research Ethics Committee
Ethics committee address [1] 5039 0
Research & Commercialisation Office University of Technology, Sydney, Level 7, Tower Building, Broadway. NSW 2007
Ethics committee country [1] 5039 0
Australia
Date submitted for ethics approval [1] 5039 0
Approval date [1] 5039 0
21/02/2007
Ethics approval number [1] 5039 0
UTS HREC REF NO. 2006-269A

Summary
Brief summary
The Person-Centred Care (PCC) is consistent with nursing philosophy & is distinguished by care staff making genuine efforts to understand and meet the person's individual needs. PCC improves the person's Quality of Life (QOL) helping them to feel valued for who they are. Person-Centred Environment Design (PCD) - there is a direct link between QOL for person's with dementia & physical space, whereby the physical environment serves as non-pharmacological supportive element in retaining memory, stimulating the remaining senses enabling communication with carers, assisting the person retain self control and reducing levels of anxiety, aggression, depression & psychotic behaviour through built "cues". The physical environment can therefore exercise dramatic psychological impact on QOL for the person with dementia. This randomised controlled trial will evaluate whether PCC and/or PCD improves the QOL and Quality of Care (QOC) of persons with dementia. Another major aspect of the study is to assess the efficiency (Cost Effectiveness) of such measures. The study will be conducted over 3years with 600 person with dementia with 400 care staff in 38 care units in NSW.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28378 0
Address 28378 0
Country 28378 0
Phone 28378 0
Fax 28378 0
Email 28378 0
Contact person for public queries
Name 11535 0
Professor Lynn Chenoweth
Address 11535 0
Health & Ageing Research Unit
War Memorial Hospital
125 Birrel Street
Waverley. NSW 2024
Country 11535 0
Australia
Phone 11535 0
(02) 9369 0288
Fax 11535 0
Email 11535 0
[email protected]
Contact person for scientific queries
Name 2463 0
Professor Lynn Chenoweth
Address 2463 0
Health & Ageing Research Unit
War Memorial Hospital
125 Birrel Street
Waverley. NSW 2024
Country 2463 0
Australia
Phone 2463 0
(02) 9369 0288
Fax 2463 0
Email 2463 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
EmbasePerCEN trial participant perspectives on the implementation and outcomes of person-centered dementia care and environments.2015https://dx.doi.org/10.1017/S1041610215001350
EmbasePerCEN: A cluster randomized controlled trial of person-centered residential care and environment for people with dementia.2014https://dx.doi.org/10.1017/S1041610214000398
EmbaseThe percen study: Supporting client and care outcomes in the residential dementia care setting.2011https://dx.doi.org/10.1016/j.jalz.2011.05.847
EmbaseStudy protocol of a randomised controlled group trial of client and care outcomes in the residential dementia care setting.2011
N.B. These documents automatically identified may not have been verified by the study sponsor.