Trial Review

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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
ACTRN12605000667617
Ethics application status
Approved
Date submitted
15/09/2005
Date registered
20/10/2005
Date last updated
3/08/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Promoting Independence in residential care
Scientific title
Falls function and quality of life. Does a functional activity programme make a difference to functional impairment in residents in residential care: a cluster randomised controlled trial
Universal Trial Number (UTN)
Trial acronym
PIRC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Functional impairment in older people in residential care 815 0
Condition category
Condition code
Physical Medicine / Rehabilitation 879 879 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
* A trained research nurse conducts a functional assessment with the assistance of a physiotherapist and occupational therapist when needed
* Participant identifies a functional goal
* Research nurse designs an individualised home-based physical activity programme based on attaining the functional goal. This is written as a prescriptive activity programme
* The health care assistant and resident are taught the programme and work together to encourage resident participation
* The nurse has direct contact with the residents on 2 or 3 occasions and with the caregivers and other staff to provide support over a period of 6 months.
Intervention code [1] 619 0
Rehabilitation
Comparator / control treatment
social visits, 2 visitis over 6 weeks. the visits were conducted by a social researcher who discussed their previous and current social activtiies
Control group
Active

Outcomes
Primary outcome [1] 1134 0
Quality of life and function: change in Late Life FDI
Timepoint [1] 1134 0
12 months from randomisation
Primary outcome [2] 1135 0
Quality of life and function: change in Timed Up and Go
Timepoint [2] 1135 0
12 months from randomisation
Primary outcome [3] 1136 0
Quality of life and function: change in Elderly mobility Scale
Timepoint [3] 1136 0
12 months from randomisation
Secondary outcome [1] 2088 0
Falls, falls self efficacy
Timepoint [1] 2088 0
12 months from randomisation
Secondary outcome [2] 2089 0
Balance, FICSIT 4 point balance test
Timepoint [2] 2089 0
12 months from randomisation
Secondary outcome [3] 2090 0
Adverse events
Timepoint [3] 2090 0
2,4,6,8,12 months from randomisation
Secondary outcome [4] 2091 0
Depressive symptomatology, GDS and Life Satisfaction Index (LSI-Z) over time.
Timepoint [4] 2091 0
12 months from randomisation

Eligibility
Key inclusion criteria
Eligible patients include those living in low level residential care, rest homes, hostels or independent living, able to communicate in English, and not terminally ill or having a major diagnosis of anxiety. Patients with adequate cognition to undertake a conversation about setting a goal were included. This was decided during a review of all potential participants with the clinical nurse managers of residential care homes.
Minimum age
65 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded if they suffer from severe dementia, terminal illness or an unstable cardiac condition, are unable to communicate in English, or are not living in rest homes in Auckland permanently.

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)
An independent investigator in a distant site holds a computer-generated randomisation schedule. After completion of baseline measures of all enrolled residents in participants rest homes the recruitment nurse telephones the independent researcher. The outcome assessor will remain blind to group randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Clustered by resdiential care home
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
19/01/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
685
Accrual to date
Final
Recruitment outside Australia
Country [1] 227 0
New Zealand
State/province [1] 227 0

Funding & Sponsors
Funding source category [1] 969 0
Government body
Name [1] 969 0
Health Research Council of NZ
Country [1] 969 0
New Zealand
Primary sponsor type
Government body
Name
Health Research Council of NZ
Address
Grafton Rd, Grafton Auckland 1001
Country
New Zealand
Secondary sponsor category [1] 837 0
University
Name [1] 837 0
University of Auckland
Address [1] 837 0
rivate BAg 92019, Auckland
Country [1] 837 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2274 0
Northern X Ethics Committee
Ethics committee address [1] 2274 0
Auckland
Ethics committee country [1] 2274 0
New Zealand
Date submitted for ethics approval [1] 2274 0
Approval date [1] 2274 0
Ethics approval number [1] 2274 0

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

Contacts
Principal investigator
Name 35876 0
Address 35876 0
Country 35876 0
Phone 35876 0
Fax 35876 0
Email 35876 0
Contact person for public queries
Name 9808 0
Kathy Peri
Address 9808 0
Department of General Practice and Primary Health Care
School of Population Health
University of Auckland
Glen Innes 1065
Country 9808 0
New Zealand
Phone 9808 0
+64 9 3737999
Fax 9808 0
Email 9808 0
k.peri@auckland.ac.nz
Contact person for scientific queries
Name 736 0
Ngaire Kerse
Address 736 0
Department of General Practice and Primary Health Care
School of Population Health
University of Auckland
Glen Innes 1065
Country 736 0
New Zealand
Phone 736 0
+64 9 3737599 ext. 84467
Fax 736 0
+64 9 3737624
Email 736 0
n.kerse@auckland.ac.nz

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 AIDoes a functional activity programme improve function, quality of life, and falls for residents in long term care? Cluster randomised controlled trial2008https://doi.org/10.1136/bmj.a1445
Dimensions AIHome-Based Activity Program for Older People With Depressive Symptoms: DeLLITE–A Randomized Controlled Trial2010https://doi.org/10.1370/afm.1093
N.B. These documents automatically identified may not have been verified by the study sponsor.