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Trial registered on ANZCTR


Registration number
ACTRN12608000250336
Ethics application status
Approved
Date submitted
13/05/2008
Date registered
16/05/2008
Date last updated
2/05/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Frailty Intervention Trial
Scientific title
The effect of a multifactorial, multidisciplinary frailty intervention involving nursing, medical, physiotherapy, occupational therapy, dietetic and psychology input on the rate of functional decline in frail older people compared with usual care i.e. the combination of aged care and health services that is routinely provided.
Secondary ID [1] 280428 0
None
Universal Trial Number (UTN)
Trial acronym
FIT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Frailty 3135 0
Premature admission to residential care 3136 0
Disability 3137 0
Undernutrition 3138 0
Falls 3139 0
Psychological morbidity 3140 0
Chronic health conditions associated with ageing 3141 0
Condition category
Condition code
Physical Medicine / Rehabilitation 3299 3299 0 0
Other physical medicine / rehabilitation
Public Health 3300 3300 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Multifactorial, multidisciplinary frailty intervention involving nursing, medical, physiotherapy, occupational therapy, dietetic and psychology inputs such as
exercise and supply of appropriate aids to address functional limitations,
nutritional assessment and supplementation to address nutritional status if necessary, a validated screening instrument and assessment of cause to address falls risk, neuropsychological assessment to address psychological state, cognitive behavioural therapy as necessary, management of chronic health conditions. Assessments may involve video taping.
Intervention code [1] 2877 0
Rehabilitation
Intervention code [2] 2878 0
Treatment: Other
Comparator / control treatment
Usual care - combination of aged care and health services that are routinely provided.
Control group
Active

Outcomes
Primary outcome [1] 4186 0
Time required to complete the Timed Up and Go test
Timepoint [1] 4186 0
At baseline, three and 12 months after randomisation
Primary outcome [2] 4187 0
Short Physical Performance Battery Score
Timepoint [2] 4187 0
At baseline, three and 12 months after randomisation
Secondary outcome [1] 7074 0
Frailty assessment score
Timepoint [1] 7074 0
At baseline, three and 12 months after randomisation
Secondary outcome [2] 7075 0
Unplanned hospitalisation or admission to residential care facility
Timepoint [2] 7075 0
At baseline, three and 12 months after randomisation
Secondary outcome [3] 7076 0
Activities of daily living status (using Barthel Index)
Timepoint [3] 7076 0
At baseline, three and 12 months after randomisation
Secondary outcome [4] 7077 0
Health related quality of life (using the EQ-5D)
Timepoint [4] 7077 0
At baseline, three and 12 months after randomisation
Secondary outcome [5] 7078 0
Psychological status (using the Geriatric Depression Scale)
Timepoint [5] 7078 0
At baseline, three and 12 months after randomisation
Secondary outcome [6] 7079 0
Satisfaction with service provision via a questionnaire to all participants
Timepoint [6] 7079 0
At baseline, three and 12 months after randomisation
Secondary outcome [7] 7080 0
Incremental cost effectiveness via comparisons of the resource utilisation of the intervention and control groups
Timepoint [7] 7080 0
At baseline, three and 12 months after randomisation

Eligibility
Key inclusion criteria
Aged >=70 years, with 3 or more Fried Frailty Criteria, not usually living in a residential aged care facility, resident in the Hornsby Ku-ring-gai local government areas, without severe cognitive impairment (defined as a MMSE score of 18 or less), absence of illnesses likely to be associated with a life expectancy of less than 12 months.
Minimum age
70 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People who did not meet all of the inclusion criteria or who did not consent.

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)
The study nurse screens for inclusion criteria. If the person satisfies criteria the study nurse then telephones the research program manager for treatment allocation (until this point the study nurse is blinded to the treatment allocation).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation is used to achieve balanced treatment allocation. There are two strata (frail with 3 frailty criteria and very frail with 4 or 5 frailty criteria). A random number sequence was generated for the order of treatment allocation within the blocks using SPSS v15 RV.UNIFORM function. Varying block sizes were used. The blocks were randomly arranged within larger sized blocks.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

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

Funding & Sponsors
Funding source category [1] 3376 0
Government body
Name [1] 3376 0
National Health and Medical Research Council
Address [1] 3376 0
GPO Box 1421
Canberra ACT 2601
Country [1] 3376 0
Australia
Primary sponsor type
Individual
Name
Professor Ian Cameron
Address
Royal Rehabilitation Centre Sydney
Rehabilitation Studies Unit
PO Box 6
Ryde NSW 1680
Country
Australia
Secondary sponsor category [1] 3020 0
Individual
Name [1] 3020 0
A/Professor Susan Kurrle
Address [1] 3020 0
Hornsby Ku-ring-gai Health Service Division of Rehabilitation and Aged Care
Palmerston Road
Hornsby, NSW 2077
Country [1] 3020 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5402 0
Harbour HREC Northern Sydney Central Coast Health
Ethics committee address [1] 5402 0
The Research Office
Level 4, Vindin House
Royal North Shore Hospital
St Leonards NSW 2065
Ethics committee country [1] 5402 0
Australia
Date submitted for ethics approval [1] 5402 0
Approval date [1] 5402 0
01/11/2007
Ethics approval number [1] 5402 0
0709-191M

Summary
Brief summary
Frailty is a term in common use amongst health care professionals and in the general community. It has often been used to describe the condition of an older person who has chronic health problems, has lost functional abilities and is likely to deteriorate further. However despite its common use, only a small number of studies have attempted to define the syndrome of frailty and measure its prevalence. Attempts been made to improve clinical outcomes for frail older people using general interventions such as comprehensive geriatric assessment, and specific interventions such as exercise programs or nutritional supplementation, but no interventions have been developed to specifically reverse the syndrome of frailty.

A definition of frailty has been formulated allowing more precise identification of frail older people and this has been used in a number of subsequent studies. This empirically derived and validated definition for frailty is based on the presence of at least three or more defined characteristics (the “Fried frailty criteria”). These characteristics are shrinking (unintentional weight loss of more than 4.5 kg or greater than 5% of body weight in the previous year), weakness (grip strength in the lowest quintile adjusted for age and gender), self-reported exhaustion, poor endurance (in lowest quintile for walking speed adjusted for age and gender), and low activity (weekly energy expenditure of less than 380kcal/1600kJ in men and 270kcal/1130kJ in women). The presence of frailty as defined was independently predictive, over a three year period, of incident falls, worsening mobility, deteriorating function in activities of daily living, hospitalisation, and death. The low activity criterion is relatively complex to measure and alternatives have been described.

This project aims to identify older people who are seen by the aged care service of a metropolitan hospital and who are frail and therefore at risk of hospitalisation and admission to residential aged care facilities, falls, and deteriorating mobility and function. These older people may be seen in the Emergency Department, as inpatients in the hospital wards, in the outpatient clinics, or in the community by the Aged Care Assessment Team. They will be offered the opportunity to participate in this project, when treatment from the hospital Rehabilitation and Aged Care service has been completed. Those who consent to participate will be assessed for frailty according to the Fried frailty criteria. Those who meet the definition of frailty will be randomised to receive either usual care or the multifactorial, multidisciplinary frailty intervention. The intervention will involve nursing, medical, physiotherapy, occupational therapy, dietetic and psychology input. In this intervention, functional limitations will be addressed through the use of exercise and supply of appropriate aids, nutritional status through the use of nutritional assessment and supplementation if necessary, falls risk through the use of a validated screening instrument and assessment of cause, psychological state through the use of neuropsychological assessment and cognitive behavioural therapy as necessary, and appropriate management of chronic health conditions will be facilitated.

The primary outcome sought is a reduction in the rate of functional decline. The primary outcome measurements are the time required to complete the “Timed Up and Go” test, and the Short Physical Performance Battery, at three and 12 months after randomisation. Secondary outcomes, also measured at 3 and 12 months, are frailty assessment score, unplanned hospitalisation or admission to residential care facility, activities of daily living status (using Barthel Index), health related quality of life (using the EQ-5D), psychological status (using the GDS), satisfaction with service provision and incremental cost effectiveness.

This project will confirm whether the Fried frailty criteria are able to be used in an aged care service setting, whether an intervention specifically targeting frailty can be implemented, and whether it is effective when compared to usual care. If this intervention is shown to be effective, there are major potential benefits to the frail older population in terms of decreased disability and improved quality of life, and significant cost savings for government if hospitalisation or institutionalisation can be postponed or avoided. The interventions being examined are readily transferable to routine clinical practice and can be applied in aged care services throughout Australia.
Trial website
http://www.rehab.med.usyd.edu.au/tie/fit
Trial related presentations / publications
Monaghan N. Cameron I. Kurrle S. Lord S. Sherrington C. Crotty M. Gray L. Improving Health Outcomes for Frail Older People. Oral Presentation 3rd International Clinical Trials Symposium Sydney 2007.
Public notes

Contacts
Principal investigator
Name 28583 0
Address 28583 0
Country 28583 0
Phone 28583 0
Fax 28583 0
Email 28583 0
Contact person for public queries
Name 11740 0
Noeline Monaghan
Address 11740 0
Rehabilitation Studies Unit
University of Sydney
PO Box 6
RYDE NSW 1680
Country 11740 0
Australia
Phone 11740 0
+61 2 9808 9236
Fax 11740 0
+61 2 9809 9037
Email 11740 0
nmonaghan@usyd.edu.au
Contact person for scientific queries
Name 2668 0
Professor Ian Cameron
Address 2668 0
Rehabilitation Studies Unit
University of Sydney
PO Box 6
RYDE NSW 1680
Country 2668 0
Australia
Phone 2668 0
+61 2 9808 9236
Fax 2668 0
+61 2 9809 9037
Email 2668 0
ianc@mail.usyd.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary