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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]

None

Universal Trial Number (UTN)

Trial acronym

FIT

Linked study record

Health condition

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

Disability

Frailty

Chronic health conditions associated with ageing

Falls

Psychological morbidity

Premature admission to residential care

Undernutrition

Condition category

Condition code

Public Health

Health service research

Physical Medicine / Rehabilitation

Other physical medicine / rehabilitation

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]

Rehabilitation

Intervention code [2]

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]

Time required to complete the Timed Up and Go test

Timepoint [1]

At baseline, three and 12 months after randomisation

Primary outcome [2]

Short Physical Performance Battery Score

Timepoint [2]

At baseline, three and 12 months after randomisation

Secondary outcome [1]

Activities of daily living status (using Barthel Index)

Timepoint [1]

At baseline, three and 12 months after randomisation

Secondary outcome [2]

Frailty assessment score

Timepoint [2]

At baseline, three and 12 months after randomisation

Secondary outcome [3]

Incremental cost effectiveness via comparisons of the resource utilisation of the intervention and control groups

Timepoint [3]

At baseline, three and 12 months after randomisation

Secondary outcome [4]

Health related quality of life (using the EQ-5D)

Timepoint [4]

At baseline, three and 12 months after randomisation

Secondary outcome [5]

Psychological status (using the Geriatric Depression Scale)

Timepoint [5]

At baseline, three and 12 months after randomisation

Secondary outcome [6]

Unplanned hospitalisation or admission to residential care facility

Timepoint [6]

At baseline, three and 12 months after randomisation

Secondary outcome [7]

Satisfaction with service provision via a questionnaire to all participants

Timepoint [7]

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

Sex

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

25/01/2008

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

330

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

GPO Box 1421
Canberra ACT 2601

Country [1]

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]

Individual

Name [1]

A/Professor Susan Kurrle

Address [1]

Hornsby Ku-ring-gai Health Service Division of Rehabilitation and Aged Care
Palmerston Road
Hornsby, NSW 2077

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Harbour HREC Northern Sydney Central Coast Health

Ethics committee address [1]

The Research Office
Level 4, Vindin House
Royal North Shore Hospital
St Leonards NSW 2065

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

01/11/2007

Ethics approval number [1]

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

Address

Country

Phone

Fax

Email

Contact person for public queries

Name

Noeline Monaghan

Address

Rehabilitation Studies Unit
University of Sydney
PO Box 6
RYDE NSW 1680

Country

Australia

Phone

+61 2 9808 9236

Fax

+61 2 9809 9037

Email

nmonaghan@usyd.edu.au

Contact person for scientific queries

Name

Professor Ian Cameron

Address

Rehabilitation Studies Unit
University of Sydney
PO Box 6
RYDE NSW 1680

Country

Australia

Phone

+61 2 9808 9236

Fax

+61 2 9809 9037

Email

ianc@mail.usyd.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
Embase	A multifactorial interdisciplinary intervention reduces frailty in older people: Randomized trial.	2013	https://dx.doi.org/10.1186/1741-7015-11-65
Embase	Effect of a multifactorial, interdisciplinary intervention on risk factors for falls and fall rate in frail older people: a randomised controlled trial.	2014	https://dx.doi.org/10.1093/ageing/aft204
Embase	Economic evaluation of the e-Health StandingTall balance exercise programme for fall prevention in people aged 70 years and over.	2022	https://dx.doi.org/10.1093/ageing/afac130

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