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Frailty Intervention Trial

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.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12608000250336
Acronym
FIT
Enrollment
330
Registered
2008-05-16
Start date
2008-01-25
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 nece

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.

Sponsors

Professor Ian Cameron
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
70 Years to No maximum
Healthy volunteers
No

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.

Exclusion criteria

People who did not meet all of the inclusion criteria or who did not consent.

Outcome results

None listed

Source: ANZCTR · Data processed: Apr 4, 2026