Frailty Intervention Trial (FIT)

Frailty is a term in common use among health care professionals. It is a term often used to label the condition of an older person who has health problems, has lost functional abilities and is likely to deteriorate further. It is thus a syndrome, describing a health state that could occur as the result of a number of underlying health conditions. As a summary term it has some utility, but little practical clinical or scientific value unless it is adequately defined.

Rockwood and colleagues [1] describe the concept of frailty as a 'multidimensional syndrome of loss of reserves (energy, physical ability, cognition, health) that gives rise to vulnerability'. The clinical conceptualisation of frailty has been described as an observable physical and functional decline in the body associated with physiological changes during later life [2], which is accompanied by social and emotional experiences [3]. Clinical research on frailty has enabled the provision of care to the older population to target those most at risk [4] and in need [5], and to allocate appropriate services and resources [6].

However, frailty does not have a precise definition [7] and is not a specific diagnosis [8]. It is seen as an increasingly common condition in older people but is not an inevitable part of ageing. Many older people are not frail and never become frail, and frailty is also observed in younger people. It is not synonymous with disability as many disabled people are not frail. However, frailty results in disability, and it usually indicates a person at increased risk for morbidity and mortality [9, 10].

There have been a number of attempts to define frailty. It has been described in terms of a syndrome, characterised by decreased reserve and resistance to stressors, resulting from cumulative declines across multiple physiological systems that are close to or past symptomatic clinical failure [11]. Rockwood [12] proposed that the essential feature of frailty is the notion of risk due to instability. Consequently, the frail person is at increased risk of disability and death. Frailty has been described as a "pre-death" syndrome [13], and it has been shown to be the commonest trajectory at the end of life, and to be associated with stroke, Alzheimer's Disease and other dementias, delirium, Parkinson's Disease, hip fracture, incontinence, pneumonia, dehydration, syncope, lower limb cellulitis [14]. Bortz [8] postulated that frailty is the result of early disease in multiple systems resulting in impaired muscle strength, mobility, balance and endurance. He considered that active intervention should be able to reverse much of the state of frailty. The definition of frailty used in the FICSIT (Frailty and Injuries: Cooperative Studies of Intervention Techniques) trials is also focussed on strength, mobility, balance and endurance [15].

Following the Cardiovascular Health Study, Fried et al [16] formulated specific criteria that defined the frailty syndrome. These criteria offer an empirically derived and validated definition for frailty based on the presence of at least three or more defined characteristics. The presence of frailty, as defined by Fried et al, was shown to be independently predictive over a three year period of incident falls, worsening mobility, deteriorating function in activities of daily living, hospitalisation, and death. The Fried frailty characteristics are unexplained weight loss, muscle weakness, self-reported exhaustion, poor endurance (as demonstrated by slow walking speed) and low activity level.

In a United States community dwelling population, aged over 65 years, Fried et al [16] found that 7% of the population met the criteria for frailty. Prevalence of frailty increased with each five-year cohort, and was double in women compared to men. After analysis of data from 2762 older people, Fried et al [16] described three separate aspects of functioning: frailty, disability and co-morbidity. Of people who were frail, 73% concurrently experienced one or both of the other conditions.

Attempts have been made to improve clinical outcomes for frail older people, however no interventions have been developed to specifically reverse the syndrome of frailty. Previous intervention studies targeting frail older people have focussed on using general interventions such as comprehensive geriatric assessment [17‐19] and rehabilitation models [20], with inconclusive effects on functional ability and well-being. A recent systematic review found community-based, multifactorial interventions reduce hospital admission in the frail population, but do not significantly benefit physical function in this group [21]. Specific interventions targeting physical activity have been shown to improve physical function [22, 23], and intervention with nutritional supplements plus exercise has resulted in increased energy intake [23]. Pharmacological interventions [24‐26] produced inconsistent results.

Major limitations of the intervention studies targeting frail older people include the absence of an agreed definition for the term 'frailty'which would allow the precise identification of appropriate patients [2], and the lack of combined intervention studies that evaluate individual needs and customise care to promote the development of function and quality of life in frail older people [21].

Many clients of aged care health services are frail. This study seeks to establish whether a multifactorial, multidisciplinary intervention specifically targeting frailty can be implemented in a general metropolitan hospital aged care service setting, and whether it is effective when compared with usual care.

We are seeking to establish the effect of the intervention on both frailty and mobility. Specifically the hypotheses are that the multifactorial, multidisciplinary intervention will improve performance on a frailty index score and on a mobility index score calculated from the Short Physical Performance Battery score. The secondary outcome measures include days of hospitalisation and residence in nursing care facilities, risk of falling, additional measures of mobility, depression and quality of life. In addition, the study will test whether the Fried definition of frailty can be applied readily in a clinical setting and the ability of an aged care health service to effectively provide the intervention.

If this frailty intervention is shown to be effective, there are major potential benefits to the frail older population generally in terms of decreased disability. Significant cost savings could flow to government and broader society if hospitalisation or institutionalisation can be avoided or postponed. The interventions being examined are readily transferable to routine clinical practice and can potentially be applied routinely in aged care services.

This research is an important step in the examination of an individually-targeted frailty intervention. The study's strengths are the targeting of specific domains in which the individual is frail, the multifactorial intervention which incorporates comprehensive geriatric assessment, and the robust (but pragmatic) clinical trial design.

The study methodology maximises generalisability of the results to the frail population, by facilitating recruitment and retention of frail participants, and avoiding excessive exclusion criteria. Participants are screened for frailty via a validated assessment tool, followed by the identification of the domains of frailty in which they are affected. Unlike many studies in the older population [55], most comorbidities will not cause exclusion unless they are likely to lead to less than twelve months survival. The degree of cognitive impairment deemed incompatible with involvement in this intervention was quantified as a MMSE score of 18 or less. This reflects the non inclusion of cognitive impairment in the Fried frailty criteria and the perceived difficulty of maintaining adequate adherence to the intervention if severe cognitive impairment is present.

This study is unique in that the intervention targets the domains of frailty displayed by the individual. Unlike previous randomised controlled trials, this study has the capacity to deliver a multidimensional intervention, adapted to the needs of each participant, based on comprehensive geriatric assessment. Comprehensive geriatric assessment is a multifaceted, multidisciplinary process, aiming to diagnose individuals' needs and thereby develop effective, integrated and co-ordinated management strategies [56]. Inpatient comprehensive geriatric assessment has been shown to increase the likelihood of being alive in the home at one-year follow-up [56]. This process will be facilitated by the appointment of a case manager, the availability of staff experienced in aged care, goal setting and regular multidisciplinary case conferences.

The effectiveness of exercise in the frail population is documented [22, 23, 57, 58]. The WEBB program was chosen to deliver the exercise as it incorporates the findings of previous studies [50] as well as a recent systematic review of exercise for falls prevention (Sherrington et al., manuscript under review). Adequate intensity of exercise will be ensured by fortnightly physiotherapy home visits in the initial three months. Five visits over the subsequent nine months will enable review of the program, in light of the complex comorbidities in this population. Further, nutritional intervention in undernourished older adults has been found to increase weight and decrease mortality [59]. In frail people, nutritional supplementation has been found to increase total energy intake when used in conjunction with exercise [23].

Multiple steps have been taken to maximise adherence to the intervention. There will be a flexible time-frame for the intervention, goal setting, the involvement of family/carers, treatment in the home environment and the assessment of factors known to contribute to exercise adherence.

Applying the Fried frailty criteria in a clinical setting is not equivalent to the context in which these criteria were developed. An epidemiological study, retrospectively applying the frailty criteria to a cohort of community-dwelling adults 65 years and older, examining the prevalence of frailty and correlating frailty status with factors such as falls and hospitalisation, is clearly different to a clinical trial. It is our impression that some older people have difficulty answering the self report questions that define three of the five Fried criteria (unexplained weight loss, self-reported exhaustion, and low physical activity), and also that cognitive impairment compounds these difficulties. Other studies have since modified the original physical activity criterion [32, 60] because of difficulty using the questions in the initial Fried study. The criterion used by Cesari and colleagues [32] has been adapted to fit the timeframe of this study.

There are some other potential difficulties already identified by this study in the application of the Fried criteria. The criterion of weight loss over one year does not detect significant weight loss over a longer period. With the criterion of self reported exhaustion there are some inconsistencies as some older people state that everything is an effort but they are not prepared to go on to say that they could 'not get going'. Further, some frail people with early Alzheimer's disease or other types of dementia may misinterpret the Fried criteria questions relating to self-reported exhaustion and energy expenditure. The self-report of weight loss may also be less reliable unless there is an informant present. In contrast, the Fried criteria that rely on direct functional assessment of gait speed and grip strength can be completed without difficulty.

This study uses an objective measure of frailty and therefore differs to other methods of assessing frailty that are based on clinician judgement. For example, the Canadian Study of Health and Aging Clinical Frailty Scale [1] may define older people as 'frail' somewhat differently.

If the intervention provides a clinically significant positive effect, the study could establish a new approach to the treatment of older people at risk of further functional decline and institutionalisation. In addition, an evaluation of how well the service can be provided and the participants' acceptance of the intervention will inform the extrapolation of our results to clinical practice. The intervention is readily transferable to routine clinical practice in the setting of aged care health services, and the multidisciplinary approach is relevant to multiple professional groups in aged care. If cost-effectiveness is demonstrated, the multidisciplinary intervention to decrease the rate of decline in frail people will lead to enhanced functional outcomes and more efficient utilisation of health services.