ANZCTR search results

This study will assess the effect and overall survival outcomes of radiotherapy following mastectomy in women with breast cancer. Who is it for? You may be eligible to join this study if you are a female with confirmed unilateral breast cancer with 'intermediate risk' of loco-regional recurrence following mastectomy. Trial details Participants in this trial will be randomly (by chance) allocated to one of two groups. Participants in one group will undergo radiotherapy 5 days a week for 3-5 weeks commencing 12 weeks after mastectomy or 6 weeks after adjuvant chemotherapy. Participants in the other group will receive standard of care and observation only. Participants are followed up twice in the first year, and then annually for 10 years in order to asses the study endpoints.

This National Health and Medical Research Council (NHMRC)funded clinical trial will assess the effect of an exercise-based self-management program for older people who have suffered a lower limb or pelvic fracture in the last two years. The intervention involves a combination of physiotherapy home-visits to establish a home-exercise program and the group-based the Stepping On program. Motivational interviewing and goal setting will be used to encourage behaviour change with regard to exercise and safe community mobility. Three hundred and fifty participants will be recruited from hospitals, health professional practices and general advertising. Primary outcomes are mobility-related disability, community participation and falls. Cost-effectiveness analysis will be undertaken for the primary outcomes.

The study investigated the effectiveness of a high calorie, high protein nutritional supplement in terms of changes in recovery rate as measured by abilities in activities of daily living (ADL), and nutritional status.

The project will evaluate an injury assessment and treatment referral service for those injured in motor vehicle crashes in the ACT. This service will consist of a musculoskeletal specialist, supported by an education program. The primary research hypothesis for the program is that the provision of multidisciplinary musculoskeletal referral service will lead to improved health outcomes for injured people and reduce the duration of illness and associated costs. This will be established through a comparison with a control group of people injured before the service is established.

This is a substudy of the Frailty Intervention Trial - FIT (ACTRN12608000250336). Please refer to ACTRN12608000250336 for a brief summary of the FIT. Informal support is an important part of the total care provided to frail older people and essential to the implementation of patient interventions. However, the examination of informal carers’ experience of a patient intervention is rarely measured. Informal carer experience is an important consideration, particularly in terms of them maintaining their role and quality of care for the frail older person. The aim of this cohort sub study is to compare the effects of a multidisciplinary frailty intervention to usual care of a frail older person living in the community on informal carers’ experience of caregiving. An informal carer is a person who provides unpaid care to a family member or friend who needs help in their daily activities. This ranges from supervision to assistance with personal care, mobility and communication, through to emotional support and practical and financial assistance. Informal carers are key players or partners in the caregiving process and so a concern for their well-being is of importance, particularly in terms of them maintaining their role and quality of care for the frail older patient. As the population ages, the role of the informal carer will become more significant and providing them with appropriate support will be vital. Informal carers of the participants in the Frailty Intervention Trial (FIT)(ACTRN12608000250336) will be invited to participate. A background questionnaire delivered at baseline will determine sociodemographic characteristics, caregiving tasks and care duration. The impact of the Frailty Intervention Trial (FIT) (ACTRN12608000250336) on informal carer’s experience will be measured using three validated carer assessment tools at baseline, 6 months and 12 months. A follow-up measure will also be gathered at 15-18 months. The informal carers will also be given the opportunity to discuss their caregiving experience in a semi-structured interview at 12 months after the baseline questionnaire. The primary objective is to evaluate the impact of The Frailty Intervention (FIT) on informal carers’ positive and negative aspects of caregiving. The secondary objective is to obtain a more sensitive and deeper understanding of the informal carers’ experience via a semi-structured interview. Evaluation of the impact of the Frailty Intervention Trial (FIT)(ACTRN12608000250336) on informal carers’ experience will increase our understanding of aspects of their caregiving by providing insight into carers’ perspectives, highlighting complexities and daily realities of care. In addition, it will provide us with information on how informal carers may be integrated more effectively into the implementation of frailty interventions for older people.

This is a sub-study of the Frailty Intervention Trial (FIT), ACTRN12608000250336. Please refer to ACTRN12608000250336 for a brief summary of the FIT. This sub-study will examine the effect of a goal-focused exercise program on participation in frail, community-dwelling older persons. Participation is defined within the International Classification of Functioning, Disability and Health (ICF) as ‘the individual’s role in a life situation’. The term ‘participation’ evolved from the concept of ‘handicap’, when the ICF reconceptualised disability with the inclusion of the social model. Despite being a key goal of rehabilitation, participation has not been adequately investigated in the frail population. Due to its polyfactorial aetiology, participation can be influenced by intervention, despite the presence of irreversible health conditions and activity limitations in frail people. The interventions proven to modify the remediable clinical, personal and environmental determinants of participation have been combined to form a treatment protocol. The current trial will investigate the effect of an exercise program and goal-focussed barrier modification on participation restriction. Participants recruited for the Frailty Intervention Trial will be invited to take part in the sub-study. In addition to the exercise program provided to the intervention group in the Frailty Intervention Trial, the intervention group will receive two additional physiotherapy sessions. The additional intervention is an individually prescribed program that targets the goals of the individual, with respect to their participation in the home or community environment. The intervention will target potentially remediable barriers to reaching the individual's participation goal eg. walking capacity, social support and community environment. The primary outcome sought is a reduction in the rate of restricted participation. The primary outcome measurements are the Reintegration into Normal Living Index, Goal Attainment Scale and the Life Space Assessment. Secondary outcomes measured are participation, using the question: 'Do you get out of the house as much as you would like?', and the ability to perform activity, measured using the Activity Measure for Post Acute Care and Nottingham Extended Activities of Daily Living Index. A secondary analysis will be conducted to see whether there was an interaction between group allocation and cognition. i.e. Did the effect of the intervention vary according to cognitive status? This sub-study will boost the scant evidence-base for increasing participation in the older person. Combined with outcomes from the Frailty Intervention Trial, this sub-study will provide a more comprehensive understanding of the level of function and disability in the frail population and will enhance understanding of intervention to increase function in the frail population.

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.

The trial will determine the effects of intensive weight-bearing exercise after hip fracture. The outcome variables will be walking speed, quadriceps strength, mobility, balance, activities of daily living and quality of life. The experimental hypothesis is that intensive weight-bearing exercise will produce better mobility, strength, balance and other outcomes with no additional complications (including falls and fall related injuries) than non-weight-bearing exercise at 1 and 4 months after recruitment.