Randomized controlled trial to reduce falls and fear of falling in frail eldery

Approximately 750.000 Dutch elderly in total, fall at least once a year, which often results in physical injuries and fear of falling, with high costs and far-reaching consequences on functionality, physical activity, quality of life and mental wellbeing. Falling is not only a burden for patients, it also is a burden for the caregivers of frail elders, with frustration, distress and mood disorders as a possible result for both. Dementia or milder cognitive decline, fear of falling, difficulties in performing dual tasks while walking, and disorders in gait and balance are determining the complexity of the problem of recurrent falling in the growing group of frail elderly, because they all result in an increased risk of falling. In this study we aim at developing an intervention to reduce recurrent falling in frail elderly fallers, their fear of falling and the burden for their caregivers, because so far no secondary prevention study proved efficacy in this high risk patients. DESIGN: We designed a randomized controlled, single blinded trial of a multifaceted fall prevention program for this frail group of elders, consisting of physical and cognitive components. Moreover, it includes a trainings program for caregivers to learn to provide supervision and advice the patients. AIMS: -To test,as primary outcomes, the efficacy and determine the costs of a multifaceted intervention program to reduce falls incidence rate and fear of falling, and thereby improve mental wellbeing in community dwelling frail elders, with high level of comorbidity and cognitive decline, who fell at least once in the past 6 months and consulted an outpatient geriatric fall clinic. -To train and support the informal caregivers, which we consider as absolute precondition for an effective intervention in this group, and to improve their feeling of competency in taking care of these patients. -To test whether this intervention reduces fall related injuries and improves physical activity, functional performance measures, reduces fall and biomarkers for vascular health, chronic stress and frailty? SUBJECTS: In principle, patients aged 70 and over and referred to the fall clinic of the UMC St Radboud are eligible for this study if they fell at least once in the last 6 months. PRIMARY OUTCOME MEASURES: The falls incidence rate, fear of falling (FES) and quality of life (MOS-20) of patients are the primary outcome measures. Total observation time of falls will be 6 months after start of the intervention. RANDOMIZATION AND SAMPLE SIZE: Patients will be randomized in groups of 20 (10 controls, 10 participants of the intervention) with minimization for sex, cognition and fall rate at baseline. With an attrition estimated at 15%, we will need to include 160 patients to have 80% power to detect an effect size of 0,5 SD. COST-EFFECTIVENESS: By calculating the costs of the intervention, and taking into account caregiver time and other services needed, we will be able to assess incremental cost-effectiveness ratio’s for the money needed to prevent a patient falling again, to 20% reduce fear of falling, 20% reduce caregiver burden, or to reach combinations of these. QALY’s will be calculated as well by measuring the EQ-6D. ANALYSIS: Intention to treat analysis will be carried out using linear models for the differences in outcome measures between the intervention and control group.