An interdisciplinary intervention to prevent falls in community-dwelling elderly persons: protocol of a cluster-randomized trial [PreFalls]

<p>Abstract</p> <p>Background</p> <p>Prevention of falls in the elderly is a public health target in many countries around the world. While a large number of trials have investigated the effectiveness of fall prevention programs, few focussed on interventions embedded in the general practice setting and its related network. In the Prevent Falls (PreFalls) trial we aim to investigate the effectiveness of a pre-tested multi-modal intervention compared to usual care in this setting.</p> <p>Methods/Design</p> <p>PreFalls is a controlled multicenter prospective study with cluster-randomized allocation of about 40 general practices to an experimental or a control group. We aim to include 382 community dwelling persons aged 65 and older with an increased risk of falling. All participating general practitioners are trained to systematically assess the risk of falls using a set of validated tests. Patients from intervention practices are invited to participate in a 16-weeks exercise program with focus on fall prevention delivered by specifically trained local physiotherapists. Patients from practices allocated to the control group receive usual care. Main outcome measure is the number of falls per individual in the first 12 months (analysis by negative binomial regression). Secondary outcomes include falls in the second year, the proportion of participants falling in the first and the second year, falls associated with injury, risk of falls, fear of falling, physical activity and quality of life.</p> <p>Discussion</p> <p>Reducing falls in the elderly remains a major challenge. We believe that with its strong focus on a both systematic and realistic fall prevention strategy adapted to primary care setting PreFalls will be a valuable addition to the scientific literature in the field.</p> <p>Trial registration</p> <p><a href="http://www.clinicaltrials.gov/ct2/show/NCT01032252">NCT01032252</a></p

24-Months Cluster-Randomized Intervention Trial of a Targeted Fall Prevention Program in a Primary Care Setting

Background!#!Falls and fall-related injuries are common in community-dwelling older persons. Longitudinal data on effective fall prevention programs are rare.!##!Objective!#!Therefore, we evaluated a 4-months multi-component exercise fall prevention program in a primary care setting on long-term effects over 24 months on falls and concomitant injuries in older community-dwelling persons with high risk of falling.!##!Design and setting!#!In the Prevention of Falls (PreFalls) study, forty general practitioners in Germany were cluster-randomized (1:1) into an intervention group (IG) or control group (CG). Three hundred seventy-eight independently living people with high risk of falling (78.1 ± 5.9 years, 75% women) were assigned to IG (n = 222) or CG (n = 156).!##!Intervention and measurements!#!Patients in IG took part in a 4-months multi-component exercise program comprising strength and balance exercises (28 sessions); patients in CG received no intervention. Primary outcome measure was number of falls over 24 months, analyzed by a patient-level, linear mixed Poisson model. Secondary endpoints were number of fall-related injuries, changes in physical function, fear of falling, and mortality.!##!Results!#!After 24 months, the IG demonstrated significantly fewer falls (IRR = 0.63, p = 0.021), injurious falls (IRR = 0.69, p = 0.034), and less fear of falling (p = 0.005). The mortality rate was 5.0% in IG and 10.3% in CG (HR = 0.51, 95% CI: 0.24 to 1.12; p = 0.094).!##!Conclusions!#!In older community-dwelling persons with high risk of falling, a short-term multi-component exercise intervention reduced falls and injurious falls, as well as fear of falling over 24 months

Effects of a complex intervention on fall risk in the general practitioner setting: a cluster randomized controlled trial

Purpose: To study the feasibility of first, reaching functionally declined, but still independent older persons at risk of falls through their general practitioner (GP) and second, to reduce their physiological and psychological fall risk factors with a complex exercise intervention. We investigated the effects of a 16-week exercise intervention on physiological (function, strength, and balance) and psychological (fear of falling) outcomes in community-dwelling older persons in comparison with usual care. In addition, we obtained data on adherence of the participants to the exercise program. Methods: Tests on physical and psychological fall risk were conducted at study inclusion, and after the 16-week intervention period in the GP office setting. The 16-week intervention included progressive and challenging balance, gait, and strength exercise as well as changes to behavioral aspects. To account for the hierarchical structure in the chosen study design, with patients nested in GPs and measurements nested in patients, a three-level linear mixed effects model was determined for analysis. Results: In total, 33 GPs recruited 378 participants (75.4% females). The mean age of the participants was 78.1 years (standard deviation 5.9 years). Patients in the intervention group showed an improvement in the Timed-Up-and-Go-test (TUG) that was 1.5 seconds greater than that showed by the control group, equivalent to a small to moderate effect. For balance, a relative improvement of 0.8 seconds was accomplished, and anxiety about falls was reduced by 3.7 points in the Falls Efficacy Scale–International (FES-I), in the intervention group relative to control group. In total, 76.6% (N = 170) of the intervention group participated in more than 75% the supervised group sessions. Conclusion: The strategy to address older persons at high risk of falling in the GP setting with a complex exercise intervention was successful. In functionally declined, community-dwelling, older persons a complex intervention for reducing fall risks was effective compared with usual care