Leptin is better than any other biological parameter for monitoring the efficacy of renutrition in hospitalized malnourished elderly patients.

OBJECTIVE: Despite malnutrition being a major problem in hospitalized elderly patients, there is a lack of studies focusing on the comparative value of biological parameters for monitoring renutrition. The aim of this study was to determine which biological parameter(s) could best monitor successful renutrition in hospitalized malnourished elderly patients. DESIGN: The objective of the study was to explore the impact of a 6-week renutrition process on anthropometric and biological parameters in elderly patients and to define the biological parameters associated with weight regain. PATIENTS: A total of 72 hospitalized malnourished elderly patients admitted to a hospital-based geriatric rehabilitation unit. MEASUREMENTS: Patients were evaluated at admission and at 6 weeks for anthropometric measurements of weight, sum of the four subcutaneous skinfold thicknesses, calf circumference and biological serum parameters including albumin, transthyretin, leptin, IGF-1, IGFBP-1 and IGFBP-3. Renutrition was considered successful if a patient gained at least 5% of body weight over 6 weeks. RESULTS: Leptin was the only biological parameter that increased at 6 weeks in successful renutrition. Leptin variations were not influenced by C-reactive protein variations, in contrast to transthyretin which can be modified by the inflammatory states frequently encountered in geriatric patients. CONCLUSIONS: Serum leptin is a more appropriate parameter than transthyretin for monitoring renutrition.

[Management of pneumonia in the elderly]. / Prise en charge d'une pneumonie du sujet agé.

Pneumonias in elderly are frequent and severe. They require an accurate assessment following clinical, biological and radiological steps. Each of them can contribute to give answers to the following questions: does this patient need emergency hospitalisation? Is the infection really bacterial and pulmonary? Should antibiotics be started? Which others treatments should be associated for the infection itself and for comorbid conditions? Concerning prevention, every effort must be done to decrease the incidence of these infections, especially vaccination. Pulmonary infections in nursing home need specific attention: cumulation of bad prognosis factors, risk of epidemic propagation, and vaccination of all people caring patients when required.

Exercise Interventions With Trained Home Helpers for Preventing Loss of Autonomy and Falls in Community-Dwelling Older Adults Receiving Home Heath Physical Therapy T4H: A Randomized Controlled Pilot Study.

BACKGROUND AND PURPOSE: Older adults at risk for falls live independently in the community in their own home and have rehabilitation needs. However, little is known about whether home coaching of older adults can decrease falls at home. We sought to determine whether a novel program for preventing falls and a loss of exercise capacity, the T4H program, in which home helpers act as exercise coaches by using an information technology (IT) device, was acceptable and feasible. METHODS: Between February 2015 and October 2015, we performed a cluster randomized controlled trial in which home helpers either assisted older adults 75 years and over, to participate in the T4H program, or provided standard home help over 3 months. We assessed levels of acceptability and satisfaction among the older adults and home helpers with regard to the exercise program and the technologies used. To measure efficacy, the main outcome measures for the older adults were the absence of falls requiring medical or paramedical care, unplanned hospitalizations, walking ability in a Timed Up and Go test (TUG), and self-care ability by the Barthel Index at the 3-month follow-up visit. RESULTS AND DISCUSSION: Overall, 35 older adults were included, aged 89 years and with 68.6% women. Eighty-five percent of the respondents were pleased or very pleased to have participated in the T4H exercise program, 70% were satisfied with the IT devices, and 92% were satisfied with their home helper's level of involvement. Two of the 4 home helper respondents were satisfied or very satisfied with the exercise program, and 2 were moderately satisfied. The proportions of older adult participants with no falls or no unplanned hospitalizations were higher in the T4H group (92.3% and 85.7%, respectively) than in the control group (81.8% and 71.4%, respectively), although these intergroup differences were not statistically significant. The T4H and control groups did not differ significantly with regard to the TUG time (median [IQR]: 27.6 seconds [17.9-58.6] vs 30.7 seconds [19.7-57.2], respectively) or the Barthel Index (median [IQR]: 90 [75-95] and 90 [75-95], respectively). CONCLUSIONS: The novel T4H home help model was feasible and was associated with a high level of participant satisfaction. We observed a trend toward fewer falls and hospitalizations and better quality of life in the older adults.

Motor score of the Unified Parkinson Disease Rating Scale as a good predictor of Lewy body-associated neuronal loss in the substantia nigra.

BACKGROUND: How well the motor symptoms assessed by the motor section of the Unified Parkinson Disease Rating Scale (UPDRS3) reflect the neuronal loss observed in the substantia nigra is not known. OBJECTIVE: To study the relationships among the motor symptoms assessed by the UPDRS3, Lewy body-associated neuronal loss in the substantia nigra, and duration of disease. DESIGN: Longitudinal, prospective, clinicopathological study. SETTING: Long-term care facility of a university hospital. PATIENTS: Eighteen elderly patients with a parkinsonian syndrome, studied prospectively but selected post mortem on the basis of the presence of Lewy bodies, and 5 age-matched control subjects. METHODS: One map of a section of the substantia nigra, indicating the location of all the nucleolated neuronal profiles, was drawn for each case. Neuronal density was estimated using a tessellation method. The relationship between time and neuronal loss and between neuronal loss and motor symptoms (assessed by the UPDRS3) was studied by means of regression analysis, using linear and exponential models. RESULTS: The neuronal density was linearly linked with the UPDRS3 score (r = -0.83 [P<.001]). Each point added to the UPDRS3 score corresponded to an estimated loss of 25 neurons/mm(3). The density of neuronal profiles in the substantia nigra decreased exponentially with time (r = -0.73 [P<.001]). Extrapolation of the curve suggested a presymptomatic phase of 5 years. CONCLUSION: The UPDRS3 score is linearly linked to neuronal density, which, in Lewy body diseases, decreases exponentially with time at a similar pace in this series of elderly patients and in the younger patients described in the literature.

[Medication and memory: interactions among the elderly]. / Médicaments et mémoire: des interactions à connaître chez le sujet âgé.

Several different systems govern human memory, and different drugs may act specifically on one or more of them. The central nervous system in the elderly is particularly sensitive to drugs, and an iatrogenic cause must be sought for all recent and/or sudden alterations in memory functions. In the case of recent alterations in memory, all nonessential drugs, especially psychotropic agents; should be withdrawn or reduced. Elderly persons, especially those with dementia, are at risk because of the frequent and substantial effects of drugs on their memory: the benefit-risk ratio must be evaluated regularly and essential treatments maintained.

Randomized controlled drug trials on very elderly subjects: descriptive and methodological analysis of trials published between 1990 and 2002 and comparison with trials on adults.

BACKGROUND: Very elderly subjects (VES; aged 80 years or older) constitute a special population as they frequently present multiple diseases (polypathology). Results from trials on general adult populations therefore cannot be extrapolated to VES. We performed a census of randomized controlled trials (RCT) on VES published between 1990 and 2002, and carried out a descriptive and methodological analysis of these RCT/VES, comparing them with matched RCT on general adult populations (control RCT, RCT/C). METHODS: We searched for RCT/VES in two international databases (EMBASE and MEDLINE) and then manually. RCT/C were matched to RCT/VES for disease area and year of publication. The methodological quality of each RCT was assessed with Chalmers' scale. RESULTS: We identified 84 RCT/VES, 63 of which were conclusive and 21, inconclusive. Subjects were institutionalized in 48 RCT, and community dwelling in 11 RCT (unspecified in 25 RCT). Efficacy was the main criterion in 75 RCT; tolerance in 9 RCT. Twenty-six RCT were published by geriatrics journals, and 58 by general medical journals. The RCT/VES covered most of the disease areas of geriatrics. The 84 RCT/VES had a mean methodological quality score of 0.578 +/- 0.157. The matched 84 RCT/C had a mean methodological quality score of 0.592 +/- 0.116 (p = .466). The methodological quality score of RCT/VES increased with the number of included subjects (p = .004) and the year of publication (p = .001). CONCLUSIONS: The methodological quality of RCT/VES is equivalent to that of RCT in general adult populations. Nevertheless, RCT/VES remain very scarce, and neglect certain diseases. RCT/VES and the inclusion of very elderly subjects in RCT on adults should be strongly encouraged.

[Clinical trials in very elderly people: the point of view of geriatricians]. / Les essais thérapeutiques chez les sujets très agés: le point de vue des gériatres.

BACKGROUND: Very elderly subjects (aged > or =80 years) and polypathological elderly subjects experience frequent and serious adverse drug effects. They are nevertheless still excluded from clinical research. METHODS: We questioned geriatricians through a questionnaire about the usefulness and feasibility of randomised controlled trials (RCTs) in this population. RESULTS: Forty-eight percent of geriatricians questioned did participate in RCTs, but 96.8% considered that RCTs including very elderly subjects were scientifically necessary. Among geriatricians who never participated in RCTs, 36% were never contacted regarding participation in such clinical research. The most important difficulties in developing RCTs in very elderly subjects were methodological difficulties (narrow eligibility criteria incompatible with patient heterogeneity) and those associated with patient consent. For 38.2% of the geriatricians, the fact that pharmaceutical companies are under no obligation to promote RCTs in very elderly subjects represents a major obstacle in the development of such RCTs. CONCLUSIONS: The development of RCTs involving very elderly subjects depends first on a political choice, together with an adapted regulatory framework.

[Needs, uses, cons-pros, good practices and opportunities about walker in elderly with loss of autonomy]. / Besoins, usages, bénéfices-inconvénients, bonnes pratiques et perspectives en matière de déambulateurs chez les sujets âgés dépendants.

Non-use of the walker may be secondary to an initial inappropriate prescribing, a lack of adequate training, a lack of monitoring and side effects of using. Improving both stability and mobility in users is due to several biomechanical mechanisms. The benefits of walker are: general physiological effects, more confidence, better social life and decrease in the burden of care. The disadvantages of walker are: technical or practical aspects criticized by users, musculoskeletal disorders, delayed reaction time, fall risk and stigma. Few scientific data evaluating the interest of the walker concerning mobility exist, thus recommendations are low grade and are often taken from professional clinical experiences. The choice of technical walking assistance depends on the pathology and biomechanical mechanism. The walker robots are few distributed.

Fall related to epileptic seizures in the elderly.

It is well known that both falls and epileptic seizures are very frequent and harmful in the elderly. Moreover, although seizures may cause falls, their relationship is poorly documented in this population. We report four women (mean age: 84.5 years) who presented falls with: late-onset focal seizures of possible parietal (Case 1) or frontal localisation (Case 2), early onset with late aggravation of juvenile myoclonic epilepsy (Case 3), and generalised situation-related myoclonic seizures (Case 4). Falls were presumably associated with tonic posturing of left (Case 1) or right (Case 2) hemibody, to bilateral and massive myoclonic jerks (Cases 3 and 4) with a loss of consciousness (Case 3). The diagnosis of seizures was difficult and routine EEG was unremarkable in Cases 1 and 2, requiring video-EEG monitoring to capture the clinical events. Adequate treatment offered recovery from seizures and falls in all patients. Other mechanisms of seizure-induced falls in older patients and their management are discussed. In conclusion, falls may be caused by different seizure types and appear to be underestimated due to difficulties in seizure diagnosis in the elderly. Recognizing falls related to seizures is important in geriatric practice, as it facilitates adequate management.

Leukocyte Telomere Length in Alzheimer's Disease Patients with a Different Rate of Progression.

BACKGROUND: Age and short leukocyte telomeres have been associated with a higher risk of Alzheimer's disease (AD). Inflammation is involved in AD and it is suggested that anti-inflammatory interleukin-10 (IL-10) may partly antagonize these processes. OBJECTIVE: The aim is to correlate telomere length (TL) in peripheral blood mononuclear cells (PBMC) from patients with AD to disease progression rate. Moreover, we evaluated whether TL was associated with IL-10 production by unstimulated or amyloid-ß (Aß)-stimulated PBMC. METHODS: We enrolled 31 late-onset AD and 20 age-matched healthy elderly (HE). After a two-year follow-up period, patients were retrospectively evaluated as slow-progressing (ADS) (Mini Mental State Examination (MMSE) decline over the two years of follow-up ≤3 points) or fast progressing AD (ADF) (MMSE decline ≥5 points). TL was measured by flow cytometry and in vitro IL-10 production by enzyme-linked immunosorbent assay. RESULTS: TL (mean±SD) for HE, ADS, and ADF was 2.3±0.1, 2.0±0.1, and 2.5±0.1 Kb, respectively. ADS showed a shorter TL compared to HE (p = 0.034) and to ADF (p = 0.005). MMSE decline correlated with TL in AD (R2 = 0.284; p = 0.008). We found a significant difference in IL-10 production between unstimulated and Aß-stimulated PBMC from ADS (40.7±13.7 versus 59.0±27.0; p = 0.004) but not from ADF (39.7±14.4 versus 42.2±22.4). HE showed a trend toward significance (47.1±25.4 versus 55.3±27.9; p = 0.10). CONCLUSION: PBMC from ADF may be characterized by an impaired response induced by Aß and by a reduced proliferative response responsible for the longer telomeres. TL might be a contributing factor in predicting the rate of AD progression.

Interleukin-10 Production in Response to Amyloid-ß Differs between Slow and Fast Decliners in Patients with Alzheimer's Disease.

We investigated IL-10 and IL-6 production in amyloid-ß (Aß) stimulated peripheral blood mononuclear cells (PBMCs) in twenty Alzheimer's disease (AD) patients with slow progression, eleven with fast progression, and twenty age-matched controls. Promoter polymorphisms in IL-10 (position -592, -819, -1082), IL-6 (-174), transforming growth factor-ß1 (TGF-ß1) (-10, -25), interferon-γ (IFN-γ) (-874), and tumor necrosis factor-α (TNF-α) (-308) genes were analyzed. IL-10 production after Aß stimulation was high in PBMCs from slow decliners and almost completely abrogated in fast decliners. Association between AA IFN-γ low-producing genotype and fast progression was demonstrated. Investigations in a larger sample will clarify these findings.

Evaluation of a new hands-up ergonomics for chest radiography in geriatric patients.

RATIONALE AND OBJECTIVES: Pneumonia is the leading cause of death after the age of 85 years. Chest radiography (CXR) requires forced inspiration for accurate assessment, but kyphosis, denutrition, muscular weakness, and neurologic disorders limit active inspiration. The aim of this study was to evaluate a new passive expansion technique, by raising the patient's arms above the head, in the radiographic diagnosis of pneumonia. METHODS: During a 10-month period, CXR were performed in 1452 geriatric patients for pulmonary acute disorders in our geriatric university hospital. When fewer than five anterior rib segments were visible on the conventional front view, a second CXR was performed with the patient's arms being raised above the head by a radiologist. The diagnostic questions were: Are more than five anterior rib segments present? Is pneumonia visible? The chest radiographs were independently analyzed (3-step confidence scale) by two radiologists and compared by interobserver kappa-coefficients calculation. RESULTS: One hundred three patients (97 female, 6 male), representing 7% of the examined population, with an average age of 86.5 years (range, 70-104 years) were included. An additional anterior rib segment was visible on the front CXR when the arms were raised above the head (P < 0.001). Pneumonia was diagnosed in 59 patients with high agreement (kappa = 0.84) by the passive expansion technique, whereas the pneumonia infiltrate was visible in only 44 patients with considerably lower agreement (kappa = 0.36) when the arms were positioned along the trunk (P < 0.03). CONCLUSIONS: Raising the arms above the head optimizes the quality of CXR and increases the detection of pneumonia in the geriatric patient. New ergonomics and adequate contention are required.

Risk factors for deep vein thrombosis in inpatients aged 65 and older: a case-control multicenter study.

OBJECTIVES: To identify independent risk factors of symptomatic deep vein thrombosis (DVT) in geriatric inpatients and to define high-risk patients likely to benefit from preventive treatment. DESIGN: Hospital-based case-control multicenter study with prospective data collection. SETTINGS: Geriatric university hospitals with long-, intermediate-, and short-term care facilities. PARTICIPANTS: All patients aged 65 and older in 19 geriatric departments were submitted to clinical surveillance over a 16-month period. MEASUREMENTS: Twenty-three potential risk factors of phlebitis were screened for. Comparison using logistic regression of 310 consecutive patients with symptomatic DVT versus 310 randomly selected controls was performed. The risk for symptomatic DVT in geriatrics was then scored from the clinical risk factors identified using multivariate analysis. This score is defined by the sum of the odds ratio (OR) of each risk factor present. RESULTS: Six factors were identified as independently related to the development of DVT: restriction of mobility (from OR=1.73, limited mobility without immobilization, to OR=5.64, bedridden during <15 days), aged 75 and older (OR=1.5/10 years), history of DVT or pulmonary embolism (OR=3.38), acute heart failure (OR=2.52), chronic edema of the lower limbs (OR=2.51), and paresis or paralysis of a lower limb (OR=2.06). The defined score of 8 or higher corresponded to an 88.7% probability of having symptomatic DVT. CONCLUSION: Treatments to prevent symptomatic DVT in hospitalized elderly should be evaluated on patients with these factors.

[Percutaneous endoscopic gastrostomy in elderly patients. A prospective study in a geriatric hospital]. / Résultats de la gastrostomie percutanée endoscopique chez le sujet âgé

OBJECTIVES: The purpose of this work was to search for prognostic factors after percutaneous endoscopic gastrostomy (PEG) for enteral nutrition in geriatric patients by studying complications, nutritional benefits, and impact on quality of life. METHODS: In this prospective study, 59 elderly patients referred for PEG were followed for 1 year or until tube removal or death. Complications, tolerance to enteral nutrition, nutritional status, infection, bedsores and quality of life were assessed by a questionnaire at tube insertion, at 1 month and every 3 months. Multivariate analysis was performed to look for factors predictive of early mortality before one month. RESULTS: Insertion of the PEG tube was always successful. Pneumonia in the week before tube insertion was predictive of early mortality (odds-ratio: 8.77 [1.63-47.2], P=0.01). Thirty-day mortality was 25%, but was never related to PEG tube insertion. During follow up, no local complication was observed and enteral feeding was well tolerated. After 3 months, serum albumin and prealbumin levels increased (P<0.001). There were fewer infections (P<0.001) and bedsores remained unchanged. Quality-of-life scores were not modified. At one year, the PEG tube was removed in 16 patients who resumed normal oral nutrition, and 6 other patients were able to return to their home. CONCLUSION: In a cohort of aged institutionalized patients, PEG for enteral nutrition was well tolerated and not definitive in more than one-quarter of them. Active lung infection is a risk factor of early mortality.

Effects of malnutrition on cytochrome P450 1A2 activity in elderly patients.

Little is known of the influence of nutritional status on cytochrome P450 (CYP) 1A2 activity in elderly patients. Thirty elderly institutionalised patients with malnutrition (group A, aged 88 +/- 5 years) and 24 without (group B, aged 81 +/- 9 years) were included. Malnutrition was defined as weight loss of >10% over the previous 6 months and/or a body mass index (BMI) <21 kg/m2 and albuminaemia < or = 32 g/L. CYP1A2 activity was evaluated by the plasma paraxanthine/caffeine (PAX/CAF) metabolic ratio. The plasma PAX/CAF metabolic ratio was similar in both groups regardless of nutritional status (0.34 +/- 0.13 [A] versus 0.30 +/- 0.11 [B]; p = 0.11). The CYP1A2 metabolic ratio was not correlated to either BMI, serum albumin or renal clearance. CYPI A2 activity, as measured by the plasma PAX/CAF ratio, was not influenced by nutritional status in elderly patients.

[Anatomo-physiological aspects of the lower urinary tract in men and modifications related to ageing]. / Aspects anatomo-physiologiques de l'appareil vésico-sphinctérien chez l'homme et modifications liées au vieillissement.

MICTURITION AND INCONTINENCE: The lower urinary tract, composed of several organs necessary for micturition, is controlled by the encephalic and peripheral centres, which have a synergic effect and coordinate the lower urinary tract. Continence is ensured by the effect of the adrenergic sympathetic nerve that increases urethral sphincter tonus and maintains low pressure in the bladder during filling. Micturition appeals to the cholinergic system mediated by the muscarinic receptors situated in the bladder. AGEING OF THE PROSTATE: Under the influence of dihydrotestosterone and growth factors, ageing of the prostate is characterized by histological modifications leading to hypertrophy, obstructing the flow of urine. AGEING OF THE BLADDER: Electronic microscopy studies have shown the presence of degenerative lesions and, on urodynamic level, are characterised by over or under-activity. Ageing of the peripheral and central nervous centres is morphological and metabolic with the production of vascular and free radicals, involving the systems that control micturition and continence. The ageing kidney has a tendency to produce more urine at night because of the functional changes that intervene in the salt and water balance regulation systems.

[Clinical manifestations of urinary disorders and their treatment in ageing men]. / Manifestations cliniques des troubles urinaires chez l'homme vieillissant et leur traitement.

PROBLEMS OF THE PROSTATE: Benign hypertrophy of the prostate (BHP), when it occurs, is manifested by an obstruction or irritation related to overactivity of the bladder. The obstructive syndrome is defined by urodynamic tests. Urge incontinence and study of the pressure-flow ratio are the tests of choice. The functional handicap and impact on quality of life are assessed using the International Prostatism Symptoms Score (I-PSS). Efficient and fairly well tolerated medical treatment has reduced the indications for surgery. It relies on alpha-blockers, 5a-reductase inhibitors and phytotherapy. When indicated, the surgical treatment of choice is endoscopic resection of the prostate. Among the non-prostatic micturition disorders, urge micturition with, in extreme cases, incontinence are due to detrusor instability. This is of multifactor origin; enhanced by the local irritation or environmental factors, it usually occurs within a context of acute or chronic pathologies. Treatment is recommended with anticholinergic agents. New molecules have recently been launched, better tolerated than oxybutinine. Electrostimulation can be a good alternative in mentally normal patients. Micturition due to excess urine may be due to overactivity of the bladder, the major risk of which is acute urine retention. It can also be observed during neurological affections such as Parkinson's disease or during administration of certain drugs. Nocturnal polyuria is a frequent problem. However, simple hygiene and dietary measures and the control of certain concomitant diseases can usually relieve the symptoms. Medical treatment relies on desmopressine.

[Clinical pharmacology and aging]. / Pharmacologie clinique et vieillissement.

Clinicians must be aware that aging can lead to changes in the pharmacokinetics and pharmacodynamics of many drugs. Drug distribution may be modified with aging secondarily to the decrease of serum albumin and to modifications of body composition (increase in the proportion of fat mass and decrease of lean mass). Hepatic metabolism of several drugs is reduced with age, especially drugs which depend of hepatic blood flow or P450 cytochroms. The incidence of renal failure increase largely with age. Glomerular filtration rate should be systematically estimated in older patients and, when needed, the doses of those drugs having significant renal elimination should be adjusted. In older patients, changes in the response to drugs can also develop, concerning specially the central nervous system (increased sensibility to any neurological effect of drugs), the cardiovascular system and the renal management of water and electrolytes. In many cases, the pharmacological changes associated to age are mild and requires no dose adjustment. However, many drugs should be adapted depending on the individual situation of each patient, particularly his renal function and nutritional state. Finally, some drugs should be avoided in older patients because of a bad effectiveness/tolerance ratio compared to alternatives.

Excess winter mortality in France: influence of temperature, influenza like illness, and residential care status.

BACKGROUND: Despite a surge of 15,000 deaths caused by the 2003 heat wave in France, the annual winter excess mortality rate remains a recurring phenomenon that is quantitatively greater than the isolated summer event. METHODS: Coefficients of Seasonal Variations in Mortality (CSVMs) were calculated using monthly mortality data from 1998 to 2007 in France. CSVM was a percentage representing the excess death rate from December to March inclusively, against average, monthly mortality from the other 8 non-winter months. Sociodemographic parameters and environmental factors were also obtained. Univariate and multivariate analyses were performed to identify risk factors of increased winter mortality. RESULTS: The data revealed an annual winter excess death of 23,836 (± 7951) (mean ± 1 standard deviation) cases. On average, CSVM in France was +14.94% (13.54 [12.03; 19.70]) (mean, median, and interquartile intervals). Multivariate analysis results revealed that several factors contributed to the CSVM: sociodemographics, such as age (CSVM higher for the population older than 75) and death location (CSVM higher in nursing homes), environmental factors, such as the severity of the winter season (per monthly minimal temperature), and estimated number of influenza-like illnesses (ILI). Correlation between observed and predicted CSVMs was extremely consistent (R(2) = 0.91). CONCLUSION: There was a fundamental belief that residents in nursing homes were well protected from cold spells and their consequences. Our results revealed this to be a mere misperception.

A short-term, multicomponent infection control program in nursing homes: a cluster randomized controlled trial.

OBJECTIVES: To assess the impact of a hygiene-encouragement program on reducing infection rates (primary end point) by 5%. DESIGN: A cluster randomized study was carried out over a 5-month period. SETTINGS AND PARTICIPANTS: Fifty nursing homes (NHs) with 4345 beds in France were randomly assigned by stratified-block randomization to either a multicomponent intervention (25 NHs) or an assessment only (25 NHs). INTERVENTION: The multicomponent intervention was targeted to caregivers and consisted of implementing a bundle of infection prevention consensual measures. Interactive educational meetings using a slideshow were organized at the intervention NHs. The NHs were also provided with color posters emphasizing hand hygiene and a kit that included hygienic products such as alcoholic-based hand sanitizers. Knowledge surveys were performed periodically and served as reminders. MEASUREMENTS: The primary end point was the total infection rate (urinary, respiratory, and gastrointestinal infections) in those infection cases classified either as definite or probable. Analyses corresponded to the underlying design and were performed according to the intention-to-treat principle. This study was registered (#NCT01069497). RESULTS: Forty-seven NHs (4515 residents) were included and followed. The incidence rate of the first episode of infection was 2.11 per 1000 resident-days in the interventional group and 2.15 per 1000 resident-days in the control group; however, the difference between the groups did not reach statistical significance in either the unadjusted (Hazard Ratio [HR] = 1.00 [95% confidence interval (CI) 0.89-1.13]; P = .93]) or the adjusted (HR = 0.99 [95% CI 0.87-1.12]; P = .86]) analysis. CONCLUSION: Disentangling the impact of this type of intervention involving behavioral change in routine practice in caregivers from the prevailing environmental and contextual determinants is often complicated and confusing to interpret the results.