Clinical trials

Impact of Obesity on Sarcopenia Prevalence and Severity in Elderly Adults Recovering from Femoral Neck Fractures: A Prospective Study Introduction Age-related muscle loss, or sarcopenia, which includes reductions in both muscle mass and function, is increasingly recognized as a critical health issue in the elderly. Sarcopenia is associated with frailty, disability, and increased mortality. With its rising prevalence, obesity further complicates aging, leading to a condition termed "sarcopenic obesity" (SO), where sarcopenia coexists with obesity. This combination amplifies risks for physical disability, falls, and fractures in older adults. Although sarcopenia and obesity individually contribute to adverse health outcomes, their combined impact on recovery from hip fractures, particularly femoral neck fractures, is under-researched. Hip fractures severely impact the elderly, with over 40% failing to regain pre-fracture functionality and a mortality rate above 35% within three years post-fracture. This study aims to assess the impact of obesity on sarcopenia prevalence and severity in older adults recovering from femoral neck fractures, addressing an essential gap in understanding SO's role in post-fracture rehabilitation outcomes. Objectives * To evaluate the prevalence and severity of sarcopenia among normal-weight versus obese elderly adults post-femoral neck fracture. * To investigate the association between sarcopenic obesity and functional recovery. * To determine whether obesity modifies sarcopenia's impact on rehabilitation outcomes. Risk-Benefit Statement The study entails minimal risk, as all procedures are non-invasive and consistent with routine rehabilitation practices. The potential benefits include enhanced understanding of sarcopenia's effect on hip fracture recovery, which may inform improved rehabilitation practices. Comprehensive health assessments may also benefit participants' post-fracture care. Study Design Overview This prospective observational study includes hospitalized elderly patients undergoing rehabilitation post-femoral neck fracture. After obtaining informed consent, participants will complete an initial assessment, including demographic information, medical history, cognitive status, and anthropometric measurements. Blood samples will be collected for biochemical markers. Stratification and Assessment: Patients will be categorized into normal-weight and obese groups. Comprehensive assessments, including cognitive function, mobility, frailty, muscle strength, and nutritional status, will establish a baseline for studying sarcopenia and obesity's impact on rehabilitation outcomes. Population and Criteria: Sample Size: Up to 300 participants Inclusion Criteria: * Age 60-85 * Recent femoral neck fracture (within the past year) * Ability to provide informed consent Exclusion Criteria: * Inability to comply with study requirements * History of neurodegenerative or psychiatric conditions, recent major surgeries (excluding femoral neck fracture), or conditions affecting muscle metabolism Procedures: Baseline Evaluation: * Cognitive Function: Mini-Mental State Examination (MMSE) * Anthropometric Measurements: BMI from height and weight * Functional Independence (FIM): Level of independence in daily activities * Mobility (Up \& Go Test): Indicator of balance and mobility * Frailty and Muscle Strength: Handgrip strength, SARC-F questionnaire, Muscle Strength and Reflex Assessment (MSRA) * Nutritional Status: Mini Nutritional Assessment (MNA) * Laboratory Tests: CRP, calcium, vitamin D, CBC Post-Rehabilitation Evaluation: After rehabilitation, participants will repeat baseline assessments to determine changes in sarcopenia severity and functional status. Unscheduled Visits: Participants may request evaluations outside the scheduled timeline, documented by the investigator as necessary. Statistical Analysis * Descriptive Analysis: Mean and standard deviations for continuous data, frequencies for categorical data. * Comparative Analysis: Independent t-tests to compare normal-weight and obese groups, dependent t-tests for within-group changes. * Univariate Analysis: Chi-square or Fisher's exact tests with a significance level of P \< 0.05. Ethics and Confidentiality This study will adhere to the Declaration of Helsinki, ICH-GCP guidelines, and applicable regulations. Informed consent will be obtained from all participants, and confidentiality measures will protect patient privacy, with data limited to authorized personnel and anonymized in reports. Institutional Review Board (IRB) Approval IRB approval will be obtained from the Israeli Ministry of Health, following ICH-GCP guidelines. The IRB will oversee the study protocol, consent forms, and all participant materials. Data Storage and Study Termination Data will be securely stored, with

Impact of Care Team and Surfaces on the Spread of Resistant Bacteria in a Specialized Complex Nursing Unit for MDR Pathogen Carriers Background Multi-drug resistant (MDR) bacteria present a severe clinical and epidemiological challenge, typically managed through strict isolation and continuous monitoring. Transmission patterns among long-term care patients remain unclear. At "Shmuel Harofe" Geriatric Hospital, a dedicated MDR skilled care department was established to reduce infection risks in other hospital settings. It's uncertain if patients in this dedicated unit are more exposed to new bacterial colonizations. Contamination may stem from surfaces in rooms or shared spaces, or from the care team. Research Objectives 1. To assess whether care team members working in MDR units serve as vectors for infection via skin carriage or personal items. 2. Analyze the presence of resistant bacteria on surfaces in both private and shared spaces within the unit to understand infection transmission risks. Hypotheses 1. The MDR unit care team does not broadly carry resistant pathogens on their skin or items and does not significantly transmit infections. 2. Surface contamination will be mostly confined to patient rooms, with limited cases on shared surfaces. Study Design Comparative cross-sectional study with a retrospective cohort component. Study Population 1. Care Team: All staff in Shmuel Harofe's MDR department (doctors, nursing staff, medical, sanitary, and cleaning staff). 2. Surfaces in Departments: Surfaces in MDR patients' rooms and shared areas in the dedicated MDR unit. Surfeces will be revised acording to a test sampels. Methods and Materials 1. Staff Sampling: Swabs for CRE and VRE carriage will be collected from hands, facial skin, bags, shoes, cell phones, glasses, and ID badges at the start and end of shifts in the MDR unit. 2. Surface Sampling: Samples from patient environments (e.g., bed railings, cabinets, light switches) and shared areas (e.g., dining tables, door handles, keyboards, and public phones). 3. Clinical Data Collection: Epidemiological data (age, gender, functional status, medical background, length of stay) for statistical analysis. Statistical Analysis: * Comparative analysis of bacterial carriage among staff in the MDR unit versus similar wards. * Analysis of bacterial carriage frequency on surfaces in the MDR unit versus other wards using logistic regression models to assess the relationship between surface type and contamination levels. Ethics Informed consent will be obtained from staff for sample collection, with data anonymity preserved. Potential Contributions The study aims to clarify the roles of care staff and surfaces in transmitting resistant bacteria in dedicated units. Insights into transmission mechanisms may aid in developing improved protocols for patient and staff protection and provide recommendations for hygiene and control procedures in healthcare settings.

Mortality Risk Assessment by Skilled Caregivers Compared to Existing Validated Tools in Skilled Nursing Departments at Shmuel Harofeh Geriatric Hospital Background The elderly population in Israel and globally is growing, increasing demand for medical services, particularly palliative care. Recommendations from 2016 emphasized the need for geriatric and skilled nursing departments to focus on end-of-life care, but implementation has been limited. High mortality and frequent readmissions are reported in long-term care, yet accurate mortality prediction tools for elderly patients remain limited. Improved mortality prediction can help identify patients who would benefit from palliative care and reduce unnecessary interventions. Research Objectives 1. Assess life expectancy of patients in skilled nursing departments. 2. Compare the effectiveness of various tools in predicting six-month mortality. Hypothesis Caregiver assessments will more accurately predict mortality than current validated tools. Study Design Type: Prospective cohort study. Location: Shmuel Harofeh Hospital Study Population Approximately 250 patients admitted to skilled nursing departments at Shmuel Harofeh Hospital. Recruitment Period: Two years. Follow-up Period: Up to one year. Methods Epidemiological and clinical data (age, comorbidities, functional and cognitive status, lab results) will be collected. Mortality risk will be assessed using: 1. Validated Tools: Including the MITCHELL scale (for patients with advanced dementia) and the POROCK scale (for institutionalized patients). 2. Caregiver Assessment: Subjective life expectancy estimates by attending geriatricians and nursing staff within three days of admission and again 7-10 days later. An external geriatrician will also provide an assessment based on brief, non-invasive observation. Data Processing Data will be coded, entered into an electronic dataset, and undergo statistical analysis after collection. No interventions beyond routine care are included. Ethical Considerations As an observational study without intervention, a waiver for informed consent was granted. Importance of Research Skilled nursing facilities increasingly need to provide palliative care for elderly patients. This study aims to improve mortality prediction methods, helping to identify patients for end-of-life care, ultimately enhancing care quality, and reducing costs by avoiding unnecessary hospitalizations and treatments.

Mortality and Rehospitalization Risk Assessment by Skilled Caregivers Compared to Existing Tools in Acute Geriatric Departments Background The elderly population in Israel and worldwide is steadily increasing, leading to greater demand for medical services, including palliative care. In 2019, individuals aged 65+ accounted for 64% of hospital admissions and 70% of hospital days in Israel. Approximately 19% of these were readmissions, a rate that increases with age. Effective tools for identifying patients at high risk of rehospitalization and mortality are lacking, which, if improved, could benefit patients through targeted palliative and end-of-life care. Enhanced tools could reduce unnecessary interventions, improve patient well-being, and alleviate economic burdens on healthcare. Research Objectives 1. Evaluate mortality and rehospitalization rates in acute geriatric departments. 2. Identify risk factors for rehospitalization and mortality in acutely hospitalized elderly patients. 3. Compare the effectiveness of skilled caregiver assessments versus validated prediction tools for mortality and rehospitalization within one year. Hypotheses 1. Mortality and rehospitalization rates in acute geriatric departments are comparable to those in internal medicine. 2. Multiple factors-such as age, family support, comorbidities, functional and cognitive status-correlate with mortality risk. 3. Skilled caregiver assessments predict mortality and rehospitalization more accurately than existing validated tools. Study Design Type: Prospective cohort observational study. Location: Shmuel Harofe Hospital. Study Population Participants are elderly patients admitted to acute geriatric departments at Shmuel Harofe Hospital for acute conditions. Approximately 600 participants will be recruited, with an additional 200-300 if statistical analysis reveals trends. Recruitment Period: Two years. Follow-up Period: Up to one year post-admission. Methods and Materials Data will be collected on demographic, functional, cognitive, and emotional factors, as well as clinical history, hospital admissions, comorbidities, and lab results. Predictive assessments will include: 1. Mortality Prediction using the WALTER Index for the elderly. 2. Rehospitalization Risk using the LACE Index, validated for 30-day readmission risk. 3. Subjective Caregiver Assessments from geriatric specialists and nursing supervisors, estimating life expectancy and 30-day, 3-month, and 1-year rehospitalization risk. Data Analysis Data will be coded and statistically analyzed without interventions outside of standard care. The WALTER and LACE indices will utilize existing clinical data. Ethical Considerations As this is an observational study without intervention, a waiver for informed consent was granted. Importance of Research Early identification of high-risk patients will enable preventive interventions, support transitions to palliative care where appropriate, and promote advance directives, ultimately improving patient care and reducing healthcare costs by preventing costly, unnecessary readmissions and interventions.