View clinical trials related to Frail Elderly Syndrome.
Filter by:Introduction: With the aging of the world population and the increasing incidence of type 2 diabetes mellitus (T2DM) with age, the number of elderly individuals living with diabetes has been considerably rising. It is known that uncontrolled T2DM negatively impacts various health outcomes, including geriatric outcomes such as sarcopenia, frailty, immobility, incontinence, and infections. Current medical literature fails to establish appropriate glycemic targets for different elderly profiles. Although guidelines emphasize the need to individualize targets, there is no concise tool to identify which individuals benefit from each therapeutic approach. Data suggest that frailty is the best predictor of negative outcomes in elderly patients living with T2DM. The Clinical Frailty Scale (CFS) and the 10-minute Targeted Geriatric Assessment (TaGA-10) are validated tools for prognosis in elderly patients and for identifying frail elderly individuals. Methods: Randomized controlled trial. Elderly individuals diagnosed with T2DM at a tertiary care outpatient clinic will be included. All enrolled patients will undergo geriatric assessment using CFS, TaGA-10, and Charlson Comorbidity Index. Patients will be randomized into usual care and intervention groups, and the intervention involves providing the geriatric assessment to the care team to support their decisions. The adequacy of the therapeutic approach will be measured in one week by reviewing the consult record or interviewing the physician. The clinical impact on the frequency of hypoglycemia, falls, infections, hospitalizations, and mortality will be evaluated at 3 and 6 months by telephone interviews. Discussion: Current guidelines recommend using age, comorbidities, cognitive, and functional status to individualize therapeutic targets in elderly patients with T2DM; however, it is possible that these variables alone may not be sufficient to classify all elderly individuals in their complexity adequately. A tool with such power and easy to use in clinical practice is necessary.
Frailty, an aging-related syndrome of physiological decline characterized by marked vulnerability to adverse health outcomes, has attracted increasing attention in cardiology due to the growing elderly population with heart failure. Frail patients are mainly excluded from large cardiovascular intervention studies, and clinical trials addressing frailty and showing an impact on treatment on symptom burden, quality of life and /or outcome has been requested in recent guidelines and consensus documents. The INTEgrRated health CARE for patients with severe frailty and Heart Failure (INTERCARE-HF) is a proof-of-concept study that aims to evaluate the effect of integrated healthcare services for heart failure patients with a severe level of frailty by establishing interdisciplinary and coordinated follow-up teams across the healthcare boundaries. These teams will assess the patient's needs, goals, and risk areas, conduct advance care planning, and develop individualized treatment and follow-up plans. An open-label, non-randomized intervention study aims to recruit 20 patients and heart failure and a clinical Frailty Score (CSF) >=5. A control-group (N=40) matched on age an clinical frailty scale score will be included. The overall hypothesis is that the intervention is feasible in routine clinical practice with favorable effects on quality of life, symptoms, caregiver distress, and healthcare service utilization.
The aging of the global population presents significant social and health challenges. In Aragón, 15% of the population is between 65 and 79 years old, and the over-aging index is 16.6%, higher than the national average. This aging necessitates promoting healthy aging and maintaining functional capacity in advanced ages. Currently, 15% of the Aragonese population is potentially dependent, a figure that rises to 26% among those over 85 years old. The decline in functional capacity is due to auditory, visual, joint, and proprioceptive issues, resulting in increased vulnerability to falls, which are a significant cause of death among the elderly. The frailty syndrome, although common with aging, is not inevitable and is characterized by the loss of functional capacity and increased risk of falls and hospitalization. To assess this capacity in frail individuals, specific tools like the Mini-Motor Test, the Morton Mobility Index, and the Elderly Mobility Scale exist. The BESTest, developed in 2009, evaluates balance but is time-consuming to administer, leading to the creation of a shorter version, the Mini BESTest. However, both can be limiting for frail individuals. To address these limitations, the Frail'BESTest was developed, evaluating six balance subsystems and being suitable for frail individuals, making it a valid and sensitive tool in clinical practice. This research project aims to develop tools that identify balance problems in frail individuals with mild cognitive impairment, allowing for specific interventions to reduce the risk of falls.
This clinical trial will aim to understand the effects of the TRAK-SILVER digital platform on pre-frail and older adults living at home, assessing its impact on physical activity level, emotional variables, and overall quality of life. Participant satisfaction with the digital treatment will also be evaluated. This research will provide insight into the utility and acceptance of the digital platform as a personalised and accessible digital physiotherapy program for this population, advancing understanding in the field. The participants will undergo a 3-month physiotherapy program using the TRAK-SILVER platform or a paper guide based on their assigned group. Additionally, weekly uploads of health-promoting audiovisual content will enhance the intervention's holistic approach to improving older adults' well-being and functional capacity.
This clinical study, designed as a double-blind, randomized, placebo-controlled trial, aims to investigate the potential of nicotinamide riboside (NR) to decelerate functional decline in the elderly frail population. In animal studies, NR, which is converted to nicotinamide adenine dinucleotide (NAD), has shown potential as a neuroprotective agent, with indications of protection against amyotrophic lateral sclerosis (ALS), Alzheimer's dementia, and Parkinson's disease. Furthermore, aging is commonly associated with decreased tissue NAD levels, a phenomenon linked to premature aging and a spectrum of age-related disorders, including cardiovascular diseases and cancers. Existing preclinical and clinical research highlights the promise of NAD replenishment through enhanced DNA repair, sirtuin activity, and improved mitochondrial function. The research center has conducted two phase II clinical trials on NR for Parkinson's disease (NAD-PARK and NR-SAFE), administering up to 3000 mg of NR daily. These trials have shown promising results, indicating NR's potential as a treatment that may alter the course of the disease and possibly as neuroprotective treatment in Parkinson's disease. The NAD age trial primarily aims to determine: - The efficacy of NAD therapy in improving clinical symptoms of frailty, evaluated through standardized physical and cognitive function tests. - The safety of administering 2000 mg NR daily in an elderly frail population. The study will include 100 individuals, classified as frail based on the Fried Frailty Phenotype. Participants will be randomly assigned to receive either 2000 mg of NR daily or a placebo. Over a 52-week period, participants will undergo: - Clinical evaluations, including actigraphy and questionnaires. - Cognitive assessments. - Bio sampling. - Magnetic resonance imaging (MRI). - Positron emission tomography (FDG-PET) scanning. The outcomes of this study could potentially demonstrate that NR effectively reduces signs of frailty, offering considerable advantages to the individuals affected, their families, and society as a whole.
Aim 1: To assess the feasibility and acceptability of delivering AGE SELF CARE through virtual medical group visits by measuring recruitment rate, adherence, and participant satisfaction. Hypothesis 1: It will be feasible to recruit 12 older adults who are pre-frail. Hypothesis 2: At least 70% of participants will attend 6 of 8 group visit sessions. Hypothesis 3: At least 70% of participants will report satisfaction with the program. Aim 2: Determine the feasibility and burden of measuring frailty in this study by different instruments. Hypothesis 1: At least 70% of participants will complete portions of all frailty assessments. Hypothesis 2: Participants will not find testing to be burdensome and measures may be completed in 60 minutes or less. Hypothesis 3: Mean gait speed and frailty index will improve from baseline to post-intervention.
This study was conducted to evaluate the effect of a comprehensive health promotion educational intervention applied to family caregivers over the age of 60 on their fragility levels. The main question(s) it aims to answer are: - Does the educational intervention have a significant impact on caregivers' vulnerability? - Does the educational intervention have a significant impact on caregivers' quality of life? The population of the study consists of family members who care for individuals receiving home health services in public hospitals in Antalya city center. G power test was used to determine the number of samples and the result of the analysis on the subject; Alpha value of 0.01 for independent sample t test at 95% confidence level; Taking an effect size of 1.35 and theoretical power of 99%, the minimum total sample size was determined as 58 people, 29 for each group. It was thought that it would be appropriate to take 30% more than the calculated minimum sample number due to possible losses that may occur during the research process, and as a result, it was decided to recruit 40 people for each group. In the study, the Participant Information Form developed by the researcher, the Health Promoting Lifestyle Profile (HPLP) scale, the frailty (FRAIL) scale and the World Health Organization quality of life scale for elderly individuals will be applied to family caregivers. SPSS statistical software package will be used in the analysis of the data obtained.
A single-centre prospective study of feasibility assessing the suitability of introducing routine frailty screening in a controlled, and reproducible, outpatient department setting for Vascular Surgery patients. This study will also perform head-to-head comparisons of the prognostic value of five frailty assessment tools, selected based on the previous demonstration of their popularity and familiarity within the speciality, their designs being based on different theories of frailty and that some are endorsed by local healthcare police. Inter-user variability (patient self assessment and clinician assessment will also be compared).
Introduction: Due to the worldwide ageing population and the increasing prevalence of chronic illnesses and cognitive deficits, appropriate instruments for frailty early screening and assessment of geriatric syndromes are required. Digital tools based on artificial intelligence can help improve the evaluation and screening of health risks in the older adults. Objectives: This study aims to evaluate the effectiveness of the PRESAGE CARE questionnaire in screening geriatric syndromes among older adults and to assess its correlation with standardized test scores of the comprehensive geriatric assessment (CGA). Methods: A monocentric prospective observational study will be conducted between October 2023 and July 2024, on seniors who are in the day hospitalization service of Charles-Foix hospital in France. During the consultation with older adults, the investigators will ask the patient's home caregiver to use the PRESAGE CARE application to fill in the PRESAGE CARE questionnaire. Once the questionnaire will be completed on the application, the PRESAGE platform will automatically recorde specific risks for each senior. Subsequently, the investigators will retrieve the data from standardized tests conduct on the same day and enter the results for each patient into the platform. The primary outcome will be the correlation between standardized test scores and the risks computed by the Presage Care system for the risk of depression, the risk of undernutrition, the risk of cognitive impairment and the risk of loss of autonomy in activities of daily living. Secondary outcome will be the comparison of the Area Under the Median Curve (AUC), and the sensitivity, specificity and positive predictive values of artificial intelligence (AI)-based models on the Présage Care questionnaire.
Introduction: PRESAGE CARE has developed a solution for early detection of the risk of emergency department visits and unscheduled hospitalizations. This smartphone-based solution is used by homecare workers and family caregivers to predict the risk of emergency department visits and unscheduled hospitalization within one to two weeks. Objective: To study the feasibility of a multicenter randomized trial to assess the effects of a healthcare intervention based on the alert from the Présage Care device after discharge from hospital for patients hospitalized for heart failure (MCO and SSR). Background and participants: This is a feasibility study carried out on two hospital wards for heart failure patients aged 65 and over (MCO and SSR). Patient's relative will be asked to fill in a short questionnaire twice a week for each beneficiary, relating to the beneficiary's daily life (input time not to exceed 2 minutes). This information will be transmitted in real time to PRESAGE CARE's secure platform (health data host). The study will last 6 months, with a 3-month inclusion period and an expected average follow-up of 3 months. It is planned to include 50 to 100 patients, with the same number of caregivers, and to study recruitment rates, participant satisfaction (hospital doctors, patients, caregivers, general practitioners), drop-out rates and the usefulness of updating the PRESAGE CARE algorithms in the context of the risk of re-hospitalization heart failure patients. Data collected: In addition to inclusion data to describe the participant population, informations on emergency department visits, hospitalizations, drugs prescribed and dispensed, and long-term care status will be extracted from the hospital information system . The study will establish the usefulness of conducting a subsequent randomized multicenter study on the added value of the PRESAGE CARE system for this specific population.