Active clinical trials for "Frailty"

The objective of this study is to establish a near-real-time prospective monitoring program in Medicare, Optum and MarketScan Research data to evaluate the benefit of new cardiovascular disease (CVD) drugs for older adults with frailty. Prospective monitoring program seeks to find early effectiveness and safety signals of new drugs by updating the analysis at regular intervals as new Medicare data become available. This study specifically aims to emulate a prospective surveillance of the effectiveness and safety of non-vitamin K oral anticoagulants (NOAC) vs. a comparator, warfarin, in older adults with atrial fibrillation and different frailty status. This program will be enhanced by incorporating a novel claims-based frailty index, which has been shown useful in assessing how the benefits and harms of drug therapy vary by frailty.

This trial will take the form of a feasibility study; designed to assess the feasibility of a proposed future clinical trial in this setting. This proposed future clinical trial is proposed to assess the impact of physical activity, in the form of specialised chair based physical activity interventions, on the physiological, psychological, cognitive, social and emotional health, and functional capacity of geriatric populations with pre-existing frailty within a clinical hospital ward setting; recognising health as a holistic concept incorporating a multitude of inter-related dimensions. This feasibility study is single-centre (taking place in the Harborne Ward of the Queen Elizabeth Hospital Birmingham, Mindelsohn Way, Edgbaston, Birmingham, United Kingdom).

This intervention study is a part of the FOCUS (Frailty Management Optimization Through EIP AHA Commitments and Utilization of Stakeholders Input) project which purpose is to critically reduce the burden of frailty in Europe by assisting those partners within the European Innovation Partnership for Active Healthy Ageing (EIPAHA) with commitments focusing on early diagnosis/ screening and/or management of frailty to achieve scalability. FOCUS aims to critically reduce the burden of frailty in Europe by developing methodologies and tools to assist entities focusing on early diagnosis, screening and management of frailty to achieve scalability. Frailty is a common clinical syndrome in older adults that brings an increased risk for poor health outcomes including falls, incident disability, hospitalization and mortality. The FOCUS Consortium brings together a multidisciplinary team of specialists from 10 organizations in 6 countries - Italy, Poland, Portugal, Spain, Netherlands, United Kingdom - that will work on developing, piloting and disseminating methodologies and tools to assist entities focusing on early diagnosis, screening and management of frailty to achieve scalability. Wroclaw Medical University actively participates in all projects for the advances in science, entrepreneurship, technological innovation, both with public authorities, local governments, and enterprises. In FOCUS project, WMU is responsible for Evaluation of the project and collaborates with the others partners in Coordination of the project, Dissemination of the project, Synthesis of learning and realities of practice, Analysis and guidelines development, Creation of Network and Platform for knowledge exchange, Test of guidelines in a set of commitments (Work Package 7 - WP7). The outcomes of this proposal will offer significant potential improvements for innovative, coordinated and comprehensive community based prevention with regard to the optimisation of functional capacity tools to address pre-frailty, and for improving the management of frailty. The registered study has its own protocol developed by Wroclaw Medical University research team and will be implemented within WP7 of the FOCUS project.

The Gerontology Research Programme (GRP) in the National University Singapore's Department of Psychological Medicine, was formed to coordinate and facilitate the conduct of multi-disciplinary research on in a wide range of research on ageing and health. The establishment of the Singapore Longitudinal Aging Cohort will provide a large community-based cohort of elderly subjects for observational studies with useful clinical applications. Research synergy is achieved in terms of pooling multi-disciplinary expertise, and combining genetic, biological, environmental, behavioural, social, clinical, and health services approaches to gerontological research.

Surgery in persons of older AGE (SAGE) is an observational study of patients aged 60 years and older undergoing major colorectal surgery. That is to say we are looking at how older patients recovery following surgery, and that patients who volunteer to take part will absolutely not have any changes made to patients planned treatment or surgery. Patients (identified by their Consultant) will be asked if they would like to participate in the study, agreeing to undertake an additional questionnaire, blood test, provide a urine specimen and several basic physical tests during the pre-assessment visit taking an additional 30-45 minutes. This will not affect their treatment in any way. Participation is voluntary. At the time of the pre-assessment process the patient will then be approached by a researcher, who will explain the study in more detail and obtain written consent. The questionnaire is a combination of questions, which have been used in other similar studies and may be used to identify people who are fitter than others to undergo surgery. These questions are not too dissimilar to those that may be asked during the pre-assessment process. In fact some hospitals use some of these questions (but not usually all) routinely during a hospital admission process. Several basic physical tests will be performed: hand grip strength test and some basic walking and chair rising tests. These will be supervised by the trained researcher to ensure they are carried out safely. A small blood sample (20ml) will be obtained, ideally at the same time as blood is taken for the standard pre-operative assessment process. We will also take urine specimens. The blood sample and urine specimens will be saved for tests later. There are several potential blood and urine tests that may be related to physical frailty/impairment and the aging process. The patient will undergo surgery as planned and be discharged from hospital. No researcher will interfere with the planned care or conduct any data collection at this point. At approximately 1. 3, 6 and 12 months following surgery the patient will be asked to complete the questionnaire either in person, by phone or mail. If reviewed in a clinic at the time of their postoperative follow-up checks, then we will repeat the basic physical tests again also. The patient's notes will be reviewed by a researcher (who is also a doctor) to see what operation was performed, the length of hospital stay, and if any problems developed. The patients GP may also be contacted if additional information is required. This study, while based on several others, is the first of its kind to see how persons recover after surgery being assessed over one year. We will recruit for 18 months across two hospitals aiming to recruit 200 patients during this time.

Research questions i) How should electronic frailty index (eFI) components be combined with additional routine primary care data to develop prognostic models for predicting key outcomes of requirement for home care, falls/fractures, nursing home admission and mortality in older people with moderate or severe frailty? ii) Can model predictive performance be improved through addition of data from measures that are practical for primary care use, but not available in routine data? iii) How should risk predictions from the prognostic models be translated into a decision analytic model (DAM) to guide clinical management? iv) What is the potential cost-effectiveness of implementing interventions targeted at subgroups of older people with frailty in routine NHS care? Background Lead applicant Clegg led the eFI development, validation and national implementation. This has been translated into major UK health policy change through inclusion in the 2017/18 GP contract, which supports frailty stratification using the eFI, and UK National Health Service Long Term Plan. Aim To develop and evaluate the eFI+, a prognostic tool supplementing the original eFI including 4 integrated prognostic-decision models. The eFI+ will stratify older people with moderate or severe frailty into subgroups most likely to benefit from key interventions (community rehabilitation; falls prevention; comprehensive geriatric assessment; advance care planning). Methods Design Prognostic model development, internal validation and external validation using large datasets (ResearchOne, SAIL databank, Leeds Data Model) and cohort study data (CARE75+), with linked DAM and health economic analysis. Population Patients ≥65 with moderate or severe frailty, defined by the existing eFI. Key outcomes 12-month outcomes for prognostic models: New/increased home care package Emergency Department (ED) attendance/hospitalisation with fall/fracture Nursing home admission All-cause mortality Statistical methods i) Prognostic modelling The investigators will build 4 separate prognostic models for our 4 key outcomes by combining the eFI with additional individual-level routine data, informed by reviews to identify prognostic factors. Each model will be developed and internally validated in one large dataset, to adjust for potential overfitting, with subsequent external validation of predictive performance in a second large dataset. Separately, the investigators will use CARE75+ (n≈1,200) to investigate additional predictive value of clinical measures practical for primary care (e.g. gait speed, activities of daily living, loneliness). ii) Decision analytic model (DAM) The investigators will translate the prognostic models into a framework to support clinical decision-making, in co-production with stakeholders/PPI. The investigators will integrate prognostic models with effect size estimates from systematic reviews/meta-analyses to identify relevant thresholds of predicted risk, above which implementation of our key interventions would be warranted. iii) Health economic evaluation 12-month and long-term cost effectiveness models will be developed, informed by the DAM.

Background: In Demark we se an increasing life expectancy and an increasing incidence of esophageal cancer and gastroesophageal junction (c.esophagus), with an average age of 65 years at diagnosis time. The consequence of this is an increased number of patients in need of esophageal resection. Esophageal cancer is currently treated with chemotherapy, radiotherapy and, whenever possible, esophageal resection. This multimodal treatment has increased survival, but is also associated with significant morbidity, mortality and adverse postoperative quality of life. At present, there is no standardized risk assessment for patients with c.esophagus who have to undergo esophageal resection. This study evaluates the preoperative risk using the frailty score system, CAF (comprehensive assessment of frailty) score, which identify patients being frail or not based on an assessment of the patient's physical condition. Purpose: Investigate how many patients that are frail undergoing esophageal resection. With the assumptions that CAF score can identify frail patients and that frail patients, have an increased risk of postoperative complications. With CAF score, we believe to become better of predicting complications following esophageal resection. Method: Prospective observational study of patients with c.esophagus undergoing esophageal resection. Plan to include 60 patients over one year period. The patients are deemed frail or not with the use of CAF score, which consist of various smaller physical test and questions. Postoperativley a follow-up after 30-days, six month and 12 month. At follow-up times, data are collected on the somatic readmissions / diagnoses and vital status. Afterwards we compare complications, mortality and quality of life in frail versus non-frail patients. Side effects, risks and disadvantages: At present, there is no standardized risk assessment used for preoperative risk assessment for patients with c.esophagus undergoing esophageal resection. The introduction of CAF score, will not expose patients to a risk or side effect, since the course or treatment does not change. Economy: We consider the study to be economically justified, since we hypothesize that this would lead to fewer readmissions, days of intensive care and shorter hospitalization. Acquisition: The patients will be 60 years or older and are undergoing esophageal resection. They will receive verbal- and written information preoperatively. At the first appearance they meet our project assistant who will answer any questions. Subsequently, the patients will be asked to sign a consent form. Publication of test results / research ethics statement: The knowledge and results gained through the research will provide essential scientific information of significans for the future course and treatment of patients undergoing esophageal resection in terms of number of hospital days, intensive days and readmissions.

The European Union's Horizon 2020 project issued a Call for Action [1] in December 2013 to design, develop, disseminate and evaluate new IT technologies for use in integrative treatment processes, with emphasis on complex adult patient. Assuta Hospital submitted a proposal for this call, as part of a broad consortium of 10 participants from various European countries. The CONNECARE consortium has formulated a general model for integrative treatment, and is currently in the technological development stages, to create a smart (supportive decision) and adaptive system that supports integrative treatment processes both in the hospital and in the community for personalized treatment in complex chronic patients. The development includes a significant integrative component of self-care management by the patient and / or the primary caregiver. Following the completion of the technological development, clinical trials will be held in four organizations throughout Europe - Assuta Hospital in Ashdod in cooperation with the Maccabi community in Ashdod, two centers in Catalonia and the Groningen region in the Netherlands. The purpose of the studies is to assess the impact of the implementation of the model, processes and digital tools that will be built during the project.

Background: Over the past decades there have been seen an increase in life expectancy in Denmark. One of the consequences is that the patients who need heart surgery have a higher average age and some of these patients have a fragile physique that increases the risks of major surgery. In cardiac surgery, there are different types of scoring system for assessing the preoperative risk of death associated with surgery. Among them are EuroSCORE and STS systems the most used. This study evaluate the preoperative risk using the frailty score system, CAF (comprehensive assessment of frailty), based on an assessment of the patient's physical condition. If the patient has a lower than expected physical condition, the patient is frail. The assessment of the physical condition generated from questions about the patient's medical history and physical activity as well as performing less physical tests, consisting of strength, balance and walking speed. Purpose: A prospective observational study, who investigates how many of the patients who must undergo heart surgery, that is frail. Then compare the patients who are frail with non-frail patients in terms of complications, mortality and quality of life after the procedure. By use of CAF score the patients are scored frail or non-frail. There is planned a further study which compare degree of kidney injury in frail with non-frail patients. Our assumption is that patients which are frail, have an increased risk of complications and longer hospital stay, higher consumption of intensive days and more readmissions. Using frailty score in combination with the existing score systems EuroSCORE and STS score, are believed to be a better predictor of complications following heart surgery. Method: FICS study is a prospective observational study of patients undergoing cardiac surgery in the cardiothoracic department of Rigshospitalet. Planned to enroll 600 patients over a two year period. The study consists of various smaller physical test and questions. Which is used to assess whether the patient is frail and not frail. Postoperatively follow-up after 30 days with a phone call and after 12 months through danish data register. At the both follow-up times, data are collected on the somatic readmissions / diagnoses and vital status through the national register and review of relevant journal notes. Afterwards comparing complications and mortality. Who can enter: One patients can be included if the following criteria are met: Age> 65 years, Elective or subacute surgery, CABG (coronary artery bypass grafting),valve substitution or combination of these If one or more of the following criteria are met, the patient is not included in the study: Acute surgery, Clinical unstable, Severe neuropsychiatric impairment, Uncooperative (psychiatric diagnosis) and Re-operations. Side effects, risks and disadvantages: Today preoperative risk assessment are assessed by EuroSCORE. Introduction of CAF, frailty score will not expose patients to the risk or side effect, since the course or treatment does not change. Economy: There are considered that the study are economically justified, since hypothetically this would lead to fewer readmissions, fewer days in intensive care and shorter hospital. Acquisition: The patients will in this trial be over 65 years old and must have completed elective or subacute cardiac surgery. They will receive participant information and thus the opportunity to read about the study before the first appearance. At first appearance they meet our project assistant and get here verbal information about the study, where also questions can be answered. Subsequently, the patients will be asked to sign a consent form. Publication of test results / research ethics statement: The knowledge and results obtained through the survey will provide essential scientific information of significance for the future course and treatment of patients undergoing cardiac surgery with regard to the number of hospital days, intensive days and readmissions. Thus, the investigator believes that the study is appropriate and ethically

Frailty is a dynamic process from fit (robust) and pre-frail elderly. There is no previous study that determine the risk factors from fit to pre-frailty and pre-frailty to frailty in Indonesian elderly. This study was aimed to define the risk factors and clinical outcomes of frailty transitional status in Indonesian elderly.