NEWS AND EVENTS
New meeting among partners is being prepared .
September 2016 . Recent updates
During this period the enrollment has begun in three sites; Spain (Hospital Universitario de Getafe- Madrid y Hospital Universitario Monte Naranco – Asturias and Italy (Hospital Università Cattolica del Sacro Cuore)
The current state of the Project is:
- Hospital Universitario de Getafe (Spain): 151 patients
- Hospital Universitario de Monte Naranco Oviedo – Asturias (Spain): 120 patients
- Hospital Università Cattolica del Sacro Cuore (Italy): Has started enrollment
April 2016 Dissemination
The project diffusion involved the presentation of several of the results in:
February 2016. Report Conclusions
Deliverable 7 was delivered with finals results and conclusions of the observational phase study..
November 2015. FRAILCLINIC plenary meeting
A plenary meeting, with the participation of all the consortium partners, was held at Getafe, Madrid with the objective to show the interim report and prepare the second phase of FRAILCLINIC Project.
October 2015. Recent updates
The Observational Phase has finished in Italy (Ospedale San Raffaele and Università Cattolica del Sacro Cuore) and Spain (Hospital Universitario de Getafe and Hospital Monte Naranco). In total 735 participants were recruited. The recruitment in United Kingdom is ongoing. According to the time schedule we will close this phase on January 2016.
Currently both Hospital Universitario de Getafe and Hospital Monte Naranco are recruiting participants for the Intervention Phase of FRAILCLINIC Project. Since July, 56 participants have been recruited.
According to the available data the consortium has prepared a document which includes the main results: Descriptive analysis and association analysis.
May 2015. Diabetes Frail Ltd., new partner of FRAILCLINIC
The inclusion in the consortium of DIABETES FRAIL Ltd has been officially approved by the EC. Diabetes Frail, led by Prof. Alan Sinclair, has been actively participating in the project from September 2014 and is replacing IDOP- University of Bedfordshire in FRAILCLINIC.
Prof. Sinclair has been participating uninterruptedly in FRAILCLINIC, and now he will do it under the roof of his new organization, Diabetes Frail, which would become new associate partner 8 of the consortium.
December 2014. Submission of the protocol of Interventional phase
The Hospital de Getafe submitted the protocol of Interventional phase.
The principal objectives of this phase are: (a) to assess the feasibility and effectiveness of programs designed to manage frail older patients by geriatrician. This manage will be performed in high risk clinical settings (cardiology, oncology, nephrology, general surgery and emergency room); (b) determine the feasibility of implementing clinical and therapeutic approach to geriatric physician in elderly patients in high risk clinical settings by comprehensive geriatric assessment (CGA); (c) determine disability by evaluating basic and instrumental activities of daily living in frail elderly patients treated in high risk clinical settings; (d) establish functional status in frail elderly people seen in high risk clinical settings; ( e) establish mortality in frail patients included in this study; (f) obtain the rate of re-hospitalization in frail patients seen in high risk clinical settings.
The primary outcomes will be: (a) evaluate disability: It was measured by the Barthel Index for basic activities of daily living) and the Lawton index for instrumental activities of daily living; (b) Functional status and performance-based measures: Is measured by Short Physical Performance Battery (SPPB), Physical Activity Scale for the Elderly (PASE SCALE); (c) quality of life was assessed by self-reported questionnaire EuroQL 5D 5L, (d) geriatrician intervention: the impact of their intervention is measured by quantifying in a register any additional tests requested and medical advice by other specialists. This phase will include economic evaluation: (a) cost-effectiveness: The incremental cost-effectiveness ratio (ICER) was assessed by measuring the difference in health outcomes per unit cost; (b) cost-utility: is measured using the QALY (unit of measurement of preferences of individuals with regard to the quality of life that has occurred through a health intervention, combined with the years earned for a given health state).
This protocol will be uploading in Clinicaltrials.gov and we will ask the classification from AEMPS. On other hand, for this phase, the CRO will do initial visit when each centre has recruited 40% of their sample size. This visit will be face to face in the centre; previously the project manager of FRAILCLINIC Study will contact with each center to explain protocol and answering questions about this phase. The aim is to assess the quality of information of case report form (CRF) and medical records in each centre, as well as, to check the each part of the study.
October 2014. Meeting with Business & Decision
The staff of SERMAS held a meeting with CRO (Contract Research Organization) Business & Decision at Getafe (Madrid). The mean conclusions were: (a) the first visit in each centre will be thorough internet, previously the project manager of FRAILCLINIC study will contact with each center to explain protocol and answering questions about this phase. (b) The monitoring visit will be performer thorough via web. The aim is to assess the quality of information in the case report form (CRF).
Summer 2014. Recent updates
In June 2014, the Deliverable 2 related to: “Assess instruments an Questionnaires was sent to European Commission
In August 2014, the Deliverable 1 related to: “Management plan (project management, quality and risks, dissemination and evaluation” was sent to European Commission.
In September 2014, the partners from Spain, Italy and United Kingdom were trained in the CRF (Case Report Form) of the Linkare platform. Some of the subjects developed: (a) Linkcare platform overview; (b) Patient registration, program inclusion or rejection, plan and assign tasks, filling and working with forms, program discharge; (C) Other Linkcare features: Issue management, agenda view, teams and patient interaction; (d) Role-play (small teams – pairs).
May 2014. Approval of Protocol of observational phase
The protocol of observational phase was approved at Hospital Getafe and was classified as “No EPA” by AEMPS (Agencia Española de Medicamentos y Productos Sanitarios). We are currently finishing the recruitment of patients in some centers.
The objectives of this phase are: (a) To assess the prevalence of frailty in the followings settings: Emergency, Cardiology, General Surgery and Oncology; (b) To assess the feasibility of programs designed to detect frail older patients in high risk clinical settings; (c) To design the assessment instruments to be used to detect frailty, and to evaluate the effectiveness and feasibility of the programs; (d) To determine the achievements of the detection program of frail patients by level, setting of care; (e) To detect causes of non-implementation of the program.
3 March 2014. FRAILCLINIC Kick off meeting
On 3 March 2014 the FRAILCLINIC kick-off meeting took place at Luxembourg, with the participation of the EAHC and representatives of the project partners.
The welcome and the opening presentation was followed by an Introduction and overall project overview by the project coordinator and a discussion on several aspects of the project according to the items previously planned in the agenda, including the research design and methodological approach, the selection of settings in each Hospital and the selected method for including patients, the implementation plan, the frailty scales and items to be used in each setting, the outcomes for each setting as well as the core intervention and particular intervention in each setting.
The participants found the meeting very productive and all of them are keen to start their tasks in this challenging project.
This website arises from the project “FRAILCLINIC, Feasibility and effectiveness of the implementation of programs to screen and manage frail older patients in different clinical settings”, which has received funding from the European Union, in the framework of the Health Programme (2008-2013).
Dr. Leocadio Rodríguez Mañas
Jefe de Servicio de Geriatría
Hospital Universitario de Getafe
Ctra. de Toledo, Km. 12,5
Phone: +34 916 839 360 (ext. 6412)
FAX: +34 916 839 210
The content of this website represents the views of the author and it is his sole responsibility; it can in no way be taken to reflect the views of the European Commission and / or the Executive Agency for Health and Consumers or any other body of the European Union. The European Commission and / or the Executive Agency do(es) not accept responsibility for any use that may be made of the information it contains.
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