Frailty Clinical Trial
— FOCUS-WMUOfficial title:
FOCUS- Frailty Management Optimization Through EIP AHA Commitments and Utilization of Stakeholders Input (WP7-WMU)
Verified date | October 2017 |
Source | Wroclaw Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 210 |
Est. completion date | December 2017 |
Est. primary completion date | September 30, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years and older |
Eligibility |
Inclusion Criteria: - patients: - age = 60 years old - recognition of the pre-frail and frail (based on the scale of the Cardiovascular Health Study) - consent to participate in the study - the patients who could speaking Polish language - caregivers: - to be formal or informal caregivers of person aged = 60 years old - consent to participate in the study - caregivers who could speaking Polish language Exclusion Criteria: - patients: - age < 60 years old - lack of recognition of the pre-frail and frail (based on the scale of the Cardiovascular Health Study) - somatic state which precludes complete examination performance according to selected scales (eg. Vision disorders) - severe mental disorders or difficulties that prevent active participation in the study - the patients who could not speaking Polish language - lack of consent to participate in the study - caregivers: - not to be formal or informal caregivers of person aged = 60 years old - lack of consent to participate in the study - the caregivers who could not speaking Polish language |
Country | Name | City | State |
---|---|---|---|
Poland | Wroclaw Medical University | Wroclaw | Wroclaw |
Lead Sponsor | Collaborator |
---|---|
Wroclaw Medical University | Aston Research Centre for Healthy Ageing (ARCHA), Aveiro University, ESTUDIOS DE SOFTWARE AVANZADO Y MANTENIMIENTO DE TECNOLOGIA SOCIEDAD LIMITADA, EVERIS, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Istituto Di Ricerche Farmacologiche Mario Negri, Nursing School of Coimbra (ESEnfC), Roessingh Research and Development, University of Valencia |
Poland,
Antonio Cano, Donata Kurpas, Maria Magdalena Bujnowska-Fedak, Silvina Santana, Carol Holland, Maura Marcucci, Ana Gonzalez- Segura, Miriam Vollenbroek-Hutten, Barbara D'Avanzo, Alessandro Nobili, João Luís Al ves Apostolo, Elzbieta Bobrowicz-Campos, Ana M. Martínez-Arroyo. FOCUS: Frailty Management Optimisation through EIPAHA Commitments and Utilisation of Stakeholders' Input - an innovative European Project in elderly care. Family Medicine & Primary Care Review 2016; 18, 3: 373-376 DOI: https://doi.org/10.5114/fmpcr/63234
Piotrowicz J, Soll A, Kielar U, Zwiefka A, Guligowska A, Piglowska M, Kostka T, Kurpas D. ICT and environmental support for patients with frailty syndrome: CareWell Project, Focus Project and SUNFRAIL Project. Medical Science Pulse 2017; 11, 1: 37-43.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Functional status change | People who improved/worsened functional status according to standardized measures | 6 months | |
Secondary | Falls change | People who had at least one fall during the period of the intervention | 6 months | |
Secondary | Mood change | People who improved/worsened mood status according to standardized measures | 6 months | |
Secondary | Nutritional status change | People who improved /worsened nutritional status according to standardized measures | 6 months | |
Secondary | Cognitive status change | People who improved /worsened cognitive status according to standardized measures | 6 months |
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