FOCUS- Frailty Management Optimization Through EIP AHA Commitments and Utilization of Stakeholders Input
FOCUS-WMU
1 other identifier
interventional
210
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 19, 2017
CompletedFirst Submitted
Initial submission to the registry
June 17, 2017
CompletedFirst Posted
Study publicly available on registry
June 21, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedNovember 1, 2017
October 1, 2017
4 months
June 17, 2017
October 31, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Functional status change
People who improved/worsened functional status according to standardized measures
6 months
Secondary Outcomes (4)
Falls change
6 months
Mood change
6 months
Nutritional status change
6 months
Cognitive status change
6 months
Study Arms (5)
Diet /nutritional
EXPERIMENTALSpecial diet for elderly. It should be rich in the appropriately amount of protein, carotenoids, vitamins, minerals, macro and micronutrients.
Physical activity
EXPERIMENTALRegular physical activity in everyday life of the elderly - exercises to improve coordination and balance, stretching exercises, strength exercises.
Comprehensive therapy
EXPERIMENTALSpecial diet for elderly (appropriately amount of protein, carotenoids, vitamins, minerals, macro and micronutrients) and regular physical activity in everyday life of the elderly (exercises to improve coordination and balance, stretching exercises, strength exercises)
Caregivers of elderly
EXPERIMENTALEducation about frailty: prevention and treatment (nutrition, physical activity, dietary supplement diet).
Control group
NO INTERVENTIONWithout intervention
Interventions
• Duration: * the first stage - 3 months: 12 weeks * second stage - 3 months: 12 weeks Each patient collect a detailed menu of the last two days before making the description. Then the menu is analyzed by a nutrition consultant. The role of nutrition consultant is: * make a diet modification to include the products recommended in frailty * modifying eating habits The diet modification is mainly focused on adequate supply: * vitamin D (according to Central Europe guidelines -2013 for seniors) * protein (according to European Society for Clinical Nutrition and Metabolism (ESPEN recommendations)
* Duration: * the first stage - 3 months: 12 weeks * second stage - 3 months: 12 weeks * Frequency: twice a week * Duration of each session: 60 minutes Worksheets for the elderly with frailty syndrome have been developed: * resistance exercises and strength training, which aim to improve muscle strength in the limbs * exercises aimed at improving motor coordination, flexibility and speed * stretching exercises.
Combination of special diet for elderly (as in Group 1) and regular physical activity into everyday life of the elderly (as in Group 2) Duration: * the first stage - 3 months- 12 weeks * the second stage - 3 months- 12 weeks Frequency of physical activity: twice a week Duration of each session: 60 minutes
Group: formal and informal caregivers of elderly with frailty syndrome Materials and Tools: multimedia presentation about frailty prevention and treatment (nutrition, physical activity, dietary supplement diet). Duration: * the first stage - 3 months: 12 weeks * the second stage - 3 months: 12 weeks Frequency: 1 (at the beginning of stage 0, 1 and 2) Duration: 60 minutes
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Wroclaw Medical Universitylead
- University of Valenciacollaborator
- Roessingh Research and Developmentcollaborator
- Aston Research Centre for Healthy Ageing (ARCHA)collaborator
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinicocollaborator
- Istituto Di Ricerche Farmacologiche Mario Negricollaborator
- Nursing School of Coimbra (ESEnfC)collaborator
- Aveiro Universitycollaborator
- EVERIScollaborator
- Advanced Software Studies And Maintenance Of Technologycollaborator
Study Sites (1)
Wroclaw Medical University
Wroclaw, Wroclaw, 50-345, Poland
Related Publications (2)
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, Elżbieta 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
BACKGROUNDPiotrowicz J, Soll A, Kielar U, Zwiefka A, Guligowska A, Pigłowska 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.
BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Aneta Soll, MSc
Wroclaw Medical University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Donata Kurpas, MD, PhD, Assoc. Prof.
Study Record Dates
First Submitted
June 17, 2017
First Posted
June 21, 2017
Study Start
May 19, 2017
Primary Completion
September 30, 2017
Study Completion
December 1, 2017
Last Updated
November 1, 2017
Record last verified: 2017-10
Data Sharing
- IPD Sharing
- Will not share