FOCUS- Frailty Management Optimization Through EIP AHA Commitments and Utilization of Stakeholders Input

NCT03194412 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2017-11-01

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Diet /nutritional

• 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)

BEHAVIORAL

Physical activity

* 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_PRODUCT

Comprehensive therapy

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

BEHAVIORAL

Caregivers of elderly

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

Sponsors & Collaborators

  • University of Valencia

    collaborator OTHER
  • Roessingh Research and Development

    collaborator OTHER
  • Aston Research Centre for Healthy Ageing (ARCHA)

    collaborator UNKNOWN
  • Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

    collaborator OTHER
  • Istituto Di Ricerche Farmacologiche Mario Negri

    collaborator OTHER
  • Nursing School of Coimbra (ESEnfC)

    collaborator UNKNOWN
  • Aveiro University

    collaborator OTHER
  • EVERIS

    collaborator UNKNOWN
  • Advanced Software Studies And Maintenance Of Technology

    collaborator OTHER
  • Wroclaw Medical University

    lead OTHER

Principal Investigators

  • Aneta Soll, MSc · Wroclaw Medical University

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-19
Primary Completion
2017-09-30
Completion
2017-12-31

Countries

  • Poland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03194412 on ClinicalTrials.gov