FOCUS- Frailty Management Optimization Through EIP AHA Commitments and Utilization of Stakeholders Input (WP7-WMU)
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 210
- Locations
- 1
- Primary Endpoint
- Functional status change
Study Overview
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.
Detailed Description
This is a prospective intervention study. The study is expected screening about 320 participants - persons aged more than 60 years old recruited from Universities of the Third Age, day care centers, primary care centers, geriatrics out-patient clinics and from nursing homes. We are expected to enroll 270 potential participants (at least 135 participants) to 5 groups: 4 intervention groups and 1 control group without any intervention.
Patient qualification is based on criteria developed by Fried et al 2001.
Dimensions:
Weight loss Exhaustion Physical Activity Walk Time Grip Strength
INTERPRETATION:
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Diet /nutritional
Special diet for elderly. It should be rich in the appropriately amount of protein, carotenoids, vitamins, minerals, macro and micronutrients.
Intervention: Diet /nutritional (Dietary Supplement)
Physical activity
Regular physical activity in everyday life of the elderly - exercises to improve coordination and balance, stretching exercises, strength exercises.
Intervention: Physical activity (Behavioral)
Comprehensive therapy
Special 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)
Intervention: Comprehensive therapy (Combination Product)
Caregivers of elderly
Education about frailty: prevention and treatment (nutrition, physical activity, dietary supplement diet).
Intervention: Caregivers of elderly (Behavioral)
Control group
Without intervention
Outcomes
Primary Outcomes
Functional status change
Time Frame: 6 months
People who improved/worsened functional status according to standardized measures
Secondary Outcomes
- Mood change(6 months)
- Falls change(6 months)
- Cognitive status change(6 months)
- Nutritional status change(6 months)
Investigators
Donata Kurpas
Donata Kurpas, MD, PhD, Assoc. Prof.
Wroclaw Medical University