FOCUS- Frailty Management Optimization Through EIP AHA Commitments and Utilization of Stakeholders Input (FOCUS-WMU)
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|ClinicalTrials.gov Identifier: NCT03194412|
Recruitment Status : Unknown
Verified October 2017 by Donata Kurpas, Wroclaw Medical University.
Recruitment status was: Active, not recruiting
First Posted : June 21, 2017
Last Update Posted : November 1, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Frailty||Dietary Supplement: Diet /nutritional Behavioral: Physical activity Combination Product: Comprehensive therapy Behavioral: Caregivers of elderly||Not Applicable|
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.
Weight loss Exhaustion Physical Activity Walk Time Grip Strength
Robust: 0 points Pre-frail: 1-2 points Frail: 3 or more points
Method: diagnostic survey Technique: the 'surveys combined with direct measurements of patients investigated within 0, after 3 and 6 months
• Standardized questionnaires: Center for Epidemiologic Studies Depression Scale Minnesota Leisure Time Physical Activity Questionnaire Vulnerable Elders — 13 Survey Mini Nutritional Assessment Health Behaviour Inventory Montreal Cognitive Assessment Geriatric Depression Scale World Health Organization Quality of Life (short version) questionnaire Camberwell Assessment of Need Short Appraisal Schedule Barthel Scale Activities of Daily Living Instrumental Activities of Daily Living Camberwell Assessment of Need Short Appraisal Schedule Timed up and go test Beck Depression Inventory
- The questionnaire on: socio-demographic data - age, gender, marital status, living in relationship/ without relationship, level of education, place of residence, economic status; the number of hospitalizations in the last 3 years (including kind of ward); the number and kind of chronic diseases (ICD-10); the number of permanent medications; employment situation; number of traveling in the last year; having pets; number of languages the participants can speak; number of falls
- Rating of patients' difficulties in the implementation of the intervention (Did the patients perform the interventions? How often? Was it difficult to the patients?)
- Observations sheet: height, weight, BMI, hand grip strength, circumference of arm muscle, circumference of calf
- The results of laboratory tests: sodium , albumins, lymphocytes, LDL cholesterol, C reactive proteins, glomerular filtration rate, fasting glucose, thyroid hormones
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||210 participants|
|Intervention Model:||Factorial Assignment|
|Intervention Model Description:||
The group of participants involved to the study:
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||FOCUS- Frailty Management Optimization Through EIP AHA Commitments and Utilization of Stakeholders Input (WP7-WMU)|
|Actual Study Start Date :||May 19, 2017|
|Actual Primary Completion Date :||September 30, 2017|
|Estimated Study Completion Date :||December 2017|
Experimental: Diet /nutritional
Special diet for elderly. It should be rich in the appropriately amount of protein, carotenoids, vitamins, minerals, macro and micronutrients.
Dietary Supplement: Diet /nutritional
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:
The diet modification is mainly focused on adequate supply:
Experimental: Physical activity
Regular physical activity in everyday life of the elderly - exercises to improve coordination and balance, stretching exercises, strength exercises.
Behavioral: Physical activity
Worksheets for the elderly with frailty syndrome have been developed:
Other Name: regular physical activity in everyday life of the elderly
Experimental: 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)
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)
Other Name: diet/nutritional and physical activity training
Experimental: Caregivers of elderly
Education about frailty: prevention and treatment (nutrition, physical activity, dietary supplement diet).
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).
Frequency: 1 (at the beginning of stage 0, 1 and 2) Duration: 60 minutes
No Intervention: Control group
- Functional status change [ Time Frame: 6 months ]People who improved/worsened functional status according to standardized measures
- Falls change [ Time Frame: 6 months ]People who had at least one fall during the period of the intervention
- Mood change [ Time Frame: 6 months ]People who improved/worsened mood status according to standardized measures
- Nutritional status change [ Time Frame: 6 months ]People who improved /worsened nutritional status according to standardized measures
- Cognitive status change [ Time Frame: 6 months ]People who improved /worsened cognitive status according to standardized measures
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03194412
|Wroclaw Medical University|
|Wrocław, Wroclaw, Poland, 50-345|
|Principal Investigator:||Aneta Soll, MSc||Wroclaw Medical University|