Ignite Creation Date:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2026-01-04 @ 8:46 AM
Study NCT ID:
NCT03194412
Status:
UNKNOWN
Last Update Posted:
2017-11-01
First Post:
2017-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
FOCUS- Frailty Management Optimization Through EIP AHA Commitments and Utilization of Stakeholders Input
Sponsor:
Wroclaw Medical University
Organization:
Study Overview
Official Title:
FOCUS- Frailty Management Optimization Through EIP AHA Commitments and Utilization of Stakeholders Input (WP7-WMU)
Status:
UNKNOWN
Status Verified Date:
2017-10
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FOCUS-WMU
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.
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:
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
Tools:
Study questionnaires:
• 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
Patient qualification is based on criteria developed by Fried et al 2001.
Dimensions:
Weight loss Exhaustion Physical Activity Walk Time Grip Strength
INTERPRETATION:
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
Tools:
Study questionnaires:
• 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 664367/FOCUS | OTHER_GRANT | EU HP and Ministry of Science and Higher Education in Poland | View |