- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03194412
FOCUS- Frailty Management Optimization Through EIP AHA Commitments and Utilization of Stakeholders Input (FOCUS-WMU)
FOCUS- Frailty Management Optimization Through EIP AHA Commitments and Utilization of Stakeholders Input (WP7-WMU)
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.
Study Overview
Status
Conditions
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Wroclaw
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Wrocław, Wroclaw, Poland, 50-345
- Wroclaw Medical University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Diet /nutritional
Special diet for elderly.
It should be rich in the appropriately amount of protein, carotenoids, vitamins, minerals, macro and micronutrients.
|
• Duration:
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:
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Experimental: Physical activity
Regular physical activity in everyday life of the elderly - exercises to improve coordination and balance, stretching exercises, strength exercises.
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Worksheets for the elderly with frailty syndrome have been developed:
Other Names:
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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)
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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:
Other Names:
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Experimental: Caregivers of elderly
Education about frailty: prevention and treatment (nutrition, physical activity, dietary supplement diet).
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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:
Frequency: 1 (at the beginning of stage 0, 1 and 2) Duration: 60 minutes |
No Intervention: Control group
Without intervention
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional status change
Time Frame: 6 months
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People who improved/worsened functional status according to standardized measures
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Falls change
Time Frame: 6 months
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People who had at least one fall during the period of the intervention
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6 months
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Mood change
Time Frame: 6 months
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People who improved/worsened mood status according to standardized measures
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6 months
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Nutritional status change
Time Frame: 6 months
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People who improved /worsened nutritional status according to standardized measures
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6 months
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Cognitive status change
Time Frame: 6 months
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People who improved /worsened cognitive status according to standardized measures
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6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Aneta Soll, MSc, Wroclaw Medical University
Publications and helpful links
General Publications
- 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
- Piotrowicz 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 664367/FOCUS (Other Grant/Funding Number: EU HP and Ministry of Science and Higher Education in Poland)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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