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

Primary Purpose

Frailty

Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Diet /nutritional
Physical activity
Comprehensive therapy
Caregivers of elderly
Sponsored by
Wroclaw Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Frailty focused on measuring Frail Elderly, Geriatric Assessment, Humans, Aged

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wroclaw Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

No Intervention

Arm Label

Diet /nutritional

Physical activity

Comprehensive therapy

Caregivers of elderly

Control group

Arm Description

Special diet for elderly. It should be rich in the appropriately amount of protein, carotenoids, vitamins, minerals, macro and micronutrients.

Regular physical activity in everyday life of the elderly - exercises to improve coordination and balance, stretching exercises, strength exercises.

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)

Education about frailty: prevention and treatment (nutrition, physical activity, dietary supplement diet).

Without intervention

Outcomes

Primary Outcome Measures

Functional status change
People who improved/worsened functional status according to standardized measures

Secondary Outcome Measures

Falls change
People who had at least one fall during the period of the intervention
Mood change
People who improved/worsened mood status according to standardized measures
Nutritional status change
People who improved /worsened nutritional status according to standardized measures
Cognitive status change
People who improved /worsened cognitive status according to standardized measures

Full Information

First Posted
June 17, 2017
Last Updated
October 31, 2017
Sponsor
Wroclaw Medical University
Collaborators
University of Valencia, Roessingh Research and Development, Aston Research Centre for Healthy Ageing (ARCHA), Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Istituto Di Ricerche Farmacologiche Mario Negri, Nursing School of Coimbra (ESEnfC), Aveiro University, EVERIS, Advanced Software Studies And Maintenance Of Technology
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1. Study Identification

Unique Protocol Identification Number
NCT03194412
Brief Title
FOCUS- Frailty Management Optimization Through EIP AHA Commitments and Utilization of Stakeholders Input
Acronym
FOCUS-WMU
Official Title
FOCUS- Frailty Management Optimization Through EIP AHA Commitments and Utilization of Stakeholders Input (WP7-WMU)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 19, 2017 (Actual)
Primary Completion Date
September 30, 2017 (Actual)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wroclaw Medical University
Collaborators
University of Valencia, Roessingh Research and Development, Aston Research Centre for Healthy Ageing (ARCHA), Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Istituto Di Ricerche Farmacologiche Mario Negri, Nursing School of Coimbra (ESEnfC), Aveiro University, EVERIS, Advanced Software Studies And Maintenance Of Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty
Keywords
Frail Elderly, Geriatric Assessment, Humans, Aged

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
The group of participants involved to the study: n=60 ( at least 30) to diet /nutritional - intervention group 1 n=60 ( at least 30) to physical activity - intervention group 2 n=60 ( at least 30) to comprehensive therapy (diet/nutritional+physical activity training) - intervention group 3 n=30 (at least 15) formal and informal caregivers of elderly - intervention group 4 n=60 ( at least 30) to control group without intervention - group 5 Evaluation process: Screening Evaluation (stage 1)- investigated within 0 Baseline Evaluation (stage 2) - after 3 months from 0 Final Evaluation (stage 3) - after 6 months from 0 Professionals involved in the interventions: physicians, general practitioners, physiotherapists, rehabilitation professionals, educators, nurses, volunteers, nutrition consultant.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
210 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diet /nutritional
Arm Type
Experimental
Arm Description
Special diet for elderly. It should be rich in the appropriately amount of protein, carotenoids, vitamins, minerals, macro and micronutrients.
Arm Title
Physical activity
Arm Type
Experimental
Arm Description
Regular physical activity in everyday life of the elderly - exercises to improve coordination and balance, stretching exercises, strength exercises.
Arm Title
Comprehensive therapy
Arm Type
Experimental
Arm Description
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)
Arm Title
Caregivers of elderly
Arm Type
Experimental
Arm Description
Education about frailty: prevention and treatment (nutrition, physical activity, dietary supplement diet).
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Without intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
Diet /nutritional
Intervention Description
• 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)
Intervention Type
Behavioral
Intervention Name(s)
Physical activity
Other Intervention Name(s)
regular physical activity in everyday life of the elderly
Intervention Description
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.
Intervention Type
Combination Product
Intervention Name(s)
Comprehensive therapy
Other Intervention Name(s)
diet/nutritional and physical activity training
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Caregivers of elderly
Intervention Description
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
Primary Outcome Measure Information:
Title
Functional status change
Description
People who improved/worsened functional status according to standardized measures
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Falls change
Description
People who had at least one fall during the period of the intervention
Time Frame
6 months
Title
Mood change
Description
People who improved/worsened mood status according to standardized measures
Time Frame
6 months
Title
Nutritional status change
Description
People who improved /worsened nutritional status according to standardized measures
Time Frame
6 months
Title
Cognitive status change
Description
People who improved /worsened cognitive status according to standardized measures
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aneta Soll, MSc
Organizational Affiliation
Wroclaw Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wroclaw Medical University
City
Wrocław
State/Province
Wroclaw
ZIP/Postal Code
50-345
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
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
Results Reference
background
Citation
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.
Results Reference
background
Links:
URL
https://www.termedia.pl/FOCUS-Frailty-Management-Optimisation-through-EIPAHA-Commitments-and-Utilisation-of-Stakeholders-Input-an-innovative-European-Project-in-elderly-care-,95,28467,0,1.html
Description
Family Medicine & Primary Care Review
URL
http://medicalsciencepulse.com/resources/html/article/details?id=146026
Description
Medical Science Pulse

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

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