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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
Sponsor:
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
Information provided by (Responsible Party):
Donata Kurpas, Wroclaw Medical University

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.


Condition or disease Intervention/treatment Phase
Frailty Dietary Supplement: Diet /nutritional Behavioral: Physical activity Combination Product: Comprehensive therapy Behavioral: Caregivers of elderly Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 210 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Intervention 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)
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

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.
Dietary Supplement: Diet /nutritional

• 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)

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
  • 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.
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)

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
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).

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


No Intervention: Control group
Without intervention



Primary Outcome Measures :
  1. Functional status change [ Time Frame: 6 months ]
    People who improved/worsened functional status according to standardized measures


Secondary Outcome Measures :
  1. Falls change [ Time Frame: 6 months ]
    People who had at least one fall during the period of the intervention

  2. Mood change [ Time Frame: 6 months ]
    People who improved/worsened mood status according to standardized measures

  3. Nutritional status change [ Time Frame: 6 months ]
    People who improved /worsened nutritional status according to standardized measures

  4. Cognitive status change [ Time Frame: 6 months ]
    People who improved /worsened cognitive status according to standardized measures



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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Poland
Wroclaw Medical University
Wrocław, Wroclaw, Poland, 50-345
Sponsors and Collaborators
Wroclaw Medical University
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
Investigators
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Principal Investigator: Aneta Soll, MSc Wroclaw Medical University

Additional Information:
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.

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Responsible Party: Donata Kurpas, Donata Kurpas, MD, PhD, Assoc. Prof., Wroclaw Medical University
ClinicalTrials.gov Identifier: NCT03194412     History of Changes
Other Study ID Numbers: 664367/FOCUS
664367/FOCUS ( Other Grant/Funding Number: EU HP and Ministry of Science and Higher Education in Poland )
First Posted: June 21, 2017    Key Record Dates
Last Update Posted: November 1, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Donata Kurpas, Wroclaw Medical University:
Frail Elderly
Geriatric Assessment
Humans
Aged
Additional relevant MeSH terms:
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Frailty
Pathologic Processes
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs