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

FOCUS- Frailty Management Optimization Through EIP AHA Commitments and Utilization of Stakeholders Input (WP7-WMU)

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03194412
Acronym
FOCUS-WMU
Enrollment
210
Registered
2017-06-21
Start date
2017-05-19
Completion date
2017-12-31
Last updated
2017-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Frailty

Keywords

Frail Elderly, Geriatric Assessment, Humans, Aged

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

Interventions

DIETARY_SUPPLEMENTDiet /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)

BEHAVIORALPhysical 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.

COMBINATION_PRODUCTComprehensive 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

BEHAVIORALCaregivers 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

Sponsors

University of Valencia
CollaboratorOTHER
Roessingh Research and Development
CollaboratorOTHER
Aston Research Centre for Healthy Ageing (ARCHA)
CollaboratorUNKNOWN
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
CollaboratorOTHER
Istituto Di Ricerche Farmacologiche Mario Negri
CollaboratorOTHER
Nursing School of Coimbra (ESEnfC)
CollaboratorUNKNOWN
Aveiro University
CollaboratorOTHER
EVERIS
CollaboratorUNKNOWN
Advanced Software Studies And Maintenance Of Technology
CollaboratorOTHER
Wroclaw Medical University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Functional status change6 monthsPeople who improved/worsened functional status according to standardized measures

Secondary

MeasureTime frameDescription
Falls change6 monthsPeople who had at least one fall during the period of the intervention
Mood change6 monthsPeople who improved/worsened mood status according to standardized measures
Nutritional status change6 monthsPeople who improved /worsened nutritional status according to standardized measures
Cognitive status change6 monthsPeople who improved /worsened cognitive status according to standardized measures

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026