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

Sponsor

Wroclaw Medical University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03194412

Collaborator

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

210

Enrollment

Location

Arms

6.4

Anticipated Duration (Months)

32.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Frailty	Dietary Supplement: Diet /nutritional Behavioral: Physical activity Combination Product: Comprehensive therapy Behavioral: Caregivers of elderly	N/A

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 Design

Study Type:

Interventional

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.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 5Evaluation 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 :

Sep 30, 2017

Anticipated Study Completion Date :

Dec 1, 2017

Arms and Interventions

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 Names: 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 Names: 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

Outcome Measures

Primary Outcome Measures

Functional status change [6 months]
People who improved/worsened functional status according to standardized measures

Secondary Outcome Measures

Falls change [6 months]
People who had at least one fall during the period of the intervention
Mood change [6 months]
People who improved/worsened mood status according to standardized measures
Nutritional status change [6 months]
People who improved /worsened nutritional status according to standardized measures
Cognitive status change [6 months]
People who improved /worsened cognitive status according to standardized measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wroclaw Medical University	Wrocław	Wroclaw	Poland	50-345

Investigators

Principal Investigator: Aneta Soll, MSc, Wroclaw Medical University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:

Donata Kurpas, Donata Kurpas, MD, PhD, Assoc. Prof., Wroclaw Medical University

ClinicalTrials.gov Identifier:

NCT03194412

Other Study ID Numbers:

664367/FOCUS
664367/FOCUS

First Posted:

Jun 21, 2017

Last Update Posted:

Nov 1, 2017

Last Verified:

Oct 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Donata Kurpas, Donata Kurpas, MD, PhD, Assoc. Prof., Wroclaw Medical University

Additional relevant MeSH terms:

Frailty

Study Results

No Results Posted as of Nov 1, 2017