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

Not Applicable

• Conditions: Frailty
• Interventions: Dietary Supplement: Diet /nutritional; Behavioral: Physical activity; Behavioral: Caregivers of elderly; Combination Product: Comprehensive therapy

• Registration Number: NCT03194412
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2017-05-19
• Study First Submitted: 2017-06-17
• Study First Submitted QC: 2017-06-20
• Study First Posted: 2017-06-21
• Primary Completion: 2017-09-30
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-31
• Last Update Posted: 2017-11-01
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 210

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Diet /nutritional	Diet /nutritional	Special diet for elderly. It should be rich in the appropriately amount of protein, carotenoids, vitamins, minerals, macro and micronutrients.
Physical activity	Physical activity	Regular physical activity in everyday life of the elderly - exercises to improve coordination and balance, stretching exercises, strength exercises.
Caregivers of elderly	Caregivers of elderly	Education about frailty: prevention and treatment (nutrition, physical activity, dietary supplement diet).
Comprehensive therapy	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)

Primary Outcome Measures

Name	Time	Method
Functional status change	6 months	People who improved/worsened functional status according to standardized measures

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Wroclaw Medical University; 🇵🇱 Wrocław, Wroclaw, Poland