Clinical trial NCT03194412: FOCUS- Frailty Management Optimization Through EIP AHA Commitments and Utilization of Stakeholders Input
Official title: FOCUS- Frailty Management Optimization Through EIP AHA Commitments and Utilization of Stakeholders Input (WP7-WMU)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Frailty
Keywords: Frail Elderly
Geriatric Assessment
Humans
Aged
Lead sponsor: Wroclaw Medical University
Sponsor class: OTHER
Collaborators: name: University of Valencia
name: Roessingh Research and Development
name: Aston Research Centre for Healthy Ageing (ARCHA)
name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
name: Istituto Di Ricerche Farmacologiche Mario Negri
name: Nursing School of Coimbra (ESEnfC)
name: Aveiro University
name: EVERIS
name: Advanced Software Studies And Maintenance Of Technology
First posted: 2017-06-21
Enrollment: 210
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
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.
Primary purpose: SUPPORTIVE_CARE

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

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

Primary outcomes:
measure: Functional status change
timeFrame: 6 months
Secondary outcomes:
measure: Falls change
timeFrame: 6 months
measure: Mood change
timeFrame: 6 months
measure: Nutritional status change
timeFrame: 6 months
measure: Cognitive status change
timeFrame: 6 months
Other outcomes:
Locations:
city: Wrocław
country: Poland
facility: Wroclaw Medical University
state: Wroclaw
Study officials:
affiliation: Wroclaw Medical University
name: Aneta Soll, MSc
role: PRINCIPAL_INVESTIGATOR
References:
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
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.