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FRAILTOOLS: A comprehensive validation of tools to screen and diagnose frailty in different clinical and social settings to provide instruments for integrated care in older adults [FRAILTOOLS] [662887] - Project
Project abstract

There is a proved strong evidence of the usefulness of frailty as a predictive factor of relevant undesired outcomes in populations of older adults. Several studies have been published showing the utility of the concept in improving the prognostic accuracy and the prediction of different risks (hospitalization, surgical and non-surgical complications, length of stay, death, incident disability, etc) in emergency departments, cardiac surgery, surgical patients and in patients with cardiovascular disease. These studies have placed the focus in assessing population risk, while the validation process for these instruments as diagnostic or screening tools has been usually neglected.FRAILTOOLS aims to assess the usefulness as screening and diagnosis tools of some selected instruments to detect frailty in both clinical (Hospital and Primary Care) and social (nursing homes) settings, providing diagnostic algorithms clinically sound. Target groups are all of those older adults at risk for frailty (pre-frail) plus those that are frail and are at risk for developing disability. According to the published prevalence of these two conditions, the target population concerned by this project represent around 40-50% of older people older than 65 and 60-70% of people older than 75. Once determined the best tools of screening and diagnosis in different settings of care, we will reach conclusions for this people wherever the level of care they need and currently use. The benefit will expand to the Health Systems and Social Care as it will provide validated instruments that are necessary to provide an appropriate care for older adults by means of a comprehensive, continued, coordinated and integrated care.FRAILTOOLS consortium involves 6 of the most renowned partners in research on ageing and frailty from Spain, UK, Italy, France and Poland, plus the support of a number of highly relevant collaborating stakeholders fully committed with the project.

Summary of context, overal objectives, strategic, relevance and contribution of the action


From the second half of the 20th century, life expectancy has increased in developed countries, reaching a mean age of 82 years in countries such as Spain, France and Italy. According to age grouping, Europe is now the continent with the largest proportion of older people and with a higher dependency rate. According to predictions of 2060 this tendency will be maintained.
From the point of view of health and social care, the older population has increased requirements, needing specialized care to approach the complexity of their comorbidities. On the other hand, as life expectancy increases, the proportion of older people with any kind of disability rises, which in turn increases the need for long term care facilities.
Frailty is the main risk factor for appearance disability, this syndrome describes a reduction in the individual’s capacity to respond to stressors, due to a reduced functional reserve. Frailty is the condition that associates more frequently to mortality among community dwelling older adults, followed by organ failure, cancer and terminal dementia. This condition is also related to other adverse outcomes such as: falls, morbidity, disability, polypharmacy and use of medical consults, hospitalization and institutionalization.
Many studies have demonstrated the utility of certain assessment tools to evaluate frailty in populations, however the individual risk for disability has not been properly evaluated, which is the main interest in day to day clinical and social settings.
Evaluate the usefulness of frailty scales as frailty detection instruments in clinical and social settings is the main objective of FRAILTOOLS project. It´s an original initiative; relevant, by focusing its efforts on the main risk factor for disability; pertinent, concentrating on providing screening and diagnostic tools for frailty in those settings where its prevalence is the highest and where efforts in prevention could make a significant change in the trend towards disability.

General objective:
To assess the usefulness as screening and diagnosis tools of some selected instruments to detect frailty in both clinical (Hospital and Primary Care) and social (nursing homes) settings, providing diagnostic algorithms clinically sound.

Contribution:
FRAILTOOLS also contributes to the initiative of the European’s Commission on Frailty, Integrated care and multi-chronic conditions by:
1) the application of coordinated and innovative preventive measures,
2) development and implantation of screening and early diagnostic programs of frailty, including the optimization of functional capacity and the development of guidelines to manage frailty,
3) improving healthcare systems,
4) implementing health promotion strategies, and
5) facilitating the exchange of Good Clinical Practice and expanding knowledge networks, and potentiating innovation in healthcare at a European level.

Methods and means

This is an observational, longitudinal and prospective study.
The participants will be recruited in Spain (FIB HUG), Italy (Centro Medicina dell’Invecchiamento (CEMI)/ Università Cattolica del Sacro Cuore), France (Gérontopôle de Toulouse), United Kingdom (Prof. Sinclair) and Polland (Department of Internal Medicine and Gerontology (DIMG) and Division of Internal Medicine of the University Hospital of the JUMC).

The total sample will be of 1.940 subjects, each participating centre will have to recruit a total of 388 patients, corresponding to 97 subjects in each clinical setting by centre.

People 75 years or older will be enrolled in the different settings where the project will be carried out. They will be selected consecutively until reaching the sample size pre-determined by country and setting of care. The settings of care will be: In-Hospital Geriatric wards, hospital outpatient offices, Primary Care and Nursing Homes. Who sign the informed consent after accepting their participation.

General exclusion criteria will be:
• Subjects with a MMSE score less than 20 points or having a terminal illness (life expectancy < 6 months).
• Subjects included from the hospital ward (Acute Geriatric Unit and Outpatient Geriatric Consultation) and primary care will have additional exclusion criteria: obtain less than 90 points in the Barthel index.
• Subjects seen in a nursing home setting will be excluded if they obtain less than 40 points in the Barthel index.

Follow-up:
The follow-up will be of up to 18 months. As a prompt for the participant, a telephone call will take place at month 6 after the inclusion to assess whether any falls have occurred. At 12 and up to 18 months, a personal interview with each participant will take place to register data on functional status (SPPB, Barthel and Lawton indexes) and cognitive status (MMSE). Mortality data will be taken from the national mortality records.

Work performed during the reporting period

Besides Project Coordination and Financial management activities (see below), the main activities carried out during the M19 and M36 of the project (1st October 2016 – 30st April 2018) were related to the implementation of a multisite observational study in Spain, Italy, France, Poland and United Kingdom.
- Based on the existing CFR template in paper form, design and implementation of Electronic Case Report Form or eCFR
- Incorporation of the UK site (Aston University) to the study: setup of the site implementing the study in UK and local training of professionals involved in its implementation in UK
- Recruitment and follow up of patients in all sites (Spain, Poland, Italy, France, UK)
- Record of outcomes in all sites (Spain, Poland, Italy, France, UK)

The main output achieved so far and their potential impact and use by target group (including benefits)

By M36, recruitment target was reached, with data useful for analysis for the 92% of recruited patients. The 6-month follow up finalised in all sites, but 12-month and 18-month follow-up visits are still ongoing (to be finished in all sites before October 1st, 2018).

At this stage, raise-awareness activities have been done to disseminate the project and its approach amongst Geriatricians, General Practitioners and Nursing Homes doctors, as well as Medical Community in general. More in depth use of the project results for this target group as well as other target groups (Hospital, Health Centres and Nursing Homes Managers: Policy makers and Public Administrators; General Public) will only be possible once the analysis of results is in place.

Achieved outcomes compared to the expected outcomes

At this stage, we don’t have enough sample size in the follow-up to define the best or adequate instrument to classify frailty in Hospitals, Primary Care and Nursing Homes and to create sequential algorithm for the diagnosis of frailty along the settings. Final analysis of data will provide these results.

Dissemination and evaluation activities carried out so far and their major results

DISSEMINATION ACTIVITIES

Although the main dissemination activities will take place at the end of the project, the project itself, the Study Protocol and the Preliminary results have been presented in several conferences and workshops:

• SUNFRAIL Transnational Workshop. March 22nd, 2016. Bologna, Italy. Presentation of the Project’s Protocol.
• Twentieth International Association of Gerontology and Geriatrics (IAGG) World Congress and 5th International Conference on Frailty and Sarcopenia Research - ICFSR2016. Philadelphia, PA, USA. April 28th-29th, 2016. The project was presented in the communication: “A comprehensive validation of frailty assessment tools to screen and diagnose frailty in different clinical and social settings”.
Poster: FRAILTOOLS : A comprehensive validation of frailty assessment tools to screen and diagnose frailty in different clinical and social settings”, M. Javier, C. Palumbo, M Ballesteros, M. Checa, J. A. Carnicero, B. Vellas, M. Cesari, R. Bernabei, F. Landi, T. Grodzicki, A. Kantoch, A. Parnicka, A. Sinclair, L. Rodríguez Mañas (Spain, France, Italy, Poland, United Kingdom).
• Seventh National Meeting of the Spanish Society of Geriatric Medicine (SEMEG, in its Spanish acronym). Santander, Spain. November 10th-12th, 2016. The project was presented in the communication: “Evaluación de herramientas de diagnóstico de fragilidad en diferentes medios asistenciales – estudio FRAILTOOLS”
• IV Conference of the polish geriatric college, Cracow (Poland), March 10th 2017. Oral communication
• International Conference on Frailty & Sarcopenia Research. Barcelona, Spain. April 27th-28th, 2017. Symposium
• EIP-AHA Coordination meeting for Health Programme projects, Valencia (Spain), 28th June 2017.
• XIII Congress of the Polish Society of Gerontology, Cracow (Poland), 17-18th November 2017. Poster communication
• The conference of preventive cardiology, Cracow (Poland). 17th November 2017. Oral presentation
• WCO-IOF-ESCEO Krakow 2018 - World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases, Cracow (Poland). 19th-22nd April 2018. Oral presentation
• Eight National Meeting of the Spanish Society of Geriatric Medicine (SEMEG, in its Spanish acronym). Barcelona, Spain. April 11th-13th, 2018. Oral communication (nominated to the award of best communication of the congress)

EVALUATION ACTIVITIES

Besides regular interaction of FIBHUG team, as technical coordinator (responsible of WP1 Task 1.1), CHUT obtained specific feedback via 2 questionnaires sent by e-mail to the project managers for each partner. The first questionnaire was circulated in M20 and was mostly related to the status of sites preparation, which had been the most critical activity up to that time. The second questionnaire, circulated in M36, focused on recruitment and patients’ follow up.

With regards to progress indicators, the project have largely surpassed the established target in all settings; output indicators are being developed as expected too, thus setting the ground to achieve the project objectives.

Details
Start date: 01/05/2015
End date: 31/12/2018
Duration: 36 month(s)
Current status: Finalised
Programme title: 3rd Health Programme (2014-2020)
EC Contribution: € 1 124 463,00
Portfolio: Ageing