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How to best meet the needs of people with dementia with severe behavioural disturbances. Toward a respectful and cost-effective model

Periodic Reporting for period 1 - RECAGE (How to best meet the needs of people with dementia with severe behavioural disturbances. Toward a respectful and cost-effective model)

Reporting period: 2018-01-01 to 2019-06-30

The RECAGE project is centred on people with dementia (PwD), an adult age onset mental disorder with high prevalence; people with dementia living in high income countries are a vulnerable population when they enter the moderate and advanced stages, in whom they lose their autonomy and competence.
Dementia places a very heavy burden on affected people, families, communities and societies at large. The burden is at its maximum in the moderate and advanced stages of the disease, in whom the patient needs help to perform the ordinary activities of daily life (IADL and ADL). The informal carers must spend much, if not all, of their time assisting their relative.
The burden increases further when the person exhibits abnormal behaviours, the so-called Behavioural and Psychological Symptoms of Dementia (BPSD), who often put families into a crisis that lead to early nursing home placement, i.e. to the social exclusion of the patient
There is no wide consensus on the best way to cope with BPSD. A promising intervention, although not yet enough validated, is the admission – during the phases of severe agitation and/or other behavioural disturbances – to a special care unit for BPSD (SCU-B) aiming at treating BPSD and possibly discharge the person back home.
A SCU-B is a residential medical structure lying outside of a nursing home, in a general hospital or elsewhere, e.g. in a private hospital, where patients with BPSD are temporarily admitted when their behavioural disturbances are not amenable to control at home.
The goal of the RECAGE study is to adapt and scale up this intervention, but first we need to strengthen the evidence of its efficacy

The specific objectives of RECAGE are:
A. To start a prospective cohort study, comparing the activity of the centres endowed with a SCU-B (Gazzaniga, Modena, Ottestad, Genève, Mannheim) with that of the other centres lacking this structure (Thessaloniki, Mantova, Bergamo, Perugia, Paris, Berlin). The study will allow us:
• to assess the short and long-term clinical effectiveness of SCU-B on BPSD
• to measure the changes of the quality of life of the PwD/carers over time
• to explore if the SCU-B is effective in delaying institutionalisation
• to explore the cost-effectiveness of the SCU-B
• to evaluate the ethical aspects of care in the SCU-B (e.g. attitude of the staff/relatives of PwD)

B. To adapt the model in accordance with the results of the cohort study, not only regarding the main endpoints, but also comparing the experience and the different ways to work of the participating centres and the different socio-political context in which they act

C. To scale up the intervention in the countries who take part in the study, but where SCU-B are absent or sporadic as Italy and Greece
The following activities have been performed towards the achievement of the project objective:
• Preparation of a detailed protocol and manual of operation (Task 1.1)
• Preparation of Informed Consent Form in national languages (Task 1.1)
• Approval of Ethics Review Committees of the coordinating centre and enrolling institutions (Task 1.1)
• Design and development of the eCRF (Task 1.2)
• Organisation of web-based training sessions for the eCRF users (Task 1.2)
• Inclusion of 446 patients (out of 500 planned total) into the RECAGE study (Task 2.1)
• Completion of the 12 M visit by ten patients (Task 2.2)
• Release of the first complete version of the Statistical Analysis Plan (WP3)
• Release of the Data Management Plan (Task 6.3)

Furthermore, several results have been obtained in the frame of dissemination and communication of project results. In details:
• Creation of a project communication and dissemination plan
• Development of a project logo
• Setup, maintenance and regular update of a project website
• Creation of a project leaflet
• Setup, maintenance and regular update of a Facebook page
• Implementation of more than 50 communication, dissemination and awareness raising activities towards the different stakeholders (such as clinicians, patients, caregivers and general public) using a variety of dissemination tools (conferences, speeches, newsletters, TV Shows, social media activities)
• Definition of Exploitation and Sustainability Plan
The main goal of RECAGE is to strengthen the evidence base about the clinical effectiveness of the SCU-B and to explore its cost-effectiveness (a very sensitive topic which will give useful cues to whom in charge of the governance of the health care systems). Would RECAGE succeed in proving effectiveness and cost-effectiveness, SCU-B could achieve the credentials for becoming a standard intervention, that might add to the existing care pathways for PwD a useful tool, capable to cope with the frequent behavioural crises not amenable to control with the common interventions, often allowing PwD to come back to their communities. The expected evidence as regards the effectiveness and cost-effectiveness of SCU-B would be a stimulus and an aid to the health authorities.
The comparison among existing models in different European countries, the analysis of their effectiveness and economical sustainability, the attention to the ethical aspects of this condition, discussed by a group of experts in dialogue with representatives of the public, will allow us to work out a set of recommendations for establishing and running a SCU-B that will be submitted to the public and to those in charge of the healthcare systems.
The plan for establishing some pilot units in Italy and Greece will be a first step toward a general solution.