RECAGE is articulated in three phases:
I. The first is a prospective cohort study, comparing the activity among the Centres endowed with a SCU-B and those who lack this facility and testing the efficacy and the cost-effectiveness of the proposed intervention in seven European countries.
Two cohorts of 250 patients each will be recruited by six clinical centres endowed with a SCU-B (first cohort) and six centres lacking this structure (second cohort). The follow-up will last 3 years, during which patients will be visited every 6 months and submitted to a battery exploring the severity of the BPSD and the quality of life. All adverse events will be registered, as well as some anticipated occurrences (admissions to the general hospital for intercurrent diseases, admissions to a SCU-B pertaining to the clinical participating centre and, if any, admissions to a SCU-B not pertaining to the Consortium member, nursing home placement).
At the same time the quality of life of the primary caregivers will be measured, as well as their attitude toward dementia. A cost-effectiveness analysis will be performed comparing the cohorts. Finally, time to the nursing home placement wl be recorded and compared between the two cohorts.
II. The second phase will be devoted to adapting the model according to the results of the cohort study. Factors of relevance to the targeted country (e.g. norms, etc…) will be taken into account for the creation of recommendations for implementing the intervention where it does not exist.
III. The third phase is a plan for scaling up the intervention in the countries who take part in the study.
A. To start a prospective cohort study, comparing the activity of the centres endowed with a SCU-B of both type with that of the other centres lacking this structure. 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 (use of restraints, attitude of the staff/relatives to the PwD etc.)
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.