The economic impact of moderate stage Alzheimer's disease in Italy: evidence from the UP-TECH randomized trial.

BACKGROUND: There is consensus that dementia is the most burdensome disease for modern societies. Few cost-of-illness studies examined the complexity of Alzheimer's disease (AD) burden, considering at the same time health and social care, cash allowances, informal care, and out-of-pocket expenditure by families. METHODS: This is a comprehensive cost-of-illness study based on the baseline data from a randomized controlled trial (UP-TECH) enrolling 438 patients with moderate AD and their primary caregiver living in the community. RESULTS: The societal burden of AD, composed of public, patient, and informal care costs, was about €20,000/yr. Out of this, the cost borne by the public sector was €4,534/yr. The main driver of public cost was the national cash-for-care allowance (€2,324/yr), followed by drug prescriptions (€1,402/yr). Out-of-pocket expenditure predominantly concerned the cost of private care workers. The value of informal care peaked at €13,590/yr. Socioeconomic factors do not influence AD public cost, but do affect the level of out-of-pocket expenditure. CONCLUSION: The burden of AD reflects the structure of Italian welfare. The families predominantly manage AD patients. The public expenditure is mostly for drugs and cash-for-care benefits. From a State perspective in the short term, the advantage of these care arrangements is clear, compared to the cost of residential care. However, if caregivers are not adequately supported, savings may be soon offset by higher risk of caregiver morbidity and mortality produced by high burden and stress. The study has been registered on the website www.clinicaltrials.org ( TRIAL REGISTRATION NUMBER: NCT01700556).

The UP-TECH project, an intervention to support caregivers of Alzheimer's disease patients in Italy: preliminary findings on recruitment and caregiving burden in the baseline population.

OBJECTIVES: The paper describes recruitment results and characteristics of the UP-TECH clinical trial sample, including level of care services use, informal caregiver burden and its determinants. METHODS: UP-TECH is designed to test innovative care solutions for community-dwelling patients with moderate stage Alzheimer's disease and their caregivers in Italy. Four hundred and fifty patient-caregiver dyads were randomized into three arms receiving different combinations of services, composed of case management interventions, nurse visits, assistive technology and educational brochures. The research nurses administered a questionnaire comprising an in-depth socio-demographic assessment and several clinical scales, such as Novak's Caregiver Burden Inventory. Analyses of baseline data were conducted using uni- and bi-variate statistics. Linear regressions were computed to identify de-confounded correlates of caregiver burden. RESULTS: Four hundred and thirty-eight patient-caregiver dyads were recruited and randomized. In our sample, patients are predominantly women (71.5%), with an average age of 81.5 years and a mean Mini-Mental State Examination score of 16.2. Caregivers are mostly women (66.2%) and offspring (55.7%), with a mean caregiver burden score of 27.6. They provide more than 50 hours of care per week, while receiving an almost negligible support from public services. Factors associated with caregiver burden are female gender, kinship and the patient's behavioral disturbances. The most important factor associated with lower burden is the employment of a live-in care worker. CONCLUSION: The paper provides a comprehensive description of moderate stage Alzheimer's disease patients and their caregivers, suggesting useful markers of caregiver burden. The well-balanced randomization assures the reliability of the study data-set for prospective evaluation of care strategies.

The UP-TECH project, an intervention to support caregivers of Alzheimer's disease patients in Italy: study protocol for a randomized controlled trial.

BACKGROUND: The epidemic of Alzheimer's disease (AD) represents a significant challenge for the health care and social service systems of many developed countries. AD affects both patients and family caregivers, on whom the main burden of care falls, putting them at higher risk of stress, anxiety, mortality and lower quality of life. Evidence remains controversial concerning the effectiveness of providing support to caregivers of AD patients, through case management, counseling, training, technological devices and the integration of existing care services. The main objectives of the UP-TECH project are: 1) to reduce the care burden of family caregivers of AD patients; and 2) to maintain AD patients at home. METHODS/DESIGN: A total of 450 dyads comprising AD patients and their caregivers in five health districts of the Marche region, Italy, will be randomized into three study arms. Participants in the first study arm will receive comprehensive care and support from a case manager (an ad hoc trained social worker) (UP group). Subjects in the second study arm will be similarly supported by a case manager, but in addition will receive a technological toolkit (UP-TECH group). Participants in the control arm will only receive brochures regarding available services. All subjects will be visited at home by a trained nurse who will assess them using a standardized questionnaire at enrollment (M0), 6 months (M6) and 12 months (M12). Follow-up telephone interviews are scheduled at 24 months (M24). The primary outcomes are: 1) caregiver burden, measured using the Caregiver Burden Inventory (CBI); and 2) the actual number of days spent at home during the study period, defined as the number of days free from institutionalizations, hospitalizations and stays in an observation unit of an emergency room. DISCUSSION: The UP-TECH project protocol integrates previous evidence on the effectiveness of strategies in dementia care, that is, the use of case management, new technologies, nurse home visits and efforts toward the integration of existing services in an ambitious holistic design. The analysis of different interventions is expected to provide sound evidence of the effectiveness and cost of programs supporting AD patients in the community. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01700556.

Nursing home case-mix instruments: validation of the RUG-III system in Italy.

BACKGROUND AND AIMS: The current Italian reimbursement system for long-term care does not adequately consider the great variability in the health and functional status of older persons who are admitted to long-term care institutions. Furthermore, no procedure is implemented to monitor the quality of care provided to older residents. We conducted this study to verify whether the RUG-III (Resource Utilization Groups-version III), a tool for assessing the case-mix of nursing home residents, which is widely used in the United States and in many European countries, can be effectively used in the Italian health care system. METHODS: We administered an Italian version of the RUG-III to 1000 older residents of 11 intermediate- and long-term care institutions. We also collected objective information on the amount of care provided directly or indirectly to each resident by nurses, physical therapists, and other health professionals. RESULTS: The RUG-III 44 group classification system explained 61 and 44% of the variance in rehabilitative and nursing wage-adjusted care time, respectively. CONCLUSIONS: Our findings provide strong evidence that the RUG-III classification, applied to Italian intermediate- and long-term care institutions, provides a robust estimate of the amount of nursing and rehabilitation resources consumed by older residents.