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.
Keywords: Alzheimer disease; Italy; RCT; assistive technology; caregiver burden; integrated care; quality of life.