NCT01700556

A Trial to Support Caregivers of Patients With Dementia in Italy: the UP-TECH Project

A Randomised Controlled Trial to Improve Support Services for Caregivers of Patients With Alzheimer Disease in Italy by UPgrading Quality of Care Through the Integration of Services and the Use of New TECHnologies (The UP-TECH Project)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 438 (actual)
• Sponsor: Istituto Nazionale di Ricovero e Cura per Anziani · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The UP-TECH project aims at developing an UPgrading quality of care for Alzheimer's disease patients through the integration of services and the use of new TECHnologies in order to also improving the quality of life of their family caregivers.

Detailed description

The World Alzheimer Report indicates that, worldwide, there were 35.6 million people with dementia in 2010 and according to forecasts, this figure will reach 65.7 million in 2030 and 115.4 million in 2050. To correctly estimate the impact of the Alzheimer's Disease (AD), it should be considered that it also affects patients' families, on whom the burden of care fall. Not surprisingly, Alzheimer's disease is called a "family illness". Family caregivers of Alzheimer's patients are subject to high levels of stress: this puts them at greater risk of developing mood disorders, depression, insomnia and generally reduces their quality of life. Information technology (IT), telecommunications and electronic equipment applied to the home, can contribute to the improvement of the quality of life of Alzheimer's patients and their caregivers. However, the multidimensionality of this problem not only calls for new services, but also for a greater coordination and integration of existing community health and social care services, of the public, nonprofit and private organizations. The assumption underlying projects integrating health care and social services is to improve coordination of support, thus reducing cost and eliminating waste and inefficiencies and improving health outcomes of the patients assisted. Examples of such initiatives in the literature can be found in the United States (the "Program for All Inclusive Care for the Elderly", Branch et al, 1995), in the United Kingdom (the "Darlington Project", Challis et al, 1991), in Canada (the PRISMA project, Hebert et al, 2010) and in France (the "System for Integrated Care for Older Persons", Beland et al, 2006). Among the tools used in these studies are case management, operator training and the use of IT systems to integrate health care and social services. Building on these experiences, the UP-TECH project aims at developing innovative methodologies and new simple technologies to improve the effectiveness and efficiency of care for AD patients and their caregivers. The main objectives of the UP-TECH project are the evaluation of the improvement of the quality of life of family caregivers of people with Alzheimer's disease and the potential delay in institutionalization of these patients. The overall design of the UP-TECH project will include 450 dyads (AD patient and related caregiver) who will be randomly enrolled in three different types of intervention, defined as * usual care * UP Protocol * UP-TECH Protocol fully described below in the section: Interventions.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
OTHER	Case Manager	The following support will be provided by a case manager: At least 3 sessions of individual face-to-face counselling (housing arrangements, disease awareness, problem solving) consisting of an initial and two reinforcing sessions four and eight months after enrollment. Monthly follow-up telephone calls. Stress management training of the family caregiver and some practical items for management of patient care in the home. Information about services/aid/certification/subsidies offered by the National Health Service, by municipal social services and by local voluntary organizations. Information on health services, support connecting to GPs and health service units (medical specialists, hospital services) and social services (municipal offices and public offices of any capacity).
OTHER	Assistive Technologies	The technologies to be employed are devices already widely used and marketed, are simple to use and do not require high technical expertise for installation and maintenance. The devices will be assigned to subjects in the UP-TECH treatment group after an evaluation of the home, made by the case manager. Such technologies include e.g.: access facilitated telephone, timed drug dispenser, and housing adaptations such as anti-slip strips; home leaving sensors; sensors to detect night falls; Gas and water leak sensors, and automatic lights.
OTHER	light support	An information package illustrating the range of social and health services available in local community will be created. It will be delivered to the caregiver during home visits by the nurse.
OTHER	3 preventive home visits by a nurse	The dyads will receive three home visits by a specifically trained nurse. Home visits will occur at enrollment and after 6 and 12 months. Each visit will occur with the following steps: telephone contact between the nurse and the family caregiver, a home visit comprising the administration of the UP-TECH questionnaire, counselling/training of the caregiver regarding patient assistance, feeding, ergonomics of the home environment, covers practical aspects of patient assistance, such as daily management of drug treatment, ergonomics of the home environment, stress management and care burden. In order to provide this information to the caregiver, the nurses will receive a specific training course.

Timeline

• Start date: 2013-01-14
• Primary completion: 2014-06-07
• Completion: 2014-06-07
• First posted: 2012-10-04
• Last updated: 2020-06-25

Locations

5 sites across 1 country: Italy