Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2025-12-25 @ 9:00 PM
Study NCT ID:
NCT01700556
Status:
COMPLETED
Last Update Posted:
2020-06-25
First Post:
2012-09-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Trial to Support Caregivers of Patients With Dementia in Italy: the UP-TECH Project
Sponsor:
Istituto Nazionale di Ricovero e Cura per Anziani
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2020-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
UP-TECH
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: