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

S

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status

Completed

Conditions

Alzheimer Disease

Treatments

Other: Assistive Technologies
Other: 3 preventive home visits by a nurse
Other: light support
Other: Case Manager

Study type

Interventional

Funder types

Other

Identifiers

NCT01700556
INRCA-01-2012

Details and patient eligibility

About

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.

Full 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.

Enrollment

438 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

The eligibility criteria refers to the dyad.

Inclusion Criteria:

  • patient with a diagnosis of Alzheimer's Disease
  • Mini-Mental State Examination (MMSE) patients score between 10 and 20
  • patient living in the community
  • presence of family caregiver

Exclusion Criteria:

  • lack of informed consent from the Alzheimer's patient or caregiver. If the patient has been declared legally incompetent or has a support administrator appointed, informed consent will be requested from a family member or from a person appointed by a judge. In the case of natural incapacitation, verified by Alzheimer Evaluation Unit doctors, consent for the patient will be requested from the primary caregiver;
  • the presence of more severe diseases in addition to Alzheimer's or unstable chronic conditions in both the AD patient and the family caregiver, as assessed by the Alzheimer Evaluation Unit and other professionals in the health district-intention of moving out of the health district within 12 months;
  • lack of a family caregiver or a caregiver less than 18 years old

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

438 participants in 3 patient groups

Usual Care
Active Comparator group
Description:
150 patient-caregivers will receive a "light support" in the form of paper brochures and 3 preventive home visits by a nurse
Treatment:
Other: light support
Other: 3 preventive home visits by a nurse
UP Protocol
Experimental group
Description:
150 patient-caregivers provided with the systematic and comprehensive support of a case manager social worker and receiving 3 preventive home visits by a nurse
Treatment:
Other: Case Manager
Other: 3 preventive home visits by a nurse
UP-TECH Protocol
Experimental group
Description:
150 patient-caregivers provided with the systematic and comprehensive support of a case manager social worker, receiving an intervention based on assistive technologies and 3 preventive home visits by a nurse
Treatment:
Other: Assistive Technologies
Other: Case Manager
Other: 3 preventive home visits by a nurse

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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