Clinical trial NCT01700556: A Trial to Support Caregivers of Patients With Dementia in Italy: the UP-TECH Project
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Keywords: Alzheimer Disease
Family Caregiver
Caregiver Burden
Home Care Services
Assistive Technologies
Lead sponsor: Istituto Nazionale di Ricovero e Cura per Anziani
Sponsor class: OTHER
Collaborators: name: Regione Marche
name: REGIONAL HEALTH UNIT - MARCHE REGION - AREA 5 (ASUR Marche, Area Vasta 5, Distretto Sanitario San Benedetto), Italy
First posted: 2012-10-04
Enrollment: 438
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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

Primary outcomes:
measure: Caregiver Burden Inventory
timeFrame: one year
measure: Proportion of days spent at home by the AD patient in the past year
timeFrame: one year
Secondary outcomes:
measure: Quality of Life Questionnaire, SF12
timeFrame: one year
measure: Analysis of resource consumption
timeFrame: one year
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: REGIONAL HEALTH UNIT - MARCHE REGION - AREA 2 (ASUR Marche, Area Vasta 2, Distretto Sanitario Centro Ancona), Italy
city: Macerata
country: Italy
facility: REGIONAL HEALTH UNIT-MARCHE REGION-AREA 3 (ASUR Marche, Area Vasta 3, Distretto Sanitario Macerata), Italy
city: Pesaro
country: Italy
facility: REGIONAL HEALTH UNIT - MARCHE REGION - AREA 1 (ASUR Marche, Area Vasta 1, Distretto Sanitario Pesaro), Italy
city: Porto San Giorgio
country: Italy
facility: REGIONAL HEALTH UNIT - MARCHE REGION - AREA 4 (ASUR Marche, Area Vasta 4, Distretto Sanitario Fermo), Italy
city: San Benedetto del Tronto
country: Italy
facility: REGIONAL HEALTH UNIT - MARCHE REGION - AREA 5 (ASUR Marche, Area Vasta 5, Distretto Sanitario San Benedetto), Italy
Study officials:
affiliation: Istituto Nazionale di Ricovero e Cura per Anziani (INRCA), Italy
name: Filippo Masera, Dr
role: STUDY_CHAIR
References:
citation: Gonzalez-Fraile E, Ballesteros J, Rueda JR, Santos-Zorrozua B, Sola I, McCleery J. Remotely delivered information, training and support for informal caregivers of people with dementia. Cochrane Database Syst Rev. 2021 Jan 4;1(1):CD006440. doi: 10.1002/14651858.CD006440.pub3.
citation: Chiatti C, Furneri G, Rimland JM, Demma F, Bonfranceschi F, Cassetta L, Masera F, Cherubini A, Corsonello A, Lattanzio F; UP-TECH research group. The economic impact of moderate stage Alzheimer's disease in Italy: evidence from the UP-TECH randomized trial. Int Psychogeriatr. 2015 Sep;27(9):1563-72. doi: 10.1017/S104161021500040X. Epub 2015 Apr 15.
citation: Chiatti C, Masera F, Rimland JM, Cherubini A, Scarpino O, Spazzafumo L, Lattanzio F; UP-TECH research group. The UP-TECH project, an intervention to support caregivers of Alzheimer's disease patients in Italy: study protocol for a randomized controlled trial. Trials. 2013 May 28;14:155. doi: 10.1186/1745-6215-14-155.