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

NCT ID: NCT01700556

Last Updated: 2020-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 438 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-14
• Study Completion Date: 2014-06-07

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.

Conditions

Alzheimer Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Usual Care

150 patient-caregivers will receive a "light support" in the form of paper brochures and 3 preventive home visits by a nurse

Group Type: ACTIVE_COMPARATOR

light support

Intervention Type: OTHER

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.

3 preventive home visits by a nurse

Intervention Type: OTHER

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.

UP Protocol

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

Group Type: EXPERIMENTAL

Case Manager

Intervention Type: OTHER

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).

3 preventive home visits by a nurse

Intervention Type: OTHER

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.

UP-TECH Protocol

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

Group Type: EXPERIMENTAL

Case Manager

Intervention Type: OTHER

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).

Assistive Technologies

Intervention Type: OTHER

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.

3 preventive home visits by a nurse

Intervention Type: OTHER

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.

Interventions

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).

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Regione Marche

OTHER

Sponsor Role: collaborator

REGIONAL HEALTH UNIT - MARCHE REGION - AREA 5 (ASUR Marche, Area Vasta 5, Distretto Sanitario San Benedetto), Italy

UNKNOWN

Sponsor Role: collaborator

Istituto Nazionale di Ricovero e Cura per Anziani

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Filippo Masera, Dr

Role: STUDY_CHAIR

Istituto Nazionale di Ricovero e Cura per Anziani (INRCA), Italy

Locations

REGIONAL HEALTH UNIT - MARCHE REGION - AREA 2 (ASUR Marche, Area Vasta 2, Distretto Sanitario Centro Ancona), Italy

Ancona, , Italy

REGIONAL HEALTH UNIT-MARCHE REGION-AREA 3 (ASUR Marche, Area Vasta 3, Distretto Sanitario Macerata), Italy

Macerata, , Italy

REGIONAL HEALTH UNIT - MARCHE REGION - AREA 1 (ASUR Marche, Area Vasta 1, Distretto Sanitario Pesaro), Italy

Pesaro, , Italy

REGIONAL HEALTH UNIT - MARCHE REGION - AREA 4 (ASUR Marche, Area Vasta 4, Distretto Sanitario Fermo), Italy

Porto San Giorgio, , Italy

REGIONAL HEALTH UNIT - MARCHE REGION - AREA 5 (ASUR Marche, Area Vasta 5, Distretto Sanitario San Benedetto), Italy

San Benedetto del Tronto, , Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 33417236 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25874654 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23714287 (View on PubMed)

Other Identifiers

INRCA-01-2012

Identifier Type: -

Identifier Source: org_study_id