A Trial to Support Caregivers of Patients With Dementia in Italy: the UP-TECH Project
UP-TECH
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)
1 other identifier
interventional
438
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable alzheimer-disease
Started Jan 2013
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 21, 2012
CompletedFirst Posted
Study publicly available on registry
October 4, 2012
CompletedStudy Start
First participant enrolled
January 14, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 7, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 7, 2014
CompletedJune 25, 2020
June 1, 2020
1.4 years
September 21, 2012
June 23, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Caregiver Burden Inventory
"Caregiver Burden Inventory" (CBI). A previous Italian study estimated that the level of burden of caregivers living with relatives suffering from Alzheimer type of dementia, as measured by the CBI of Novak et al (1989), is equal to 32.5, with a standard deviation equal to 18 (Marvardi et al, 2005). It is therefore assumed that the planned sample size is large enough to detect an effect on the CBI score as low as 24, with a standard deviation equal to 12, in the treatment group and a null effect in the controls. The statistical power was fixed at 80%, with a 0.05 level of significance and a drop-out rate equal to 15%. A CBI score of 24 coincides with a "sentinel" level beyond which it is suggested that caregivers need to receive additional support from the health and social services.
one year
Proportion of days spent at home by the AD patient in the past year
This outcome is calculated by subtracting, from the calendar year, the number of days of inpatient hospitalization, emergency room visits with a brief stay in the Intensive Observation Unit and institutionalization in an assisted residence facility, care homes and/or nursing homes. The hypothesis that this outcome is the same in the treated and the untreated populations will be tested. The calculation has been made considering a type 1 error (error α) of 0.05, using a one tailed t-test and assuming a 10% difference between values. Regarding this as the smallest effect of clinical relevance, a sample of 150 patients per treatment group will be adequate considering a statistical power equal to 80% and a drop-out rate equal to 15%.
one year
Secondary Outcomes (2)
Quality of Life Questionnaire, SF12
one year
Analysis of resource consumption
one year
Study Arms (3)
Usual Care
ACTIVE COMPARATOR150 patient-caregivers will receive a "light support" in the form of paper brochures and 3 preventive home visits by a nurse
UP Protocol
EXPERIMENTAL150 patient-caregivers provided with the systematic and comprehensive support of a case manager social worker and receiving 3 preventive home visits by a nurse
UP-TECH Protocol
EXPERIMENTAL150 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
Interventions
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).
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
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
Related Publications (3)
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.
PMID: 33417236DERIVEDChiatti 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.
PMID: 25874654DERIVEDChiatti 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.
PMID: 23714287DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Filippo Masera, Dr
Istituto Nazionale di Ricovero e Cura per Anziani (INRCA), Italy
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 21, 2012
First Posted
October 4, 2012
Study Start
January 14, 2013
Primary Completion
June 7, 2014
Study Completion
June 7, 2014
Last Updated
June 25, 2020
Record last verified: 2020-06