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The UP-TECH project, an intervention to support caregivers of Alzheimer's disease patients in Italy : Study protocol for a randomized controlled trial

Chiatti, Carlos LU ; Masera, Filippo ; Rimland, Joseph M. ; Cherubini, Antonio ; Scarpino, Osvaldo ; Spazzafumo, Liana and Lattanzio, Fabrizia (2013) In Trials 14. p.1-11
Abstract

Background: The epidemic of Alzheimer's disease (AD) represents a significant challenge for the health care and social service systems of many developed countries. AD affects both patients and family caregivers, on whom the main burden of care falls, putting them at higher risk of stress, anxiety, mortality and lower quality of life. Evidence remains controversial concerning the effectiveness of providing support to caregivers of AD patients, through case management, counseling, training, technological devices and the integration of existing care services. The main objectives of the UP-TECH project are: 1) to reduce the care burden of family caregivers of AD patients; and 2) to maintain AD patients at home.Methods/design: A total of 450... (More)

Background: The epidemic of Alzheimer's disease (AD) represents a significant challenge for the health care and social service systems of many developed countries. AD affects both patients and family caregivers, on whom the main burden of care falls, putting them at higher risk of stress, anxiety, mortality and lower quality of life. Evidence remains controversial concerning the effectiveness of providing support to caregivers of AD patients, through case management, counseling, training, technological devices and the integration of existing care services. The main objectives of the UP-TECH project are: 1) to reduce the care burden of family caregivers of AD patients; and 2) to maintain AD patients at home.Methods/design: A total of 450 dyads comprising AD patients and their caregivers in five health districts of the Marche region, Italy, will be randomized into three study arms. Participants in the first study arm will receive comprehensive care and support from a case manager (an ad hoc trained social worker) (UP group). Subjects in the second study arm will be similarly supported by a case manager, but in addition will receive a technological toolkit (UP-TECH group). Participants in the control arm will only receive brochures regarding available services. All subjects will be visited at home by a trained nurse who will assess them using a standardized questionnaire at enrollment (M0), 6 months (M6) and 12 months (M12). Follow-up telephone interviews are scheduled at 24 months (M24). The primary outcomes are: 1) caregiver burden, measured using the Caregiver Burden Inventory (CBI); and 2) the actual number of days spent at home during the study period, defined as the number of days free from institutionalizations, hospitalizations and stays in an observation unit of an emergency room.Discussion: The UP-TECH project protocol integrates previous evidence on the effectiveness of strategies in dementia care, that is, the use of case management, new technologies, nurse home visits and efforts toward the integration of existing services in an ambitious holistic design. The analysis of different interventions is expected to provide sound evidence of the effectiveness and cost of programs supporting AD patients in the community.Trial registration: ClinicalTrials.gov: NCT01700556.

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author
publishing date
type
Contribution to journal
publication status
published
keywords
Alzheimer's disease, Caregiver burden, Integrated care, Italy, Quality of life, RCT, Technology
in
Trials
volume
14
article number
155
pages
1 - 11
publisher
BioMed Central
external identifiers
  • pmid:23714287
  • scopus:84878239989
ISSN
1745-6215
DOI
10.1186/1745-6215-14-155
language
English
LU publication?
no
id
a97422c4-20bc-4f93-93b5-e1eb88c7be80
date added to LUP
2018-08-07 15:00:52
date last changed
2020-01-13 00:51:52
@article{a97422c4-20bc-4f93-93b5-e1eb88c7be80,
  abstract     = {<p>Background: The epidemic of Alzheimer's disease (AD) represents a significant challenge for the health care and social service systems of many developed countries. AD affects both patients and family caregivers, on whom the main burden of care falls, putting them at higher risk of stress, anxiety, mortality and lower quality of life. Evidence remains controversial concerning the effectiveness of providing support to caregivers of AD patients, through case management, counseling, training, technological devices and the integration of existing care services. The main objectives of the UP-TECH project are: 1) to reduce the care burden of family caregivers of AD patients; and 2) to maintain AD patients at home.Methods/design: A total of 450 dyads comprising AD patients and their caregivers in five health districts of the Marche region, Italy, will be randomized into three study arms. Participants in the first study arm will receive comprehensive care and support from a case manager (an ad hoc trained social worker) (UP group). Subjects in the second study arm will be similarly supported by a case manager, but in addition will receive a technological toolkit (UP-TECH group). Participants in the control arm will only receive brochures regarding available services. All subjects will be visited at home by a trained nurse who will assess them using a standardized questionnaire at enrollment (M0), 6 months (M6) and 12 months (M12). Follow-up telephone interviews are scheduled at 24 months (M24). The primary outcomes are: 1) caregiver burden, measured using the Caregiver Burden Inventory (CBI); and 2) the actual number of days spent at home during the study period, defined as the number of days free from institutionalizations, hospitalizations and stays in an observation unit of an emergency room.Discussion: The UP-TECH project protocol integrates previous evidence on the effectiveness of strategies in dementia care, that is, the use of case management, new technologies, nurse home visits and efforts toward the integration of existing services in an ambitious holistic design. The analysis of different interventions is expected to provide sound evidence of the effectiveness and cost of programs supporting AD patients in the community.Trial registration: ClinicalTrials.gov: NCT01700556.</p>},
  author       = {Chiatti, Carlos and Masera, Filippo and Rimland, Joseph M. and Cherubini, Antonio and Scarpino, Osvaldo and Spazzafumo, Liana and Lattanzio, Fabrizia},
  issn         = {1745-6215},
  language     = {eng},
  month        = {05},
  pages        = {1--11},
  publisher    = {BioMed Central},
  series       = {Trials},
  title        = {The UP-TECH project, an intervention to support caregivers of Alzheimer's disease patients in Italy : Study protocol for a randomized controlled trial},
  url          = {http://dx.doi.org/10.1186/1745-6215-14-155},
  doi          = {10.1186/1745-6215-14-155},
  volume       = {14},
  year         = {2013},
}