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

Trials

on behalf of the UP-TECH research group¹  Fabrizia Lattanzio¹  Liana Spazzafumo¹  Osvaldo Scarpino¹  Antonio Cherubini¹  Joseph M Rimland¹  Filippo Masera¹  Carlos Chiatti¹ 

[1] Italian National Research Center on Aging (INRCA), Ancona, Italy

关键词: Italy;    RCT;    Integrated care;    Quality of life;    Caregiver burden;    Technology;    Alzheimer’s disease;   

Others  :  1093858
DOI  :  10.1186/1745-6215-14-155

 received in 2012-12-04, accepted in 2013-05-14,  发布年份 2013

【 摘 要 】

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: http://NCT01700556 webcite

【 授权许可】

   
2013 Chiatti et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

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