Clinical trial NCT02746484: ABILITY - TelerehABILITation: TechnologY-enhanced Multi-domain at Home Continuum of Care Program
Official title: ABILITY - TelerehABILITation. TechnologY-enhanced Multi-domain at Home Continuum of Care Program for People With Cognitive Impairment.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Impairments
Dementia
Alzheimer Disease
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
Collaborators: name: University of Milano Bicocca
First posted: 2016-04-21
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Ability research project, funded in Italy within the Smart Cities and Smart Communities funding program (MInistry of University and Research, Operational Regional Programme, Lombardy, Axis 1, Operational Regional Programme - European Funding for Regional Development 2007-2013), aims at developing and testing the efficacy and the impact of a Personal Smart Health Community able to provide innovative trajectories for people with cognitive impairment, putting them at the core of a continuous and intertwining treatment and support from both formal (e.g. physicians) and informal (e.g. near relatives) caregivers, with special focus on home-based care.

Within this framework of the Ability project the investigators test the efficacy of the home-based motor-cognitive rehabilitation program delivered with two different approaches: the Ability platform versus the usual care program


Eligibility criteria: Inclusion Criteria:

* diagnosed as mild AD or MCI due to AD (Albert et al, 2011) according to DSM 5 diagnostic criteria (American Psychiatric Association, 2013);
* MMSE score \>18
* school attendance (≥ 3 years).

Exclusion Criteria:

* dysmetria;
* serious deficits in visual acuity, acoustic perception, and in routine communication skills.

Primary outcomes:
measure: activities of daily living
timeFrame: change from baseline after 8 weeks (aMCI/AD subjects)
measure: behavioral symptoms
timeFrame: change from baseline after 8 weeks (aMCI/AD subjects)
measure: cognitive domain (long-term memory)
timeFrame: change from baseline after 8 weeks (aMCI/AD subjects)
measure: cognitive domain (language)
timeFrame: change from baseline after 8 weeks (aMCI/AD subjects)
measure: cognitive domain (frontal-executive functions)
timeFrame: change from baseline after 8 weeks (aMCI/AD subjects)
measure: quality of life
timeFrame: change from baseline after 8 weeks (aMCI/AD subjects)
measure: coping strategies
timeFrame: change from baseline after 8 weeks (aMCI/AD subjects)
measure: global cognitive level
timeFrame: change from baseline after 12 months (aMCI/AD subjects)
Secondary outcomes:
measure: activities of daily living
timeFrame: change from baseline after 12 months (aMCI/AD subjects)
measure: conversion rate MCI versus AD
timeFrame: change from baseline after 12 months (aMCI subjects)
measure: cognitive domain - long term memory
timeFrame: change from baseline after 12 months (aMCI/AD subjects)
measure: cognitive domain - language
timeFrame: change from baseline after 12 months (aMCI/AD subjects)
measure: cognitive domain - frontal executive functions
timeFrame: change from baseline after 12 months
measure: quality of life
timeFrame: change from baseline after 12 months
measure: coping strategies
timeFrame: change from baseline after 12 months
measure: caregiver quality of life
timeFrame: change from baseline after 8 weeks and after 12 months
measure: caregiver coping strategies
timeFrame: change from baseline after 8 weeks and after 12 months
measure: caregiver burden
timeFrame: change from baseline after 8 weeks and after 12 months
measure: caregiver affect
timeFrame: change from baseline after 8 weeks and after 12 months
Other outcomes:
Locations:
Study officials:
References:
citation: Albert MS, DeKosky ST, Dickson D, Dubois B, Feldman HH, Fox NC, Gamst A, Holtzman DM, Jagust WJ, Petersen RC, Snyder PJ, Carrillo MC, Thies B, Phelps CH. The diagnosis of mild cognitive impairment due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011 May;7(3):270-9. doi: 10.1016/j.jalz.2011.03.008. Epub 2011 Apr 21.
citation: Realdon O, Rossetto F, Nalin M, Baroni I, Cabinio M, Fioravanti R, Saibene FL, Alberoni M, Mantovani F, Romano M, Nemni R, Baglio F. Technology-enhanced multi-domain at home continuum of care program with respect to usual care for people with cognitive impairment: the Ability-TelerehABILITation study protocol for a randomized controlled trial. BMC Psychiatry. 2016 Nov 25;16(1):425. doi: 10.1186/s12888-016-1132-y.