Alzheimer Disease Clinical Trial
Official title:
ABILITY - TelerehABILITation. TechnologY-enhanced Multi-domain at Home Continuum of Care Program for People With Cognitive Impairment.
Verified date | January 2017 |
Source | Fondazione Don Carlo Gnocchi Onlus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 30 |
Est. completion date | October 2016 |
Est. primary completion date | October 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years to 85 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Fondazione Don Carlo Gnocchi Onlus | University of Milano Bicocca |
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | activities of daily living | Activities of Daily Living Inventory (ADCS/ADL) | change from baseline after 8 weeks (aMCI/AD subjects) | |
Primary | behavioral symptoms | Neuropsychiatric Inventory (NPI) score | change from baseline after 8 weeks (aMCI/AD subjects) | |
Primary | cognitive domain (long-term memory) | Free and Cued Selective Recall Test (FCSRT) score | change from baseline after 8 weeks (aMCI/AD subjects) | |
Primary | cognitive domain (language) | Fluency score | change from baseline after 8 weeks (aMCI/AD subjects) | |
Primary | cognitive domain (frontal-executive functions) | Trail Making Test (TMT) score | change from baseline after 8 weeks (aMCI/AD subjects) | |
Primary | quality of life | Dementia Quality of Life (D-QoL) Instrument | change from baseline after 8 weeks (aMCI/AD subjects) | |
Primary | coping strategies | Coping Orientation for Problems Experienced - Brief Version (Brief COPE) | change from baseline after 8 weeks (aMCI/AD subjects) | |
Primary | global cognitive level | Montreal Cognitive Asssessment (MoCA) score | change from baseline after 12 months (aMCI/AD subjects) | |
Secondary | activities of daily living | Activities of Daily Living Inventory (ADCS/ADL) | change from baseline after 12 months (aMCI/AD subjects) | |
Secondary | conversion rate MCI versus AD | conversion rate score | change from baseline after 12 months (aMCI subjects) | |
Secondary | cognitive domain - long term memory | Free and Cued Selective Recall Test (FCSRT) score | change from baseline after 12 months (aMCI/AD subjects) | |
Secondary | cognitive domain - language | Fluency score | change from baseline after 12 months (aMCI/AD subjects) | |
Secondary | cognitive domain - frontal executive functions | Trail Making Test (TMT) score | change from baseline after 12 months | |
Secondary | quality of life | Dementia Quality of Life (D-QoL) Instrument | change from baseline after 12 months | |
Secondary | coping strategies | Coping Orientation for Problems Experienced - Brief Version (Brief COPE) | change from baseline after 12 months | |
Secondary | caregiver quality of life | Psychological Well-Being (PWB) scale | change from baseline after 8 weeks and after 12 months | |
Secondary | caregiver coping strategies | Coping Orientation for Problems Experienced - Brief Version (Brief COPE) | change from baseline after 8 weeks and after 12 months | |
Secondary | caregiver burden | Caregiver Burden Inventory (CBI) | change from baseline after 8 weeks and after 12 months | |
Secondary | caregiver affect | Positive and Negative Affect Schedule (PANAS) | change from baseline after 8 weeks and after 12 months |
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