Alzheimer Disease, Cognitive Impairments, Dementia
Conditions
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
Interventions
OTHERAbility platform program
The Ability program is an at home participant-tailored and technology-enhanced platform a) delivering tablet-based intensive (five days/a week for six weeks) motor and cognitive activities; b) monitoring from remote vital and physical health parameters (i.e., weight, Heart Rate, O2 saturation, daily steps, sleep activity).
OTHERUsual care program
Usual care at home program (paper and pencil cognitive activities; promotion of physical activity according to healthcare professional's advice)
Sponsors
University of Milano Bicocca
Fondazione Don Carlo Gnocchi Onlus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| activities of daily living | change from baseline after 8 weeks (aMCI/AD subjects) | Activities of Daily Living Inventory (ADCS/ADL) |
| behavioral symptoms | change from baseline after 8 weeks (aMCI/AD subjects) | Neuropsychiatric Inventory (NPI) score |
| cognitive domain (long-term memory) | change from baseline after 8 weeks (aMCI/AD subjects) | Free and Cued Selective Recall Test (FCSRT) score |
| cognitive domain (language) | change from baseline after 8 weeks (aMCI/AD subjects) | Fluency score |
| cognitive domain (frontal-executive functions) | change from baseline after 8 weeks (aMCI/AD subjects) | Trail Making Test (TMT) score |
| quality of life | change from baseline after 8 weeks (aMCI/AD subjects) | Dementia Quality of Life (D-QoL) Instrument |
| coping strategies | change from baseline after 8 weeks (aMCI/AD subjects) | Coping Orientation for Problems Experienced - Brief Version (Brief COPE) |
| global cognitive level | change from baseline after 12 months (aMCI/AD subjects) | Montreal Cognitive Asssessment (MoCA) score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| caregiver coping strategies | change from baseline after 8 weeks and after 12 months | Coping Orientation for Problems Experienced - Brief Version (Brief COPE) |
| activities of daily living | change from baseline after 12 months (aMCI/AD subjects) | Activities of Daily Living Inventory (ADCS/ADL) |
| caregiver affect | change from baseline after 8 weeks and after 12 months | Positive and Negative Affect Schedule (PANAS) |
| caregiver burden | change from baseline after 8 weeks and after 12 months | Caregiver Burden Inventory (CBI) |
| conversion rate MCI versus AD | change from baseline after 12 months (aMCI subjects) | conversion rate score |
| cognitive domain - long term memory | change from baseline after 12 months (aMCI/AD subjects) | Free and Cued Selective Recall Test (FCSRT) score |
| cognitive domain - language | change from baseline after 12 months (aMCI/AD subjects) | Fluency score |
| cognitive domain - frontal executive functions | change from baseline after 12 months | Trail Making Test (TMT) score |
| quality of life | change from baseline after 12 months | Dementia Quality of Life (D-QoL) Instrument |
| coping strategies | change from baseline after 12 months | Coping Orientation for Problems Experienced - Brief Version (Brief COPE) |
| caregiver quality of life | change from baseline after 8 weeks and after 12 months | Psychological Well-Being (PWB) scale |
Outcome results
None listed