ABILITY - TelerehABILITation: TechnologY-enhanced Multi-domain at Home Continuum of Care Program

Study Overview
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Brief Summary
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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

Official Title
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ABILITY - TelerehABILITation. TechnologY-enhanced Multi-domain at Home Continuum of Care Program for People With Cognitive Impairment.

Conditions
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Cognitive Impairments, Dementia, Alzheimer Disease

Intervention / Treatment
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* Other: Ability platform program
* Other: Usual care program


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ability platform program<br>Multi-domain at home rehabilitation program delivered through the Ability platform. | Other: Ability platform program<br>* 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).<br>|
| Active Comparator: Usual care program<br>Usual care at home program (paper and pencil cognitive activities; promotion of physical activity according to healthcare professional's advice) | Other: Usual care program<br>* Usual care at home program (paper and pencil cognitive activities; promotion of physical activity according to healthcare professional's advice)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| activities of daily living | Activities of Daily Living Inventory (ADCS/ADL) | change from baseline after 8 weeks (aMCI/AD subjects) | 
| behavioral symptoms | Neuropsychiatric Inventory (NPI) score | change from baseline after 8 weeks (aMCI/AD subjects) | 
| cognitive domain (long-term memory) | Free and Cued Selective Recall Test (FCSRT) score | change from baseline after 8 weeks (aMCI/AD subjects) | 
| cognitive domain (language) | Fluency score | change from baseline after 8 weeks (aMCI/AD subjects) | 
| cognitive domain (frontal-executive functions) | Trail Making Test (TMT) score | change from baseline after 8 weeks (aMCI/AD subjects) | 
| quality of life | Dementia Quality of Life (D-QoL) Instrument | change from baseline after 8 weeks (aMCI/AD subjects) | 
| coping strategies | Coping Orientation for Problems Experienced - Brief Version (Brief COPE) | change from baseline after 8 weeks (aMCI/AD subjects) | 
| global cognitive level | Montreal Cognitive Asssessment (MoCA) score | change from baseline after 12 months (aMCI/AD subjects) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| activities of daily living | Activities of Daily Living Inventory (ADCS/ADL) | change from baseline after 12 months (aMCI/AD subjects) | 
| conversion rate MCI versus AD | conversion rate score | change from baseline after 12 months (aMCI subjects) | 
| cognitive domain - long term memory | Free and Cued Selective Recall Test (FCSRT) score | change from baseline after 12 months (aMCI/AD subjects) | 
| cognitive domain - language | Fluency score | change from baseline after 12 months (aMCI/AD subjects) | 
| cognitive domain - frontal executive functions | Trail Making Test (TMT) score | change from baseline after 12 months | 
| quality of life | Dementia Quality of Life (D-QoL) Instrument | change from baseline after 12 months | 
| coping strategies | Coping Orientation for Problems Experienced - Brief Version (Brief COPE) | change from baseline after 12 months | 
| caregiver quality of life | Psychological Well-Being (PWB) scale | change from baseline after 8 weeks and after 12 months | 
| caregiver coping strategies | Coping Orientation for Problems Experienced - Brief Version (Brief COPE) | change from baseline after 8 weeks and after 12 months | 
| caregiver burden | Caregiver Burden Inventory (CBI) | change from baseline after 8 weeks and after 12 months | 
| caregiver affect | Positive and Negative Affect Schedule (PANAS) | change from baseline after 8 weeks and after 12 months |