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

Not Applicable

Completed

• Conditions: Dementia; Alzheimer Disease; Cognitive Impairments
• Interventions: Other: Usual care program; Other: Ability platform program

• Registration Number: NCT02746484
• Lead Sponsor: Fondazione Don Carlo Gnocchi Onlus

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2016-04-12
• Study First Submitted QC: 2016-04-20
• Study First Posted: 2016-04-21
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-16
• Last Update Posted: 2017-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual care program	Usual care program	Usual care at home program (paper and pencil cognitive activities; promotion of physical activity according to healthcare professional's advice)
Ability platform program	Ability platform program	Multi-domain at home rehabilitation program delivered through the Ability platform.

Primary Outcome Measures

Name	Time	Method
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
activities of daily living	change from baseline after 8 weeks (aMCI/AD subjects)	Activities of Daily Living Inventory (ADCS/ADL)
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 Outcome Measures

Name	Time	Method
activities of daily living	change from baseline after 12 months (aMCI/AD subjects)	Activities of Daily Living Inventory (ADCS/ADL)
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
caregiver coping strategies	change from baseline after 8 weeks and after 12 months	Coping Orientation for Problems Experienced - Brief Version (Brief COPE)
caregiver burden	change from baseline after 8 weeks and after 12 months	Caregiver Burden Inventory (CBI)
caregiver affect	change from baseline after 8 weeks and after 12 months	Positive and Negative Affect Schedule (PANAS)