Overview

This trial is active, not recruiting.

Conditions cognitive impairments, dementia, alzheimer disease
Treatments ability platform program, usual care program
Sponsor Fondazione Don Carlo Gnocchi Onlus
Collaborator University of Milano Bicocca
Start date April 2015
End date September 2015
Trial size 30 participants
Trial identifier NCT02746484, FdG_AD_02

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Multi-domain at home rehabilitation program delivered through the Ability platform.
ability 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).
(Active Comparator)
Usual care at home program (paper and pencil cognitive activities; promotion of physical activity according to healthcare professional's advice)
usual care program
Usual care at home program (paper and pencil cognitive activities; promotion of physical activity according to healthcare professional's advice)

Primary Outcomes

Measure
activities of daily living
time frame: change from baseline after 8 weeks (aMCI/AD subjects)
behavioral symptoms
time frame: change from baseline after 8 weeks (aMCI/AD subjects)
cognitive domain (long-term memory)
time frame: change from baseline after 8 weeks (aMCI/AD subjects)
cognitive domain (language)
time frame: change from baseline after 8 weeks (aMCI/AD subjects)
cognitive domain (frontal-executive functions)
time frame: change from baseline after 8 weeks (aMCI/AD subjects)
quality of life
time frame: change from baseline after 8 weeks (aMCI/AD subjects)
coping strategies
time frame: change from baseline after 8 weeks (aMCI/AD subjects)
global cognitive level
time frame: change from baseline after 12 months (aMCI/AD subjects)

Secondary Outcomes

Measure
activities of daily living
time frame: change from baseline after 12 months (aMCI/AD subjects)
conversion rate MCI versus AD
time frame: change from baseline after 12 months (aMCI subjects)
cognitive domain - long term memory
time frame: change from baseline after 12 months (aMCI/AD subjects)
cognitive domain - language
time frame: change from baseline after 12 months (aMCI/AD subjects)
cognitive domain - frontal executive functions
time frame: change from baseline after 12 months
quality of life
time frame: change from baseline after 12 months
Coping strategies
time frame: change from baseline after 12 months
Caregiver quality of life
time frame: change from baseline after 8 weeks and after 12 months
Caregiver coping strategies
time frame: change from baseline after 8 weeks and after 12 months
Caregiver burden
time frame: change from baseline after 8 weeks and after 12 months
Caregiver affect
time frame: change from baseline after 8 weeks and after 12 months

Eligibility Criteria

Male or female participants from 65 years up to 85 years old.

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.

Additional Information

Official title ABILITY - TelerehABILITation. TechnologY-enhanced Multi-domain at Home Continuum of Care Program for People With Cognitive Impairment.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Fondazione Don Carlo Gnocchi Onlus.