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

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

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

Study Overview

• Status: Completed
• Conditions: Dementia; Alzheimer Disease; Cognitive Impairments
• Intervention / Treatment: Other: Ability platform program; Other: Usual care program

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 85 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fondazione Don Carlo Gnocchi Onlus
• Collaborators: University of Milano Bicocca

Publications and helpful links

General Publications

• 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. Epub 2011 Apr 21.
• Realdon O, Rossetto F, Nalin M, Baroni I, Cabinio M, Fioravanti R, Saibene FL, Alberoni M, Mantovani F, Romano M, Nemni R, Baglio F. Technology-enhanced multi-domain at home continuum of care program with respect to usual care for people with cognitive impairment: the Ability-TelerehABILITation study protocol for a randomized controlled trial. BMC Psychiatry. 2016 Nov 25;16(1):425. doi: 10.1186/s12888-016-1132-y.

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: April 12, 2016
• First Submitted That Met QC Criteria: April 20, 2016
• First Posted (Estimate): April 21, 2016

Study Record Updates

• Last Update Posted (Estimate): January 18, 2017
• Last Update Submitted That Met QC Criteria: January 16, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Cognition Disorders; Alzheimer Disease; Cognitive Dysfunction
• Other Study ID Numbers: FdG_AD_02