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

NCT02746484 | Completed

• 1 other identifier: FdG_AD_02
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Conditions

Cognitive Impairments; Dementia; Alzheimer Disease

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (11)

• activities of daily living

  change from baseline after 12 months (aMCI/AD subjects)

• conversion rate MCI versus AD

  change from baseline after 12 months (aMCI subjects)

• cognitive domain - long term memory

  change from baseline after 12 months (aMCI/AD subjects)

• cognitive domain - language

  change from baseline after 12 months (aMCI/AD subjects)

• cognitive domain - frontal executive functions

  change from baseline after 12 months

Study Arms (2)

Ability platform program

EXPERIMENTAL

Multi-domain at home rehabilitation program delivered through the Ability platform.

Other: Ability platform program

Usual care program

ACTIVE COMPARATOR

Usual care at home program (paper and pencil cognitive activities; promotion of physical activity according to healthcare professional's advice)

Other: Usual care program

Interventions

Ability platform program OTHER

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).

Ability platform program

Usual care program OTHER

Usual care at home program (paper and pencil cognitive activities; promotion of physical activity according to healthcare professional's advice)

Usual care program

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• dysmetria;
• serious deficits in visual acuity, acoustic perception, and in routine communication skills.

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead
• University of Milano Bicocca: collaborator

Related Publications (2)

• 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.

  PMID: 21514249 BACKGROUND

• 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.

  PMID: 27887597 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction; Dementia; Alzheimer Disease

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2016
• First Posted: April 21, 2016
• Study Start: April 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: January 18, 2017

Record last verified: 2017-01