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

NCT ID: NCT02746484

Last Updated: 2017-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2016-10-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Ability platform program

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

Group Type: EXPERIMENTAL

Ability platform program

Intervention Type: 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).

Usual care program

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

Group Type: ACTIVE_COMPARATOR

Usual care program

Intervention Type: OTHER

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

Interventions

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).

Intervention Type: OTHER

Usual care program

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Milano Bicocca

OTHER

Sponsor Role: collaborator

Fondazione Don Carlo Gnocchi Onlus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

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.

Reference Type: BACKGROUND

PMID: 21514249 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27887597 (View on PubMed)

Other Identifiers

FdG_AD_02

Identifier Type: -

Identifier Source: org_study_id