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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02746484
• Other study ID #: FdG_AD_02
• Status: Completed
• Phase: N/A
• First received: April 12, 2016
• Last updated: January 16, 2017
• Start date: April 2015
• Est. completion date: October 2016

Study information

• Verified date: January 2017
• Source: Fondazione Don Carlo Gnocchi Onlus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognition Disorders
• Cognitive Impairments
• Dementia

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Fondazione Don Carlo Gnocchi Onlus	University of Milano Bicocca

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	activities of daily living	Activities of Daily Living Inventory (ADCS/ADL)	change from baseline after 8 weeks (aMCI/AD subjects)
Primary	behavioral symptoms	Neuropsychiatric Inventory (NPI) score	change from baseline after 8 weeks (aMCI/AD subjects)
Primary	cognitive domain (long-term memory)	Free and Cued Selective Recall Test (FCSRT) score	change from baseline after 8 weeks (aMCI/AD subjects)
Primary	cognitive domain (language)	Fluency score	change from baseline after 8 weeks (aMCI/AD subjects)
Primary	cognitive domain (frontal-executive functions)	Trail Making Test (TMT) score	change from baseline after 8 weeks (aMCI/AD subjects)
Primary	quality of life	Dementia Quality of Life (D-QoL) Instrument	change from baseline after 8 weeks (aMCI/AD subjects)
Primary	coping strategies	Coping Orientation for Problems Experienced - Brief Version (Brief COPE)	change from baseline after 8 weeks (aMCI/AD subjects)
Primary	global cognitive level	Montreal Cognitive Asssessment (MoCA) score	change from baseline after 12 months (aMCI/AD subjects)
Secondary	activities of daily living	Activities of Daily Living Inventory (ADCS/ADL)	change from baseline after 12 months (aMCI/AD subjects)
Secondary	conversion rate MCI versus AD	conversion rate score	change from baseline after 12 months (aMCI subjects)
Secondary	cognitive domain - long term memory	Free and Cued Selective Recall Test (FCSRT) score	change from baseline after 12 months (aMCI/AD subjects)
Secondary	cognitive domain - language	Fluency score	change from baseline after 12 months (aMCI/AD subjects)
Secondary	cognitive domain - frontal executive functions	Trail Making Test (TMT) score	change from baseline after 12 months
Secondary	quality of life	Dementia Quality of Life (D-QoL) Instrument	change from baseline after 12 months
Secondary	coping strategies	Coping Orientation for Problems Experienced - Brief Version (Brief COPE)	change from baseline after 12 months
Secondary	caregiver quality of life	Psychological Well-Being (PWB) scale	change from baseline after 8 weeks and after 12 months
Secondary	caregiver coping strategies	Coping Orientation for Problems Experienced - Brief Version (Brief COPE)	change from baseline after 8 weeks and after 12 months
Secondary	caregiver burden	Caregiver Burden Inventory (CBI)	change from baseline after 8 weeks and after 12 months
Secondary	caregiver affect	Positive and Negative Affect Schedule (PANAS)	change from baseline after 8 weeks and after 12 months