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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02746484
Other study ID # FdG_AD_02
Secondary ID
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
Health authority
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.

Study Design


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
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