ABILITY - TelerehABILITation: TechnologY-enhanced Multi-domain at Home Continuum of Care Program
Primary Purpose
Cognitive Impairments, Dementia, Alzheimer Disease
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ability platform program
Usual care program
Sponsored by
About this trial
This is an interventional treatment trial for Cognitive Impairments
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ability platform program
Usual care program
Arm Description
Multi-domain at home rehabilitation program delivered through the Ability platform.
Usual care at home program (paper and pencil cognitive activities; promotion of physical activity according to healthcare professional's advice)
Outcomes
Primary Outcome Measures
activities of daily living
Activities of Daily Living Inventory (ADCS/ADL)
behavioral symptoms
Neuropsychiatric Inventory (NPI) score
cognitive domain (long-term memory)
Free and Cued Selective Recall Test (FCSRT) score
cognitive domain (language)
Fluency score
cognitive domain (frontal-executive functions)
Trail Making Test (TMT) score
quality of life
Dementia Quality of Life (D-QoL) Instrument
coping strategies
Coping Orientation for Problems Experienced - Brief Version (Brief COPE)
global cognitive level
Montreal Cognitive Asssessment (MoCA) score
Secondary Outcome Measures
activities of daily living
Activities of Daily Living Inventory (ADCS/ADL)
conversion rate MCI versus AD
conversion rate score
cognitive domain - long term memory
Free and Cued Selective Recall Test (FCSRT) score
cognitive domain - language
Fluency score
cognitive domain - frontal executive functions
Trail Making Test (TMT) score
quality of life
Dementia Quality of Life (D-QoL) Instrument
coping strategies
Coping Orientation for Problems Experienced - Brief Version (Brief COPE)
caregiver quality of life
Psychological Well-Being (PWB) scale
caregiver coping strategies
Coping Orientation for Problems Experienced - Brief Version (Brief COPE)
caregiver burden
Caregiver Burden Inventory (CBI)
caregiver affect
Positive and Negative Affect Schedule (PANAS)
Full Information
NCT ID
NCT02746484
First Posted
April 12, 2016
Last Updated
January 16, 2017
Sponsor
Fondazione Don Carlo Gnocchi Onlus
Collaborators
University of Milano Bicocca
1. Study Identification
Unique Protocol Identification Number
NCT02746484
Brief Title
ABILITY - TelerehABILITation: TechnologY-enhanced Multi-domain at Home Continuum of Care Program
Official Title
ABILITY - TelerehABILITation. TechnologY-enhanced Multi-domain at Home Continuum of Care Program for People With Cognitive Impairment.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione Don Carlo Gnocchi Onlus
Collaborators
University of Milano Bicocca
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Impairments, Dementia, Alzheimer Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ability platform program
Arm Type
Experimental
Arm Description
Multi-domain at home rehabilitation program delivered through the Ability platform.
Arm Title
Usual care program
Arm Type
Active Comparator
Arm Description
Usual care at home program (paper and pencil cognitive activities; promotion of physical activity according to healthcare professional's advice)
Intervention Type
Other
Intervention Name(s)
Ability platform program
Intervention Description
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
Intervention Name(s)
Usual care program
Intervention Description
Usual care at home program (paper and pencil cognitive activities; promotion of physical activity according to healthcare professional's advice)
Primary Outcome Measure Information:
Title
activities of daily living
Description
Activities of Daily Living Inventory (ADCS/ADL)
Time Frame
change from baseline after 8 weeks (aMCI/AD subjects)
Title
behavioral symptoms
Description
Neuropsychiatric Inventory (NPI) score
Time Frame
change from baseline after 8 weeks (aMCI/AD subjects)
Title
cognitive domain (long-term memory)
Description
Free and Cued Selective Recall Test (FCSRT) score
Time Frame
change from baseline after 8 weeks (aMCI/AD subjects)
Title
cognitive domain (language)
Description
Fluency score
Time Frame
change from baseline after 8 weeks (aMCI/AD subjects)
Title
cognitive domain (frontal-executive functions)
Description
Trail Making Test (TMT) score
Time Frame
change from baseline after 8 weeks (aMCI/AD subjects)
Title
quality of life
Description
Dementia Quality of Life (D-QoL) Instrument
Time Frame
change from baseline after 8 weeks (aMCI/AD subjects)
Title
coping strategies
Description
Coping Orientation for Problems Experienced - Brief Version (Brief COPE)
Time Frame
change from baseline after 8 weeks (aMCI/AD subjects)
Title
global cognitive level
Description
Montreal Cognitive Asssessment (MoCA) score
Time Frame
change from baseline after 12 months (aMCI/AD subjects)
Secondary Outcome Measure Information:
Title
activities of daily living
Description
Activities of Daily Living Inventory (ADCS/ADL)
Time Frame
change from baseline after 12 months (aMCI/AD subjects)
Title
conversion rate MCI versus AD
Description
conversion rate score
Time Frame
change from baseline after 12 months (aMCI subjects)
Title
cognitive domain - long term memory
Description
Free and Cued Selective Recall Test (FCSRT) score
Time Frame
change from baseline after 12 months (aMCI/AD subjects)
Title
cognitive domain - language
Description
Fluency score
Time Frame
change from baseline after 12 months (aMCI/AD subjects)
Title
cognitive domain - frontal executive functions
Description
Trail Making Test (TMT) score
Time Frame
change from baseline after 12 months
Title
quality of life
Description
Dementia Quality of Life (D-QoL) Instrument
Time Frame
change from baseline after 12 months
Title
coping strategies
Description
Coping Orientation for Problems Experienced - Brief Version (Brief COPE)
Time Frame
change from baseline after 12 months
Title
caregiver quality of life
Description
Psychological Well-Being (PWB) scale
Time Frame
change from baseline after 8 weeks and after 12 months
Title
caregiver coping strategies
Description
Coping Orientation for Problems Experienced - Brief Version (Brief COPE)
Time Frame
change from baseline after 8 weeks and after 12 months
Title
caregiver burden
Description
Caregiver Burden Inventory (CBI)
Time Frame
change from baseline after 8 weeks and after 12 months
Title
caregiver affect
Description
Positive and Negative Affect Schedule (PANAS)
Time Frame
change from baseline after 8 weeks and after 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
12. IPD Sharing Statement
Citations:
PubMed Identifier
21514249
Citation
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.
Results Reference
background
PubMed Identifier
27887597
Citation
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.
Results Reference
derived
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ABILITY - TelerehABILITation: TechnologY-enhanced Multi-domain at Home Continuum of Care Program
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