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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
Fondazione Don Carlo Gnocchi Onlus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cognitive Impairments

Eligibility Criteria

65 Years - 85 Years (Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    April 12, 2016
    Last Updated
    January 16, 2017
    Sponsor
    Fondazione Don Carlo Gnocchi Onlus
    Collaborators
    University of Milano Bicocca
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    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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