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

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ClinicalTrials.gov Identifier: NCT02746484
Recruitment Status : Completed
First Posted : April 21, 2016
Last Update Posted : January 18, 2017
Sponsor:
Collaborator:
University of Milano Bicocca
Information provided by (Responsible Party):
Fondazione Don Carlo Gnocchi Onlus

Study Description
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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


Condition or disease Intervention/treatment Phase
Cognitive Impairments Dementia Alzheimer Disease Other: Ability platform program Other: Usual care program Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: ABILITY - TelerehABILITation. TechnologY-enhanced Multi-domain at Home Continuum of Care Program for People With Cognitive Impairment.
Study Start Date : April 2015
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Ability platform program
Multi-domain at home rehabilitation program delivered through the Ability platform.
 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).
Active Comparator: Usual care program
Usual care at home program (paper and pencil cognitive activities; promotion of physical activity according to healthcare professional's advice)
 Other: Usual care program
Usual care at home program (paper and pencil cognitive activities; promotion of physical activity according to healthcare professional's advice)


Outcome Measures
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Primary Outcome Measures :
  1. activities of daily living [ Time Frame: change from baseline after 8 weeks (aMCI/AD subjects) ]
    Activities of Daily Living Inventory (ADCS/ADL)

  2. behavioral symptoms [ Time Frame: change from baseline after 8 weeks (aMCI/AD subjects) ]
    Neuropsychiatric Inventory (NPI) score

  3. cognitive domain (long-term memory) [ Time Frame: change from baseline after 8 weeks (aMCI/AD subjects) ]
    Free and Cued Selective Recall Test (FCSRT) score

  4. cognitive domain (language) [ Time Frame: change from baseline after 8 weeks (aMCI/AD subjects) ]
    Fluency score

  5. cognitive domain (frontal-executive functions) [ Time Frame: change from baseline after 8 weeks (aMCI/AD subjects) ]
    Trail Making Test (TMT) score

  6. quality of life [ Time Frame: change from baseline after 8 weeks (aMCI/AD subjects) ]
    Dementia Quality of Life (D-QoL) Instrument

  7. coping strategies [ Time Frame: change from baseline after 8 weeks (aMCI/AD subjects) ]
    Coping Orientation for Problems Experienced - Brief Version (Brief COPE)

  8. global cognitive level [ Time Frame: change from baseline after 12 months (aMCI/AD subjects) ]
    Montreal Cognitive Asssessment (MoCA) score


Secondary Outcome Measures :
  1. activities of daily living [ Time Frame: change from baseline after 12 months (aMCI/AD subjects) ]
    Activities of Daily Living Inventory (ADCS/ADL)

  2. conversion rate MCI versus AD [ Time Frame: change from baseline after 12 months (aMCI subjects) ]
    conversion rate score

  3. cognitive domain - long term memory [ Time Frame: change from baseline after 12 months (aMCI/AD subjects) ]
    Free and Cued Selective Recall Test (FCSRT) score

  4. cognitive domain - language [ Time Frame: change from baseline after 12 months (aMCI/AD subjects) ]
    Fluency score

  5. cognitive domain - frontal executive functions [ Time Frame: change from baseline after 12 months ]
    Trail Making Test (TMT) score

  6. quality of life [ Time Frame: change from baseline after 12 months ]
    Dementia Quality of Life (D-QoL) Instrument

  7. coping strategies [ Time Frame: change from baseline after 12 months ]
    Coping Orientation for Problems Experienced - Brief Version (Brief COPE)

  8. caregiver quality of life [ Time Frame: change from baseline after 8 weeks and after 12 months ]
    Psychological Well-Being (PWB) scale

  9. caregiver coping strategies [ Time Frame: change from baseline after 8 weeks and after 12 months ]
    Coping Orientation for Problems Experienced - Brief Version (Brief COPE)

  10. caregiver burden [ Time Frame: change from baseline after 8 weeks and after 12 months ]
    Caregiver Burden Inventory (CBI)

  11. caregiver affect [ Time Frame: change from baseline after 8 weeks and after 12 months ]
    Positive and Negative Affect Schedule (PANAS)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 85 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Fondazione Don Carlo Gnocchi Onlus
ClinicalTrials.gov Identifier: NCT02746484    
Other Study ID Numbers: FdG_AD_02
First Posted: April 21, 2016    Key Record Dates
Last Update Posted: January 18, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Alzheimer Disease
Cognitive Dysfunction
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders