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Completed

NCT Number: NCT02746484

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

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

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ability platform program

Other

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

Other

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

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Fondazione Don Carlo Gnocchi ETS

Other

Collaborators

  • University of Milano Bicocca

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 21, 2016
Registry last updated
Jan 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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