ABILITY - TelerehABILITation: TechnologY-enhanced Multi-domain at Home Continuum of Care Program
16 januari 2017 uppdaterad av: Fondazione Don Carlo Gnocchi Onlus
ABILITY - TelerehABILITation. TechnologY-enhanced Multi-domain at Home Continuum of Care Program for People With Cognitive Impairment.
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
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
30
Fas
- Inte tillämpbar
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
65 år till 85 år (Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Ability platform program
Multi-domain at home rehabilitation program delivered through the Ability platform.
|
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).
|
|
Aktiv komparator: Usual care program
Usual care at home program (paper and pencil cognitive activities; promotion of physical activity according to healthcare professional's advice)
|
Usual care at home program (paper and pencil cognitive activities; promotion of physical activity according to healthcare professional's advice)
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
activities of daily living
Tidsram: change from baseline after 8 weeks (aMCI/AD subjects)
|
Activities of Daily Living Inventory (ADCS/ADL)
|
change from baseline after 8 weeks (aMCI/AD subjects)
|
|
behavioral symptoms
Tidsram: change from baseline after 8 weeks (aMCI/AD subjects)
|
Neuropsychiatric Inventory (NPI) score
|
change from baseline after 8 weeks (aMCI/AD subjects)
|
|
cognitive domain (long-term memory)
Tidsram: change from baseline after 8 weeks (aMCI/AD subjects)
|
Free and Cued Selective Recall Test (FCSRT) score
|
change from baseline after 8 weeks (aMCI/AD subjects)
|
|
cognitive domain (language)
Tidsram: change from baseline after 8 weeks (aMCI/AD subjects)
|
Fluency score
|
change from baseline after 8 weeks (aMCI/AD subjects)
|
|
cognitive domain (frontal-executive functions)
Tidsram: change from baseline after 8 weeks (aMCI/AD subjects)
|
Trail Making Test (TMT) score
|
change from baseline after 8 weeks (aMCI/AD subjects)
|
|
quality of life
Tidsram: change from baseline after 8 weeks (aMCI/AD subjects)
|
Dementia Quality of Life (D-QoL) Instrument
|
change from baseline after 8 weeks (aMCI/AD subjects)
|
|
coping strategies
Tidsram: change from baseline after 8 weeks (aMCI/AD subjects)
|
Coping Orientation for Problems Experienced - Brief Version (Brief COPE)
|
change from baseline after 8 weeks (aMCI/AD subjects)
|
|
global cognitive level
Tidsram: change from baseline after 12 months (aMCI/AD subjects)
|
Montreal Cognitive Asssessment (MoCA) score
|
change from baseline after 12 months (aMCI/AD subjects)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
activities of daily living
Tidsram: change from baseline after 12 months (aMCI/AD subjects)
|
Activities of Daily Living Inventory (ADCS/ADL)
|
change from baseline after 12 months (aMCI/AD subjects)
|
|
conversion rate MCI versus AD
Tidsram: change from baseline after 12 months (aMCI subjects)
|
conversion rate score
|
change from baseline after 12 months (aMCI subjects)
|
|
cognitive domain - long term memory
Tidsram: change from baseline after 12 months (aMCI/AD subjects)
|
Free and Cued Selective Recall Test (FCSRT) score
|
change from baseline after 12 months (aMCI/AD subjects)
|
|
cognitive domain - language
Tidsram: change from baseline after 12 months (aMCI/AD subjects)
|
Fluency score
|
change from baseline after 12 months (aMCI/AD subjects)
|
|
cognitive domain - frontal executive functions
Tidsram: change from baseline after 12 months
|
Trail Making Test (TMT) score
|
change from baseline after 12 months
|
|
quality of life
Tidsram: change from baseline after 12 months
|
Dementia Quality of Life (D-QoL) Instrument
|
change from baseline after 12 months
|
|
coping strategies
Tidsram: change from baseline after 12 months
|
Coping Orientation for Problems Experienced - Brief Version (Brief COPE)
|
change from baseline after 12 months
|
|
caregiver quality of life
Tidsram: change from baseline after 8 weeks and after 12 months
|
Psychological Well-Being (PWB) scale
|
change from baseline after 8 weeks and after 12 months
|
|
caregiver coping strategies
Tidsram: change from baseline after 8 weeks and after 12 months
|
Coping Orientation for Problems Experienced - Brief Version (Brief COPE)
|
change from baseline after 8 weeks and after 12 months
|
|
caregiver burden
Tidsram: change from baseline after 8 weeks and after 12 months
|
Caregiver Burden Inventory (CBI)
|
change from baseline after 8 weeks and after 12 months
|
|
caregiver affect
Tidsram: change from baseline after 8 weeks and after 12 months
|
Positive and Negative Affect Schedule (PANAS)
|
change from baseline after 8 weeks and after 12 months
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 april 2015
Primärt slutförande (Faktisk)
1 oktober 2016
Avslutad studie (Faktisk)
1 oktober 2016
Studieregistreringsdatum
Först inskickad
12 april 2016
Först inskickad som uppfyllde QC-kriterierna
20 april 2016
Första postat (Uppskatta)
21 april 2016
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
18 januari 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
16 januari 2017
Senast verifierad
1 januari 2017
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- FdG_AD_02
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .