Denne side blev automatisk oversat, og nøjagtigheden af oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

16. januar 2017 opdateret af: 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

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

Fase

Ikke anvendelig

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

65 år til 85 år (Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Behandling
Tildeling: Randomiseret
Interventionel model: Parallel tildeling
Maskning: Enkelt

Antal våben

Våben og indgreb

Deltagergruppe / Arm	Intervention / Behandling
Eksperimentel: Ability platform program Multi-domain at home rehabilitation program delivered through the Ability platform.	Andet: 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).
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)	Andet: Usual care program Usual care at home program (paper and pencil cognitive activities; promotion of physical activity according to healthcare professional's advice)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
activities of daily living Tidsramme: 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 Tidsramme: 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) Tidsramme: 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) Tidsramme: 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) Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: change from baseline after 12 months (aMCI/AD subjects)	Montreal Cognitive Asssessment (MoCA) score	change from baseline after 12 months (aMCI/AD subjects)

Sekundære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
activities of daily living Tidsramme: 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 Tidsramme: change from baseline after 12 months (aMCI subjects)	conversion rate score	change from baseline after 12 months (aMCI subjects)
cognitive domain - long term memory Tidsramme: 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 Tidsramme: 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 Tidsramme: change from baseline after 12 months	Trail Making Test (TMT) score	change from baseline after 12 months
quality of life Tidsramme: change from baseline after 12 months	Dementia Quality of Life (D-QoL) Instrument	change from baseline after 12 months
coping strategies Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Fondazione Don Carlo Gnocchi Onlus

Samarbejdspartnere

University of Milano Bicocca

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. april 2015

Primær færdiggørelse (Faktiske)

1. oktober 2016

Studieafslutning (Faktiske)

1. oktober 2016

Datoer for studieregistrering

Først indsendt

12. april 2016

Først indsendt, der opfyldte QC-kriterier

20. april 2016

Først opslået (Skøn)

21. april 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

18. januar 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. januar 2017

Sidst verificeret

1. januar 2017

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

FdG_AD_02

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Demens

ACADIA Pharmaceuticals Inc.

Rekruttering

Fase 2, effektivitet og sikkerhedsundersøgelse af ACP-204 i Lewy Body Dementia Psychosis

Lewy Body Dementia Psychosis

Forenede Stater, Tjekkiet, Serbien, Frankrig, Bulgarien, Italien
ACADIA Pharmaceuticals Inc.

Tilmelding efter invitation

Fase 3, åben etiketudvidelsesundersøgelse af ACP-204 i Lewy Body Dementia Psychosis

Lewy Body Dementia Psychosis

Forenede Stater, Tjekkiet, Bulgarien

Kliniske forsøg med Ability platform program

The University of Queensland
Restorative Outcomes Australia; Department of Education, Queensland; Queensland... og andre samarbejdspartnere

Ukendt

Test af effektiviteten af Ability School Engagement Partnership Program (ASEP) (ASEP)

Antisocial adfærd | Skolegang | Velfærdsafhængighed

Australien
Massachusetts General Hospital
National Institute on Aging (NIA)

Aktiv, ikke rekrutterende

Sunde aktiviteter forbedrer liv (HAIL) (HAIL)

Fysisk aktivitet

Forenede Stater
Ufuk University

Ukendt

Star Excursion Balance for Patellofemoral Pain Syndrome (SEBT)

Patellofemoralt smertesyndrom

Kalkun
University of Huddersfield

Afsluttet

Styrkebaseret behandlingsmetode for voksne med ADHD

Attention Deficit Hyperactivity Disorder

Det Forenede Kongerige
Universidade Federal de Pernambuco

Ukendt

Effektiviteten af et helkropsvibrationstræningsprogram hos voksne nyretransplanterede patienter

Dyrke motion | Nyretransplantation

Brasilien
Stanford University
University of Michigan

Ikke rekrutterer endnu

Det Forebyggende Risikoudbud Og Kaskadetestning (PROACT)

Genetisk disposition | Familie medlemmer
Defence Primary Health Care, UK
University of Birmingham

Aktiv, ikke rekrutterende

Overlevelses- og succesrater for tandimplantater med ekstern og intern forbindelse anbragt i det britiske væbnede styrker.

Tandtab | Tandimplantat mislykkedes | Implantatkomplikation

Det Forenede Kongerige
University of California, Los Angeles
National Institute on Aging (NIA); BioSensics

Aktiv, ikke rekrutterende

Fjernspilbaseret træningsprogram for kognitiv og motorisk funktionsforbedring

Kognitiv svækkelse | Demens | Mild kognitiv svækkelse | Hukommelsestab

Forenede Stater
Aristotle University Of Thessaloniki
Region Stockholm; Hospital Universitario La Fe; University of Glasgow

Afsluttet

Real-Life Pilot Feasibility Study (LC_RLP_PUC1) (LC_RLP)

Brystkræft | Prostatakræft

Grækenland
Universidade Estadual do Norte do Parana
Conselho Nacional de Desenvolvimento Científico e Tecnológico

Afsluttet

Virkninger af helkropsvibrationer i forskellige enheder på knogle- og muskelmasse hos postmenopausale kvinder

Livskvalitet | Fysisk funktionel ydeevne | Knogletæthed | Utilsigtet fald | Muskler

Brasilien

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