- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07826975
Assessment of Changes in Autonomy Through Analysis of Smartphone Usage Data in Patients With Alzheimer's Disease (AUMASMART)
Alzheimer's disease is the leading cause of dementia worldwide. The first cognitive function to be affected is memory. As the disease progresses, other cognitive systems are affected, leading to a gradual loss of independence for the patient. This loss of independence is at the heart of the psychosocial and medico-economic challenges posed by Alzheimer's disease. Functional independence refers to the patient's ability to perform activities of daily living. The evolution of autonomy varies significantly from one individual to another, and a specific, personalized assessment is necessary in order to offer appropriate care and services. There is a link between patient autonomy and psycho-behavioral disorders. Early identification of loss of autonomy in connection with psycho-behavioral disorders would allow specific treatment to be put in place.
The study hypothesis is that there is a link between changes in smartphone data and changes in the independence of patients with AD.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Adrien JULIAN, MD
- Telefonnummer: +33 05.49.44.44.44
- E-post: adrien.julian@chu-poitiers.fr
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Age ≥ 60 years
- Patient consulting on routine care at a memory resource and research center for Alzheimer's disease defined by cognitive memory complaints from the patient or their family and friends, evidence of impaired verbal episodic memory storage in FCSRT defined by a sum of FR values less than 17/48 and a sum of CR values less than 40/48 compared to the patient's age and socio-cultural level and no criteria on other neuropsychological tests, progressive decline over at least 6 months affecting independence, and if a brain MRI, a lumbar puncture, and/or an 18FDG PET scan were performed as part of the patient's routine care, the results must be consistent with a diagnosis of MA.
- Patient with a smartphone for their exclusive use that is compatible with the installation of the IMASMART application on Android
- No sensory impairment (vision or hearing impairment) that could compromise the use of a smartphone
- Absence of major anxiety-depressive disorder defined by a HAD score > 16
- Patient an caregiver not objecting to participating in the study
Exclusion Criteria:
- Inability to perform the Mini-Mental State Examination or score < 17
- Other neurodegenerative disorders
- Severe, unstable psychiatric disorders
- Terminal phase of a severe illness
- Other conditions that may compromise the use of a smartphone
- Patients with an iPhone
- MRI evidence of a lesion that may contribute to cognitive impairment (stroke, tumors, etc.)
- Refusal to install the application
- People residing in a residential care for senior or any other medical facility
- Individuals benefiting from enhanced protection, namely individuals deprived of their liberty by judicial or administrative decision, adults under legal protection, and finally, patients in emergency situations.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Pasienter med Alzheimers
|
Collection of Android smartphone usage
MMSE, FCSRT, FAB, TMT, verbal fluency test, Rey figure, BBEP, langage assesments and HAD scale
IADL Amsterdam assessed by the caregiver
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Comparison of changes in smartphone usage data and battery life collected at 0 and 18 months
Tidsramme: From enrollment to the end of participation at 18 months
|
To measure the relationship between variations in smartphone usage data-represented as a single parameter created through a mathematical combination-and variations in the Amsterdam IADL questionnaire between 0 and 18 months.
|
From enrollment to the end of participation at 18 months
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studiestol: Céline ABONNEAU, Poitiers University Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Hjernesykdommer
- Sykdommer i sentralnervesystemet
- Sykdommer i nervesystemet
- Psykiske lidelser
- Nevrokognitive lidelser
- Demens
- Tauopatier
- Nevrodegenerative sykdommer
- Alzheimers sykdom
- Helsevesenets kvalitet, tilgang og evaluering
- Undersøkelsesteknikker
- Epidemiologiske metoder
- Helsevesenets evalueringsmekanismer
- Kvalitet på helsehjelpen
- Folkehelse
- Miljø og folkehelse
- Datainnsamling
Andre studie-ID-numre
- 2025-A01157-42
Plan for individuelle deltakerdata (IPD)
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Legemiddel- og utstyrsinformasjon, studiedokumenter
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