- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05476302
Effect of Remote Cognitive Intervention in Patients With Parkinson's Disease During the COVID-19 Pandemic (TELEPARK)
26. juli 2022 opdateret af: Istituto Nazionale di Ricovero e Cura per Anziani
Retrospective study to evaluate the effect of a remote cognitive-rehabilitative intervention during the Covid outbreak in subjects with Parkinson's disease.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Mild cognitive impairment is frequent among people with Parkinson's disease.
Cognitive training seems effective on cognitive status and for mitigating anxiety and depression.
With COVID-19 outbreak, such therapeutic interventions were delivered online.
This retrospective study was aimed at evaluating the effectiveness of an online cognitive treatment, carried out in COVID times and based on the Parkinson's-Adapted Cognitive Stimulation Therapy, on cognitive domains and mood in 18 older people with Parkinson's disease.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
18
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
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Ancona, Italien, 60127
- IRCCS INRCA Hospital
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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
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Patients with Parkinson's disease that, after eight months of COVID-19 lockdown when all interventions were suspended, received an intensive digital cognitive rehabilitation treatment.
Beskrivelse
Inclusion Criteria:
- Parkinson disease: Hoehn & Yahr's scale: 1-3 based on the UK PD Society Brain Bank
- mild cognitive impairment
- no cognitive training between March and October 2020
- presence of a family caregiver to access and use the online platform
Exclusion Criteria:
- other neurological diseases
- deep brain stimulation
- schizophrenia
- depression
- sensory deprivations that could interfere with the treatment
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
---|---|
Cognitive digital treatment
Cognitive digital treatment in patients with Parkinson's disease
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The remote cognitive-rehabilitation treatment was based on Parkinson's adapted cognitive stimulation therapy (CST).
Fourteen twice-weekly sessions were planned, followed by one session per week for a duration of six months for maintenance therapy.
The treatment took place in groups of 4 patients in remote mode through the Microsoft-Teams platform.
All subjects maintained the prescribed drug therapy and regular physiotherapy activity during the intervention.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
changes in cognitive status
Tidsramme: This evaluation was performed in the pre-COVID-19 period, at the beginning of the remote treatment (8 months from the pre-COVID evaluation), and at the end of the remote treatment (7 weeks from the start of the treatment)
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The Mini Mental State Examination (MMSE) was used to evaluate the cognitive status.The test consists of 2 parts: language (time orientation, registration and attention) and performance (recall, response to written/verbal commands, sriting ability and reproduction of complex polygons); the total score can range from 0 to 30, with a higher score indicating better function.
|
This evaluation was performed in the pre-COVID-19 period, at the beginning of the remote treatment (8 months from the pre-COVID evaluation), and at the end of the remote treatment (7 weeks from the start of the treatment)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
changes in cognitive domains
Tidsramme: This evaluation was performed in the pre-COVID-19 period, at the beginning of the remote treatment (8 months from the pre-COVID evaluation), and at the end of the remote treatment (7 weeks from the start of the treatment)
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The Addembrooke's Cognitive Examination Battery (ACE-R) was used to evaluate the cognitive domains.
The ACE-R consists of six components evaluating separate cognitive domains.
A maximum score of 100 is weighted as follows: orientation (10), attention (8), memory(35), verbal fluency (14), language (28), and visuospatialability (5).
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This evaluation was performed in the pre-COVID-19 period, at the beginning of the remote treatment (8 months from the pre-COVID evaluation), and at the end of the remote treatment (7 weeks from the start of the treatment)
|
changes in thymic state
Tidsramme: This evaluation was performed in the pre-COVID-19 period, at the beginning of the remote treatment (8 months from the pre-COVID evaluation), and at the end of the remote treatment (7 weeks from the start of the treatment)
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The Geriatric Depression Scale-15 items (GDS-15 items) was used to evaluate the tymic state.This instrument evaluated depressive symptoms using yes/no answers.
Scores range between 0 and 15 points.
Higher scores indicate more severe depressive symptoms.
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This evaluation was performed in the pre-COVID-19 period, at the beginning of the remote treatment (8 months from the pre-COVID evaluation), and at the end of the remote treatment (7 weeks from the start of the treatment)
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
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 (Faktiske)
1. januar 2020
Primær færdiggørelse (Faktiske)
31. oktober 2020
Studieafslutning (Faktiske)
31. oktober 2020
Datoer for studieregistrering
Først indsendt
22. juli 2022
Først indsendt, der opfyldte QC-kriterier
26. juli 2022
Først opslået (Faktiske)
27. juli 2022
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
27. juli 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
26. juli 2022
Sidst verificeret
1. juli 2022
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Psykiske lidelser
- Hjernesygdomme
- Sygdomme i centralnervesystemet
- Sygdomme i nervesystemet
- Coronavirus infektioner
- Coronaviridae infektioner
- Nidovirales infektioner
- RNA-virusinfektioner
- Virussygdomme
- Infektioner
- Luftvejsinfektioner
- Luftvejssygdomme
- Lungebetændelse, viral
- Lungebetændelse
- Lungesygdomme
- Neurokognitive lidelser
- Parkinsonlidelser
- Basal Ganglia Sygdomme
- Bevægelsesforstyrrelser
- Synukleinopatier
- Neurodegenerative sygdomme
- Kognitionsforstyrrelser
- COVID-19
- Parkinsons sygdom
- Kognitiv dysfunktion
Andre undersøgelses-id-numre
- INRCA_004_2022
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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