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Effect of Remote Cognitive Intervention in Patients With Parkinson's Disease During the COVID-19 Pandemic (TELEPARK)

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

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

      • Ancona, Italien, 60127
        • IRCCS INRCA Hospital

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
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.

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)
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)

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)
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).
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)
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.
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)

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

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 COVID-19

Kliniske forsøg med Cognitive digital treatment

3
Abonner