Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Feasibility of Web-based Therapy Sessions (Cognishine)

A Feasibility Study to Explore Rehabilitation Outcomes, Usability and User Experience of a Web-Based Platform for Delivering Treatment for Cognitive and Language Impairment Amongst Adults With Acquired Neurological Disorders

The goal of this feasibility study is to explore rehabilitation outcomes, usability and user experience of a web-based platform for delivering treatment for cognitive and language impairment amongst adults with acquired neurological disorders in critical illness and stroke disorders.

The main question it aims to answer is:

" Is it feasible to use a web-based platform for delivering rehabilitation treatment in a large acute National Health Care Organisation"

Participants will undergo therapy sessions prescribed by therapists on a web-based platform instead of the conventional paper-based therapy sessions for their cognitive and speech rehabilitation needs.

Studie Overzicht

Gedetailleerde beschrijving

The population group will be adult patients admitted to critical care unit and stroke unit and diagnosed to have speech and cognitive impairment.

The intervention is to provide therapy prescribed by therapist through Cognishine, a web-based platform instead of paper-based therapy session.

The primary objective is to assess feasibility of using the Cognishine web-based platform in a large NHS Trust in acute care setting measured by number of completed therapy sessions, per patient days.

Studietype

Ingrijpend

Inschrijving (Geschat)

80

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

  • Patients with cognitive impairment and/or speech impairment being treated at the LUHFT Intensive Care Units and the Stroke wards
  • Need for Cognitive and/or speech and Language rehabilitation

Exclusion Criteria:

  • Inability to obtain consent
  • Refusal to take part in the study
  • Failure to engage with the Cognishine platform
  • Inability to operate a mobile device/ tablet with support
  • Unavailability of study therapist to provide training of patients
  • Unstable medical condition

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ander
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Web-based patient-led therapy sessions
All patients will receive standard of care rehabilitation. In addition, patients recruited into the study will use the Cognishine platform for cognitive and/or language rehabilitation
The Cognishine platform is a digital (web-based) general health and wellness monitoring platform. It is designed to support health care professionals specialised in rehabilitation of patients with neurological disorders, through a wide range of multi-media based generalised activities across speech, language, social-emotional, and cognition.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
To assess the feasibility of using the Cognishine web-based platform in a large NHS Trust in acute care setting.
Tijdsspanne: From recruitment until discharge from rehabilitation therapy or discharge from hospital, which ever comes first. Time frames will vary dependent on patient recovery .The anticipated time frame is 1 to 6 months. Maximum follow up is 12 months.
Total number of completed sessions per patient on the cognishine platform
From recruitment until discharge from rehabilitation therapy or discharge from hospital, which ever comes first. Time frames will vary dependent on patient recovery .The anticipated time frame is 1 to 6 months. Maximum follow up is 12 months.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
To assess staff and patient experience of using the Cognishine platform during therapy sessions.
Tijdsspanne: Patients will be asked to complete this on discharge from hospital. Therapists will be asked to complete the questionnaire one month after starting the study (in the middle of recruitment)

Patients & therapists will be asked to complete the Mobile Health App Usability Questionnaire (MAUQ)for Interactive Mobile Health Apps used by patients.

The questionnaire is designed and validated to evaluate the usability of interactive health apps from the users perspective.

The MAUQ questionnaire comprises of 21 questions which cover 3 main usability domains.

  1. Ease of use-Navigation, learnability and clarity.
  2. Interface and satisfaction-Visual appeal, confidence and overall satisfaction.
  3. Usefulness-Perceived value and effectiveness in helping users achieve their health goals.

Scoring is via a 7 point Likert scale (1 - strongly disagree, 2 - disagree, 3 - somewhat disagree, 4 - neither agree nor disagree, 5 - somewhat agree, 6 -agree, 7 - strongly agree.),with higher scores indicating greater usability and satisfaction.

Patients will be asked to complete this on discharge from hospital. Therapists will be asked to complete the questionnaire one month after starting the study (in the middle of recruitment)
To generate qualitative data about how to improve the end user experience for therapist to target barriers to implementation
Tijdsspanne: 12 month into the study.
Focus groups composed of therapists who have used the platform will be asked to provide end user information about using the system. This qualitative data will be used to improve the platform.
12 month into the study.
To generate preliminary data on the rehabilitation progress associated with the use of the Cognishine platform.
Tijdsspanne: As recovery is highly individualised time frames will vary amongst participants .It is anticipated that the time frame will range from 1 to 6 months.

The Montreal Cognitive Assessment (MoCA) is a standard clinical measurement tool.

The tool comprises assessment of visuospatial/executive functions ,naming, memory, attention, language ,abstraction and orientation.

The scoring range is 0-30,with higher scores indicating better cognition, scores of <26 indicating possible cognitive impairment.

Scores will be collected from clinical notes at initial assessment and at discharge from rehabilitation therapy.

As recovery is highly individualised time frames will vary amongst participants .It is anticipated that the time frame will range from 1 to 6 months.
To generate preliminary data on the rehabilitation progress associated with the use of the Cognishine platform.
Tijdsspanne: As recovery is highly individualised time frames will vary amongst participants .It is anticipated that the time frame will range from 1 to 6 months

The Oxford Cognitive Screen(OCS) is specifically for stroke patients and reduces visual or language bias. It assesses attention, executive function, memory, language, number processing and praxis.

Each domain is scored with results interpreted as impaired or not impaired. Scores from clinical notes will be collected at initial assessment and at discharge from rehabilitation therapy.

As recovery is highly individualised time frames will vary amongst participants .It is anticipated that the time frame will range from 1 to 6 months
To generate preliminary data on the rehabilitation progress associated with the use of the Cognishine platform.
Tijdsspanne: As recovery is highly individualised time frames will vary amongst participants .It is anticipated that the time frame will range from 1 to 6 months.

The Orientation log(O-Log) score measures orientation, time place and situation.

10 items are measured , with each item scoring 0-3.The scoring range is 0-30,with higher scores reflecting better function. Scores <25 indicate disorientation.

Scores will be collected at initial assessment and at discharge from rehabilitation therapy

As recovery is highly individualised time frames will vary amongst participants .It is anticipated that the time frame will range from 1 to 6 months.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Studie stoel: Matthew Noonan, Liverpool University Hospitals NHS Foundation Trust

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

3 juli 2024

Primaire voltooiing (Geschat)

1 juli 2026

Studie voltooiing (Geschat)

1 juli 2026

Studieregistratiedata

Eerst ingediend

7 januari 2026

Eerst ingediend dat voldeed aan de QC-criteria

28 april 2026

Eerst geplaatst (Werkelijk)

1 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

1 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

28 april 2026

Laatst geverifieerd

1 februari 2026

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren