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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.

Studienübersicht

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

80

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Sonstiges
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
To assess the feasibility of using the Cognishine web-based platform in a large NHS Trust in acute care setting.
Zeitfenster: 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.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
To assess staff and patient experience of using the Cognishine platform during therapy sessions.
Zeitfenster: 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
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

  • Studienstuhl: Matthew Noonan, Liverpool University Hospitals NHS Foundation Trust

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

3. Juli 2024

Primärer Abschluss (Geschätzt)

1. Juli 2026

Studienabschluss (Geschätzt)

1. Juli 2026

Studienanmeldedaten

Zuerst eingereicht

7. Januar 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

28. April 2026

Zuerst gepostet (Tatsächlich)

1. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

1. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

28. April 2026

Zuletzt verifiziert

1. Februar 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Plan für individuelle Teilnehmerdaten (IPD)

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Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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