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Feasibility of Web-based Therapy Sessions (Cognishine)

28 de abril de 2026 actualizado por: Liverpool University Hospitals NHS Foundation Trust

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.

Descripción general del estudio

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

80

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Otro
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
To assess the feasibility of using the Cognishine web-based platform in a large NHS Trust in acute care setting.
Periodo de tiempo: 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.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
To assess staff and patient experience of using the Cognishine platform during therapy sessions.
Periodo de tiempo: 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
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Silla de estudio: Matthew Noonan, Liverpool University Hospitals NHS Foundation Trust

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

3 de julio de 2024

Finalización primaria (Estimado)

1 de julio de 2026

Finalización del estudio (Estimado)

1 de julio de 2026

Fechas de registro del estudio

Enviado por primera vez

7 de enero de 2026

Primero enviado que cumplió con los criterios de control de calidad

28 de abril de 2026

Publicado por primera vez (Actual)

1 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

1 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

28 de abril de 2026

Última verificación

1 de febrero de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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