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.

Study Overview

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the feasibility of using the Cognishine web-based platform in a large NHS Trust in acute care setting.
Time Frame: 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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess staff and patient experience of using the Cognishine platform during therapy sessions.
Time Frame: 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
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Matthew Noonan, Liverpool University Hospitals NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 3, 2024

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

January 7, 2026

First Submitted That Met QC Criteria

April 28, 2026

First Posted (Actual)

May 1, 2026

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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