- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07560696
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
Status
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Vinoth Sankar
- Phone Number: +044 0151 706 2000
- Email: Vinoth.Sankar@liverpoolft.nhs.uk
Study Locations
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Liverpool, United Kingdom, L7 8XP
- Recruiting
- Liverpool University Hospitals NHS Foundation Trust
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Contact:
- Matthew Noonan
- Phone Number: +044 0151 706 3734
- Email: Matthew.noonan@liverpoolft.nhs.uk
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Contact:
- Heather Rogers
- Phone Number: +044 0151 706 3702
- Email: heather.rogers@liverpoolft.nhs.uk
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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.
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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.
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Total number of completed sessions per patient on the cognishine platform
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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.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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)
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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.
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)
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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.
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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.
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12 month into the study.
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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.
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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.
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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.
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Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Matthew Noonan, Liverpool University Hospitals NHS Foundation Trust
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LHS0204
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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