- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Vinoth Sankar
- Numéro de téléphone: +044 0151 706 2000
- E-mail: Vinoth.Sankar@liverpoolft.nhs.uk
Lieux d'étude
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Liverpool, Royaume-Uni, L7 8XP
- Recrutement
- Liverpool University Hospitals NHS Foundation Trust
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Contact:
- Matthew Noonan
- Numéro de téléphone: +044 0151 706 3734
- E-mail: Matthew.noonan@liverpoolft.nhs.uk
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Contact:
- Heather Rogers
- Numéro de téléphone: +044 0151 706 3702
- E-mail: heather.rogers@liverpoolft.nhs.uk
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: 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
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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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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To assess the feasibility of using the Cognishine web-based platform in a large NHS Trust in acute care setting.
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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To assess staff and patient experience of using the Cognishine platform during therapy sessions.
Délai: 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
Délai: 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.
Délai: 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.
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To generate preliminary data on the rehabilitation progress associated with the use of the Cognishine platform.
Délai: 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 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
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To generate preliminary data on the rehabilitation progress associated with the use of the Cognishine platform.
Délai: 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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Collaborateurs et enquêteurs
Collaborateurs
Les enquêteurs
- Chaise d'étude: Matthew Noonan, Liverpool University Hospitals NHS Foundation Trust
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- LHS0204
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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