- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05330234
Usability Study of OnTrack Tools
Usability Study of OnTrack Tools: a Study to Assess the Usability of a Clinician-facing Software Application to Support Arm Rehabilitation After Stroke.
Aims: Assess the usability of OnTrack Tools, a clinician facing interface to manage stroke survivors using the OnTrack rehabilitation system. Background: Arm disability is a common problem after stroke that can lead to loss of independence, it affects
~450,000 people in the UK. Repetitive activity is critical for recovery but research shows people can struggle with intensity and keeping track of progress. The OnTrack system being developed at Imperial College London is a potential solution to this problem. Intervention: The OnTrack system consists of two software applications, OnTrack App - used by patients, and OnTrack Tools - used by clinicians. OnTrack Tools pulls data generated by the OnTrack App and enables the monitoring of clients' arm activity, and management of goals and educational content. The software is used to inform selfmanagement coaching by helping therapists understand more about how and when patients use their affected arm between treatment sessions. Design and methods: This study will assess the usability of the OnTrack Tools component of the system. The study will recruit stroke therapists from Imperial College Healthcare NHS Trust to provide feedback on the experience and usability of OnTrack Tools' graphical user interface (GUI). The study will be divided into three progressive cycles of testing, feedback and iteration. Each cycle will see participants individually completing specific tasks related to system navigation and the management of patients under simulation. Participants will complete outcome measures and take part in focus groups. Researchers will analyse and use the feedback to improve the GUI ready for the next testing cycle. Patient and public involvement: The project team includes a PPIE group of stroke survivors who oversee the project and help us with public facing documentation. They are members of the research team and are reimbursed for their time and travel, according to INVOLVE guidance. Dissemination: Results of the study will be written-up for technical reporting and publication. Participants will be provided with a summary of results at the end of the study. The study team will be providing general updates on the progress of the study via their social media channels (e.g. Twitter @OnTrackRehab @ImperialIGHI @HelixCentre).
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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London, United Kingdom, W2 1NY
- Imperial College Healthcare NHS Trust
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adult (18 years old or over) Occupational Therapists and Physiotherapists (Band 4 to Band 8) working in the stroke wards at ICHT.
Exclusion Criteria:
- No exclusion criteria has been defined.
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 |
|---|---|
|
Other: Therapists
Single arm study.
Participants are members of the therapy team at Imperial College Healthcare NHS Trust's stroke wards.
|
The intervention is the OnTrack Tools system consisting of a graphical user interface (GUI) used to manage patients who are users of the OnTrack rehabilitation system. Participants will be asked to complete clinical and non-clinical tasks in simulation using OnTrack Tools. The themes for the scenarios of use presented in each of the three phases are summarised below: Phase 1 - Account creation, system onboarding and general system navigation. Phase 2 - Individual patient management. Phase 3 - Content and data management. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
System Usability Scale (Phase 1)
Time Frame: Up to 60 days.
|
In systems engineering, the system usability scale (SUS) is a simple, ten-item attitude Likert scale giving a global view of subjective assessments of usability. It was developed by John Brooke[1] at Digital Equipment Corporation in the UK in 1986 as a tool to be used in usability engineering of electronic office systems. The measure is scored on a 0-100 scale, a higher score means a better outcome. |
Up to 60 days.
|
|
System Usability Scale (Phase 2)
Time Frame: Up to 60 days
|
In systems engineering, the system usability scale (SUS) is a simple, ten-item attitude Likert scale giving a global view of subjective assessments of usability. It was developed by John Brooke[1] at Digital Equipment Corporation in the UK in 1986 as a tool to be used in usability engineering of electronic office systems. The measure is scored on a 0-100 scale, a higher score means a better outcome. |
Up to 60 days
|
|
System Usability Scale (Phase 3)
Time Frame: Up to 60 days.
|
In systems engineering, the system usability scale (SUS) is a simple, ten-item attitude Likert scale giving a global view of subjective assessments of usability. It was developed by John Brooke[1] at Digital Equipment Corporation in the UK in 1986 as a tool to be used in usability engineering of electronic office systems. The measure is scored on a 0-100 scale, a higher score means a better outcome. |
Up to 60 days.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Post-Study System Usability Questionnaire (PSSUQ)
Time Frame: Up to 60 days.
|
The PSSUQ (Post-Study System Usability Questionnaire is a 16-item standardized questionnaire. It is widely used to measure users' perceived satisfaction of a website, software, system or product at the end of a study. PSSUQ follows a 7-point Likert Scale (+ NA option). 1 is "strongly agree" and 7 is "strongly disagree" Results are calculated by averaging the scores from the 7 points of the scale. The PSSUQ has one overall score and 3 sub-scales, namely system usefulness, information quality, and interface quality scored as follows: Overall: the average scores of questions 1 to 16 System Usefulness (SYSUSE): the average scores of questions 1 to 6 Information Quality (INFOQUAL): the average scores of questions 7 to 12 Interface Quality (INTERQUAL): the average scores of questions 13 to 15 The lower the scores, the better the performance and the higher the perceived satisfaction. |
Up to 60 days.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ara Darzi, Imperial College London
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- 22CX7578
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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