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Usability Study of OnTrack Tools

Primary Purpose

Research With Clinical Staff in Stroke Rehabilitation

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
OnTrack Tools
Sponsored by
Imperial College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Research With Clinical Staff in Stroke Rehabilitation focused on measuring stroke, rehabilitation, neurology, digital health

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Imperial College Healthcare NHS Trust

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Therapists

Arm Description

Single arm study. Participants are members of the therapy team at Imperial College Healthcare NHS Trust's stroke wards.

Outcomes

Primary Outcome Measures

System Usability Scale (SUS)
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.

Secondary Outcome Measures

Post-Study System Usability Questionnaire (PSSUQ)
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. The measure is scored on a 0-100 scale, a higher score means a better outcome.
Ease of Use Scale (USE)
USE stands for Usefulness, Satisfaction, and Ease of use. For many applications, Usability appears to consist of Usefulness and Ease of Use, and Usefulness and Ease of Use are correlated. The questionnaire is constructed as seven-point Likert rating scales. Users are asked to rate agreement with the statements, ranging from strongly disagree to strongly agree. The measure is scored on a 0-100 scale, a higher score means a better outcome.

Full Information

First Posted
April 1, 2022
Last Updated
August 3, 2022
Sponsor
Imperial College London
Collaborators
Imperial College Healthcare NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT05330234
Brief Title
Usability Study of OnTrack Tools
Official Title
Usability Study of OnTrack Tools: a Study to Assess the Usability of a Clinician-facing Software Application to Support Arm Rehabilitation After Stroke.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
May 12, 2022 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London
Collaborators
Imperial College Healthcare NHS Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Research With Clinical Staff in Stroke Rehabilitation
Keywords
stroke, rehabilitation, neurology, digital health

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This study aims to assess the usability of the OnTrack Tools GUI under simulation. The study follows up from a study of the OnTrack system that demonstrated the feasibility and acceptability of the patient-facing component of the system by stroke survivors and therapists. The design of this study was developed through a collaborative approach between the study researchers, patients, and front-line therapists. The OnTrack intervention is being developed by Imperial College, this usability study is part of the development process.
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Therapists
Arm Type
Other
Arm Description
Single arm study. Participants are members of the therapy team at Imperial College Healthcare NHS Trust's stroke wards.
Intervention Type
Device
Intervention Name(s)
OnTrack Tools
Intervention Description
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.
Primary Outcome Measure Information:
Title
System Usability Scale (SUS)
Description
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.
Time Frame
Up to 60 days.
Secondary Outcome Measure Information:
Title
Post-Study System Usability Questionnaire (PSSUQ)
Description
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. The measure is scored on a 0-100 scale, a higher score means a better outcome.
Time Frame
Up to 60 days.
Title
Ease of Use Scale (USE)
Description
USE stands for Usefulness, Satisfaction, and Ease of use. For many applications, Usability appears to consist of Usefulness and Ease of Use, and Usefulness and Ease of Use are correlated. The questionnaire is constructed as seven-point Likert rating scales. Users are asked to rate agreement with the statements, ranging from strongly disagree to strongly agree. The measure is scored on a 0-100 scale, a higher score means a better outcome.
Time Frame
Up to 60 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ara Darzi
Organizational Affiliation
Imperial College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Imperial College Healthcare NHS Trust
City
London
ZIP/Postal Code
W2 1NY
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plan for individual participant data to be shared.

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Usability Study of OnTrack Tools

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