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| ID | Type | Description | Link |
|---|---|---|---|
| 24/NW/0057 | Other Identifier | North West - Greater Manchester East Research Ethics Committee |
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Environmental control systems are a type of assistive technology that can be controlled by a wide variety of different methods (e.g. switches) and can assist people with physical disabilities to control various electronic devices in the home. Communication aids are designed to assist people who have difficulties speaking to communicate. Both systems are designed to provide independence and potentially could have a positive effect on quality of life.
The majority of communication aid and environmental control systems aimed at high end users require a screen to be mounted in front of the user. The limitations with this are that the user is only able to access their device when it has been suitably mounted in front of them. There are occasions when mounting devices in front of the user is difficult due to other considerations for example transfers in and out of a wheelchair. As smart glasses can potentially be worn at all times during the day this could provide an effective alternative solution.
The purpose of this study is to explore with service users the usability and satisfaction provided by smart glasses when operating a communication aid/environmental control system. The study will achieve the above aim by undertaking a satisfaction questionnaire prior and post a 3 week trial of using smart glasses with their device. In addition an interview will be carried out with participants to explore the impact that smart glasses has had on the usability of their device.
Participants will be recruited by contacting eligible patients of the NHS Lothian Environmental Control Service and communication aid service. The end point of the study will be 8 months from the start date (allowing for follow up data to be collected for anyone recruited towards the end of the 6-month recruitment period).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Smart glasses | Experimental | The participant will be provided with a set of smart glasses (X-REAL Air 2) as an alternative display for their existing environmental control system. They will have the smart glasses to trial for a period of 3 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Provision of smart glasses for environmental control use | Device | To the authors knowledge there has not been a clinical trial that includes the use of smart glasses with environmental controls. The smart glasses were used with environmental control systems that had a USB-C display output. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quest Device Score From Baseline to Post-intervention | The QUEST 2.0 is a 12-item instrument that measures user satisfaction with assistive technology devices and related services. Each item is scored from 1 to 5, where 1 indicates the lowest satisfaction and 5 indicates the highest satisfaction. The instrument includes 8 device items and 4 service items. In this study, only the 8 device items were administered because the focus was on the assistive technology device itself. The QUEST Device Score was calculated as the mean of the 8 device item scores, producing a possible total score range from 1.0 (lowest satisfaction) to 5.0 (highest satisfaction). The outcome represents the change in QUEST Device Score, defined as the difference between baseline and the score obtained at the end of the 3-week smart-glasses trial. | Baseline to 3 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SMART Centre, Astley Ainslie Hospital | Edinburgh | EH9 2HL | United Kingdom |
Not required. A summary of the data in an anonymised form is sufficient.
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Current environmental control service users of for the NHS Lothian's Environmental Control Service were screened for their eligibility for the study using a pre-defined criteria. Service users who met the requirements and were contacted by telephone to see if they wanted to take part in the study. The recruitment start date was 01/05/2024 and the recruitment end date was 04/07/2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | Smart Glasses | The participant will be provided with a set of smart glasses (X-REAL Air 2) as an alternative display for their existing environmental control system. They will have the smart glasses to trial for a period of 3 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Smart Glasses | The participant will be provided with a set of smart glasses (X-REAL Air 2) as an alternative display for their existing environmental control system. They will have the smart glasses to trial for a period of 3 weeks. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Quest Device Score From Baseline to Post-intervention | The QUEST 2.0 is a 12-item instrument that measures user satisfaction with assistive technology devices and related services. Each item is scored from 1 to 5, where 1 indicates the lowest satisfaction and 5 indicates the highest satisfaction. The instrument includes 8 device items and 4 service items. In this study, only the 8 device items were administered because the focus was on the assistive technology device itself. The QUEST Device Score was calculated as the mean of the 8 device item scores, producing a possible total score range from 1.0 (lowest satisfaction) to 5.0 (highest satisfaction). The outcome represents the change in QUEST Device Score, defined as the difference between baseline and the score obtained at the end of the 3-week smart-glasses trial. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline to 3 weeks |
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From enrollment until end of follow up, up to 8 weeks.
The NHS Lothian Adverse Event Management Policy and Operational Procedure was followed for recording and dealing with adverse incidents.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Smart Glasses | The participant will be provided with a set of smart glasses (X-REAL Air 2) as an alternative display for their existing environmental control system. They will have the smart glasses to trial for a period of 3 weeks. |
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Only four participants took part in this study, which may limit the generalisability of the findings to wider populations or to individuals with other neurological conditions. In addition, the researcher who conducted the interviews was also one of the clinicians involved in providing environmental control services to participants. This may introduce the possibility of response bias. These factors represent limitations of the study design and should be considered when interpreting the results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Graham Henderson | NHS Lothian | 0131 537 9422 | graham.henderson@nhs.scot |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 7, 2024 | Mar 20, 2026 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
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| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | Participants |
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| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
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