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| ID | Type | Description | Link |
|---|---|---|---|
| 23/PR/0917 | Other Identifier | London - Harrow Research Ethics Committee |
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Within the UK there are over 15 million people who live with at least one long term condition. Of these people, over 4 million suffer from mental health problems.
Environmental control systems are a type of assistive technology that can be controlled by a wide variety of different access methods (e.g. switches) and can assist people with physical disabilities usually with a neurological condition to control various electronic devices in the home environment. The systems are designed to provide independence, removing the requirement to be reliant on other people (for the operation of the controlled devices) and potentially could have a positive effect on mental health and quality of life.
The research question for this study is to determine impact of environmental controls on mental health. It is hypothesised that there will be a positive impact on mental health of the participants. The question above will be answered by collecting questionnaire data pre and post intervention. Participants will be identified by Clinical Scientists working in NHS Lothian's Environmental Control Service (ECS). Participants will be recruited from NHS Lothian and so will be living in the Lothian area. The patient will be contacted following the normal protocol for arranging an environmental control assessment, at which point they will be approached to join the study. Participants will answer questions in their home environment both in person and over the phone.
The end point of the study will be 14 months from the start date (allowing for follow up data to be collected for anyone recruited towards the end of the 12-month recruitment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Environmental control system users | Patients who are eligible for environmental control system users as part of standard clinical care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Provision of an environmental control system | Device | Part of standard clinical care for patients referred to the NHS Lothian environmental control service. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving MCID in PROMIS Global10 Score. | Percentage of participants who achieved the minimum clinically important difference (MCID) in the PROMIS-10 Mental Health score from baseline to post-intervention. The MCID for this measure was defined as an improvement of ≥6 points on the PROMIS-10 Mental Health T-score. All scoring was performed according to standard PROMIS guidelines. All participants included in the analysis met the MCID threshold for this outcome. Therefore, the number of participants achieving MCID is equal to the number analysed. These values represent actual measured data and are not placeholders. | From baseline to 8 weeks post installation of the environmental control system. |
| Percentage of Participants Achieving MCID in the PIADS. | The Psychosocial Impact of Assistive Devices Scale (PIADS) is a self-report questionnaire measuring the perceived impact of assistive technology on psychological well-being, functional independence, and quality of life. The outcome measure was the percentage of participants who achieved the minimum clinically important difference (MCID) in the PIADS total score from baseline to post-intervention. The MCID was defined as an improvement of ≥0.5 points on the PIADS scale. Scoring was conducted according to standard PIADS procedures. | From baseline to 8 weeks post installation of the environmental control system. |
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Inclusion Criteria:
Exclusion Criteria:
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NHS Lothian patients who have been referred to the Environmental Control Service and are eligible for environmental controls.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SMART Centre | Edinburgh | EH9 2HL | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29703090 | Background | Vessoyan K, Steckle G, Easton B, Nichols M, Mok Siu V, McDougall J. Using eye-tracking technology for communication in Rett syndrome: perceptions of impact. Augment Altern Commun. 2018 Sep;34(3):230-241. doi: 10.1080/07434618.2018.1462848. Epub 2018 Apr 27. | |
| 34247326 | Background | Terwee CB, Peipert JD, Chapman R, Lai JS, Terluin B, Cella D, Griffiths P, Mokkink LB. Minimal important change (MIC): a conceptual clarification and systematic review of MIC estimates of PROMIS measures. Qual Life Res. 2021 Oct;30(10):2729-2754. doi: 10.1007/s11136-021-02925-y. Epub 2021 Jul 10. |
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IPD is not required to be shared.
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Participants were identified by clinicians working in NHS Lothian's Environmental Control Service. This consisted of screening any new referrals coming into the service and seeing whether they met the inclusion criteria. Recruitment start date: 29/01/2024 and end date: 29/10/2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | Environmental Control System Users | Patients who are eligible for environmental control system users as part of standard clinical care. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Environmental Control System Users | Patients who are eligible for environmental control system users as part of standard clinical care. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Percentage of Participants Achieving MCID in PROMIS Global10 Score. | Percentage of participants who achieved the minimum clinically important difference (MCID) in the PROMIS-10 Mental Health score from baseline to post-intervention. The MCID for this measure was defined as an improvement of ≥6 points on the PROMIS-10 Mental Health T-score. All scoring was performed according to standard PROMIS guidelines. All participants included in the analysis met the MCID threshold for this outcome. Therefore, the number of participants achieving MCID is equal to the number analysed. These values represent actual measured data and are not placeholders. | Posted | Count of Participants | Participants | From baseline to 8 weeks post installation of the environmental control system. |
|
From enrollment until the end of follow up, up to 8 weeks post intervention.
No differences.
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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 | Environmental Control System Users | Patients who are eligible for environmental control system users as part of standard clinical care. |
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The sample size and demographic characteristics may limit generalisability. All outcome analyses are reported in the corresponding results tables.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Graham Henderson | NHS Lothian | +441315379422 | 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 | Oct 24, 2023 | Mar 20, 2026 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
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| 42400500 | Derived | Henderson G, Harris H, Dolan MJ, Hill R. How do environmental control systems affect mental health and psychological well-being? A pilot study. Disabil Rehabil Assist Technol. 2026 Jul 4:1-10. doi: 10.1080/17483107.2026.2697427. Online ahead of print. |
| Years |
|
| 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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| Primary | Percentage of Participants Achieving MCID in the PIADS. | The Psychosocial Impact of Assistive Devices Scale (PIADS) is a self-report questionnaire measuring the perceived impact of assistive technology on psychological well-being, functional independence, and quality of life. The outcome measure was the percentage of participants who achieved the minimum clinically important difference (MCID) in the PIADS total score from baseline to post-intervention. The MCID was defined as an improvement of ≥0.5 points on the PIADS scale. Scoring was conducted according to standard PIADS procedures. | Posted | Count of Participants | Participants | From baseline to 8 weeks post installation of the environmental control system. |
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| 5 |
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| 5 |
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