An observational study in Neurologic Disorders, sponsored by NHS Lothian. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-05-05.
Sponsored by NHS Lothian · Observational
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.
757 studies on the registry are indexed under Nervous System Diseases; 218 are open to participants now.
This study's enrollment of 5 is below the median of 150 across 228 observational studies indexed under Nervous System Diseases.
Browse Nervous System Diseases studies →NHS Lothian is the lead sponsor of 53 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
NHS Lothian patients who have been referred to the Environmental Control Service and are eligible for environmental controls.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients who are eligible for environmental control system users as part of standard clinical care.
Device: Provision of an environmental control system
Part of standard clinical care for patients referred to the NHS Lothian environmental control service.
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.
Time frame: 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.
Time frame: From baseline to 8 weeks post installation of the environmental control system.
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.
| Milestone | Environmental Control System Users |
|---|---|
| Started | 5 |
| Completed | 5 |
| Not completed | 0 |
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.
| Participants | Environmental Control System Users |
|---|---|
| Percentage of Participants Achieving MCID in PROMIS Global10 Score. | 5 |
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.
| Participants | Environmental Control System Users |
|---|---|
| Percentage of Participants Achieving MCID in the PIADS. | 4 |
Collected over From enrollment until the end of follow up, up to 8 weeks post intervention.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Environmental Control System Users | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Age, Continuous(Years) | Environmental Control System Users |
|---|---|
| Mean | 60.6 ± 8.2 |
| Sex: Female, Male(Participants) | Environmental Control System Users |
|---|---|
| Female | 3 |
| Male | 2 |
| Race and Ethnicity Not Collected(Participants) | Environmental Control System Users |
|---|
| Region of Enrollment(Participants) | Environmental Control System Users |
|---|---|
| United Kingdom | 5 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — IPD is not required to be shared.
Ran from Jan 2024 to primary completion in May 2025, 15 months.
Results were first posted in Apr 2026, 10 months after primary completion.
Of 97 non-industry observational studies under Nervous System Diseases, half reached primary completion within 55 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 150. This study's 15 months is below that.
Counting every sponsor, half of 114 studies reached it within 53 months; a quarter within 20 and three quarters within 121.
Nervous System Diseases covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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NHS Lothian