Neurologic DisordersEC-MHNCT07049419
The Impact of Environmental Controls on Mental Health
An observational study of Neurologic Disorders, run by NHS Lothian at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Neurologic Disorders
- Type of treatment
- Medical device
- How many people
- 5 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 Jan 2024to 27 May 2025
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: NHS Lothian patients who have been referred to the Environmental Control Service and are eligible for environmental controls.
Who may be able to join
- Eligible for environmental control system (as per NHS Scotland criteria).
- New user (no previous intervention).
- Neurological condition.
- Cognitive ability to answer the questions and to give consent.
Who cannot join
- Previous environmental control intervention.
- Patients requiring equipment not supplied by NHS Lothian's ECS (e.g. door interface).
- Patient recently diagnosed (within 6 months).
- Rapidly deteriorating condition.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Neurologic Disorders
- Being tested
- Provision of an environmental control system
- Keywords
- Environmental controls, Activities of daily living, Mental health, Self-help devices, Psychological well-being
- Medical subject headings
- Nervous System Diseases, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Provision of an environmental control systemDevice
Part of standard clinical care for patients referred to the NHS Lothian environmental control service.
| Study group | Role | What they receive |
|---|---|---|
| Environmental control system users | Patients who are eligible for environmental control system users as part of standard clinical care. Receives: Device: Provision of an environmental control system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From baseline to 8 weeks post installation of the environmental control system.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start29 Jan 2024
- Primary completion27 May 2025
- Study completion27 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Neurologic DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Lothian
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07049419
- Sponsor's protocol ID
- AC23092
- Other IDs
- 23/PR/0917
- Acronym
- EC-MH
- Status last verified
- Jan 2026
- First submitted
- 19 Jun 2025
- Last updated
- 5 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD is not required to be shared.
Publications
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.
PubMed 29703090Terwee 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.
PubMed 34247326Henderson 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.
PubMed 42400500
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Environmental Controls on Mental Health
- ClinicalTrials.gov ID
- NCT07049419
- Acronym / sponsor ID
- EC-MH / AC23092
- Conditions
- Neurologic Disorders
- Keywords
- Environmental controls, Activities of daily living, Mental health, Self-help devices, Psychological well-being
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- NHS LothianOther government
- Study start
- 29 Jan 2024 (actual)
- Primary completion
- 27 May 2025 (actual)
- Study completion
- 27 May 2025 (actual)
- First posted
- 3 Jul 2025 (actual)
- Results
- Posted 7 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Environmental control system users | – | Device: Provision of an environmental control systemPatients who are eligible for environmental control system users as part of standard clinical care. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- NHS Lothian patients who have been referred to the Environmental Control Service and are eligible for environmental controls.
Key inclusion criteria (4 listed)
- Eligible for environmental control system (as per NHS Scotland criteria).
- New user (no previous intervention).
- Neurological condition.
- Cognitive ability to answer the questions and to give consent.
Key exclusion criteria (4 listed)
- Previous environmental control intervention.
- Patients requiring equipment not supplied by NHS Lothian's ECS (e.g. door interface).
- Patient recently diagnosed (within 6 months).
- Rapidly deteriorating condition.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Provision of an environmental control systemPart of standard clinical care for patients referred to the NHS Lothian environmental control service. | Device | Environmental control system users |
Primary outcome
Percentage of Participants Achieving MCID in PROMIS Global10 Score.
Time frame: From baseline to 8 weeks post installation of the environmental control system.
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.
Percentage of Participants Achieving MCID in the PIADS.
Time frame: From baseline to 8 weeks post installation of the environmental control system.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29703090Vessoyan 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.
- Background: PubMed 34247326Terwee 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.
- Derived from this study: PubMed 42400500Henderson 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.
- Individual participant dataSharing planned: No. IPD is not required to be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurologic Disorders, run by NHS Lothian at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Achieving MCID in PROMIS Global10 Score. (time frame: From baseline to 8 weeks post installation of the environmental control system.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07049419, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.