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The Impact of Environmental Controls on Mental Health

The Impact of Environmental Controls on Mental Health

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07049419
Acronym
EC-MH
Enrollment
5
Registered
2025-07-03
Start date
2024-01-29
Completion date
2025-05-27
Last updated
2026-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurologic Disorders

Keywords

Environmental controls, Activities of daily living, Mental health, Self-help devices, Psychological well-being

Brief 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. 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.

Interventions

DEVICEProvision of an environmental control system

Part of standard clinical care for patients referred to the NHS Lothian environmental control service.

Sponsors

NHS Lothian
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Participants Achieving MCID in PROMIS Global10 Score.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.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.

Countries

United Kingdom

Participant flow

Recruitment details

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.

Baseline characteristics

Characteristic
Age, Continuous60.6 Years
STANDARD_DEVIATION 8.2
Region of Enrollment
United Kingdom
5 Participants
Sex: Female, Male
Female
3 Participants
Sex: Female, Male
Male
2 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 5
other
Total, other adverse events
0 / 5
serious
Total, serious adverse events
0 / 5

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 6, 2026