The Impact of Environmental Controls on Mental Health

NCT07049419 | Completed Results

• 2 other identifiers: AC2309223/PR/0917
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurologic Disorders

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (1)

Environmental control system users

Patients who are eligible for environmental control system users as part of standard clinical care.

Device: Provision of an environmental control system

Interventions

Provision of an environmental control system DEVICE

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

Environmental control system users

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

NHS Lothian patients who have been referred to the Environmental Control Service and are eligible for environmental controls.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NHS Lothian: lead

Study Sites (1)

SMART Centre

Edinburgh, EH9 2HL, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 29703090 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.

  PMID: 34247326 BACKGROUND

MeSH Terms

Conditions

Nervous System Diseases; Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Limitations and Caveats

The sample size and demographic characteristics may limit generalisability. All outcome analyses are reported in the corresponding results tables.

Results Point of Contact

• Title: Graham Henderson
• Organization: NHS Lothian

graham.henderson@nhs.scot

+441315379422

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2025
• First Posted: July 3, 2025
• Study Start: January 29, 2024
• Primary Completion: May 27, 2025
• Study Completion: May 27, 2025
• Last Updated: May 5, 2026
• Results First Posted: April 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)