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Completed

NCT Number: NCT07049419

The Impact of Environmental Controls on Mental Health

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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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

SMART Centre

Edinburgh, EH9 2HL, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Provision of an environmental control system

Device

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

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

NHS Lothian

Other Gov

Registry information

Acronym: EC-MH

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 3, 2025
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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