Trial Outcomes & Findings for The Impact of Environmental Controls on Mental Health (NCT NCT07049419)

NCT ID: NCT07049419

Last Updated: 2026-05-05

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

5 participants

Primary outcome timeframe

From baseline to 8 weeks post installation of the environmental control system.

Results posted on

2026-05-05

Participant Flow

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.

Participant milestones

Participant milestones
Measure
Environmental Control System Users
Patients who are eligible for environmental control system users as part of standard clinical care.
Overall Study
STARTED
5
Overall Study
COMPLETED
5
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Environmental Control System Users
n=5 Participants
Patients who are eligible for environmental control system users as part of standard clinical care.
Age, Continuous
60.6 Years
STANDARD_DEVIATION 8.2 • n=5 Participants
Sex: Female, Male
Female
3 Participants
n=5 Participants
Sex: Female, Male
Male
2 Participants
n=5 Participants
Region of Enrollment
United Kingdom
5 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Environmental Control System Users
n=5 Participants
Patients who are eligible for environmental control system users as part of standard clinical care.
Percentage of Participants Achieving MCID in PROMIS Global10 Score.
5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Environmental Control System Users
n=5 Participants
Patients who are eligible for environmental control system users as part of standard clinical care.
Percentage of Participants Achieving MCID in the PIADS.
4 Participants

Adverse Events

Environmental Control System Users

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Graham Henderson

NHS Lothian

Phone: +441315379422

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place