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.
COMPLETED
5 participants
From baseline to 8 weeks post installation of the environmental control system.
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
| 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
| 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
| 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
| 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 adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place