Critical Illness Clinical Trial
— MENTALOfficial title:
Does Mobilisation in the Evening Reduce the Incidence of Delirium in Patients Admitted to Intensive Care: a Mixed-methods, Randomised Controlled Feasibility Study
NCT number | NCT05401461 |
Other study ID # | DW584022 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 1, 2022 |
Est. completion date | November 30, 2022 |
Verified date | May 2023 |
Source | University Hospitals Coventry and Warwickshire NHS Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Patients with severe illness require lifesaving treatment in intensive care units. Around a third of patients admitted to intensive care develop delirium. This is a severe state of confusion. Delirium can be a frightening experience. Patients suffering from delirium can find it difficult to think clearly or understand what is happening. In some cases delirium can cause people to see or hear things that are not really there. Patients who develop delirium tend to spend longer in hospital and have worse overall outcomes. A major cause for the development of delirium is poor sleep. Previous research suggests that delirium levels can be reduced when patients are more active. The investigators have noticed that when patients in intensive care have physiotherapy during the day, they are often very tired and fall asleep quickly afterwards. The investigators think that patients who have physiotherapy in the evening will sleep better overnight and hope this will subsequently reduce the number who develop delirium. To answer this question the investigators need to compare patients who are active in the evening with those who only have physiotherapy sessions during the day. Before a full study can take place it is important to make sure it is designed in the best way. To do this, 60 patients will be recruited from 2 hospitals in the UK over 6 months. Half of those who agree to take part will be seen by the physiotherapist in the evening, the other half will not. The investigators will then ask the following questions before deciding whether to do a full study 1. Will patients agree to be a part of this trial? 2. Will they agree to the additional physiotherapy sessions offered in the evening? 3. Will patients and staff members be happy for us to randomly select who receives this extra treatment?
Status | Completed |
Enrollment | 58 |
Est. completion date | November 30, 2022 |
Est. primary completion date | October 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Adults (=18 years) - Admitted to ICU, - Able to respond to verbal stimulus (Richmond Agitation Sedation Scale = -3) - Expected to stay in the ICU for at least 24 hours. Exclusion Criteria: - Death expected within the next 72 hours, - Immobility prior to admission, - Mobilisation contraindicated (e.g., spinal injury), - Delirium diagnosis during this ICU admission, - Acute or subacute severe neurological deficit or injury; - Severe psychiatric illness (not including depression) or developmental problems; - Suspected or confirmed drug or alcohol intoxication/overdose or withdrawal. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | University Hospitals Coventry & Warwickshire | Coventry | Midlands |
United Kingdom | Oxford University Hospitals NHS Foundation Trust | Oxford |
Lead Sponsor | Collaborator |
---|---|
University Hospitals Coventry and Warwickshire NHS Trust | Oxford University Hospitals NHS Trust, University Hospital Schleswig-Holstein |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recruitment rate | Proportion of patients agreeing to take part out of all those invited | 3 month recruitment window | |
Primary | Retention rate | Proportion of participants who complete the intervention | Up to 7 days following recruitment | |
Primary | Intervention fidelity | Percentage of intervention sessions completed | Up to 7 days following recruitment | |
Secondary | Incidence of delirium | Incidence of delirium assessed as a positive result on the CAM-ICU | During critical care stay, average of 2 weeks | |
Secondary | Duration of delirium | counted at 12-hour periods; the end of delirium is defined when patients are delirium-negative for 24h or discharged to the ward | During critical care stay, average of 2 weeks | |
Secondary | Sleep quality | as an average and assessed over time using the Richard Campbell Sleep Questionnaire. This provides a score from 0 - 60, with higher scores representing better quality of sleep | During critical care stay, average of 2 weeks | |
Secondary | Mobility level at critical care discharge | Assessed using the Manchester mobility score. Scores range from 1-7 with higher scores representing higher levels of mobility | At ICU discharge, average of 2 weeks |
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