Critical IllnessMENTALNCT05401461
Mobilisation in the EveNing to TreAt Delirium
A study testing Evening mobilisation in people with Critical Illness and Sleep Disturbance, run by University Hospitals Coventry and Warwickshire NHS Trust at 2 sites in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Sleep Disturbance, Mobility Limitation
- What is being tested?
- Evening mobilisation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 1 Jul 2022to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
University Hospitals Coventry & Warwickshire
Coventry, Midlands, CV2 2DX
Oxford University Hospitals NHS Foundation Trust
Oxford
About this study
Official title: Does Mobilisation in the Evening Reduce the Incidence of Delirium in Patients Admitted to Intensive Care: a Mixed-methods, Randomised Controlled Feasibility Study
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
- Will patients agree to be a part of this trial?
- Will they agree to the additional physiotherapy sessions offered in the evening?
- Will patients and staff members be happy for us to randomly select who receives this extra treatment?
Read the detailed description
The investigators hypothesise that mobilisation in the evening will promote more natural sleep, with patients becoming tired from physical exertion and plan to evaluate the impact this may have on reducing the incidence or duration of delirium.
A mixed-methods, two centre, randomised controlled feasibility study to establish the viability of conducting a larger multicentre RCT to test the effects of evening mobilisation on the incidence of ICU-acquired delirium.
Part 1 will evaluate whether it is possible to achieve acceptable recruitment and retention rates, intervention fidelity, and if the proposed data collection methods are appropriate.
Part 2 includes an acceptability analysis and qualitative evaluation, aiming to explore both patient and staff subjective experiences of the study intervention and proposed research methods (including willingness for randomisation and study outcome measures) and provide information to refine the study intervention (if required). The investigators will use principles of Normalisation Process Theory [28] and the NoMAD assessment tool [29] to assess the practicalities associated with implementing additional evening physiotherapy.
Treatment / Intervention The intervention will be delivered by a dedicated mobilisation team recruited from the study centres and will include trained ICU physiotherapists. Mobilisation will be delivered according to standardised procedures and established safety criteria. The intervention will begin on day 1 of admission or the first evening following recruitment.
After consultation with the responsible physician and nurse, patients will be approached between 19.00 and 21:00 to confirm suitability and consent to mobilise. Patients who are asleep will not be woken for the intervention. Mobilisation will be defined as a score of ≥ 2 on the Manchester mobility score (sit on the edge of the bed or higher), with actual mobilisation level achieved and duration of intervention based on clinical decision of the mobilisation therapists. Patients will also be offered the opportunity to engage in activities which may be part of their normal evening routines (e.g. brushing teeth, reading or watching television).
The intervention will be carried out for up to seven consecutive evenings. The intervention will be terminated if a) patient condition deteriorates irretrievably and physiotherapy is no longer appropriate, b) after seven evenings, or c) when the patient is discharged from the ICU. The intervention will not continue at secondary wards or units.
The evening mobilisation will be delivered in addition to any input from the MDT during normal daily working hours and will not replace any standard therapy.
- Being tested
- Evening mobilisation
- Keywords
- delirium, non-pharmacological, mobilisation, sleep, intensive care, ICU
- Medical subject headings
- Critical Illness, Parasomnias, Mobility Limitation, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evening mobilisationOther
Evening mobilisation delivered between (19.00 and 21.00) according to standardised procedures and established safety criteria. The intervention will begin on day 1 of admission or the first evening following recruitment. Mobilisation will be defined as a score of ≥ 2 on the Manchester mobility score (sit on the edge of the bed or higher), with actual mobilisation level achieved and duration of intervention based on clinical decision of the mobilisation therapists. Patients will also be offered the opportunity to engage in activities which may be part of their normal evening routines (e.g. brushing teeth, reading or watching television). The intervention will be carried out for up to seven consecutive evenings. The evening mobilisation will be delivered in addition to any input from the MDT during normal daily working hours and will not replace any standard therapy.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Evening mobilisation delivered between 7pm and 9pm Receives: Other: Evening mobilisation |
| Control | No intervention | Patients in the control arm will receive standard care which incorporates physiotherapy and mobilisation as appropriate between 8am and 5pm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Proportion of patients agreeing to take part out of all those invited
Measured: 3 month recruitment window
Retention rate
Proportion of participants who complete the intervention
Measured: Up to 7 days following recruitment
Intervention fidelity
Percentage of intervention sessions completed
Measured: Up to 7 days following recruitment
Secondary outcomes (4)
Incidence of delirium
Incidence of delirium assessed as a positive result on the CAM-ICU
Measured: During critical care stay, average of 2 weeks
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
Measured: During critical care stay, average of 2 weeks
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
Measured: During critical care stay, average of 2 weeks
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
Measured: At ICU discharge, average of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start1 Jul 2022
- Primary completion31 Oct 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Mixed methods, randomised controlled feasibility study
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Coventry and Warwickshire NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Oxford University Hospitals NHS Trust, University Hospital Schleswig-Holstein
- Responsible party
- Sponsor
- Investigators
- David McWilliams, PhD, Principal investigator, University Hospitals Coventry and Warwickshire NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05401461
- Sponsor's protocol ID
- DW584022
- Acronym
- MENTAL
- Status last verified
- May 2023
- First submitted
- 23 May 2022
- Last updated
- 1 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McWilliams DJ, King EB, Nydahl P, Darbyshire JL, Gallie L, Barghouthy D, Bassford C, Gustafson OD. Mobilisation in the EveNing to prevent and TreAt deLirium (MENTAL): a mixed-methods, randomised controlled feasibility trial. EClinicalMedicine. 2023 Jul 19;62:102101. doi: 10.1016/j.eclinm.2023.102101. eCollection 2023 Aug.
PubMed 37533416McWilliams D, King E, Nydahl P, Darbyshire JL, Gallie L, Barghouthy D, Bassford C, Gustafson O. Mobilisation in the EveNing to TreAt deLirium (MENTAL): protocol for a mixed-methods feasibility randomised controlled trial. BMJ Open. 2023 Feb 3;13(2):e066143. doi: 10.1136/bmjopen-2022-066143.
PubMed 36737097
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Mobilisation in the Evening Reduce the Incidence of Delirium in Patients Admitted to Intensive Care: a Mixed-methods, Randomised Controlled Feasibility Study
- ClinicalTrials.gov ID
- NCT05401461
- Acronym / sponsor ID
- MENTAL / DW584022
- Keywords
- delirium, non-pharmacological, mobilisation, sleep, intensive care, ICU
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University Hospitals Coventry and Warwickshire NHS TrustUniversity, hospital or other
- Collaborators
- Oxford University Hospitals NHS Trust, University Hospital Schleswig-Holstein
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 2 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Will patients agree to be a part of this trial?
- Will they agree to the additional physiotherapy sessions offered in the evening?
- Will patients and staff members be happy for us to randomly select who receives this extra treatment?
Detailed description
The investigators hypothesise that mobilisation in the evening will promote more natural sleep, with patients becoming tired from physical exertion and plan to evaluate the impact this may have on reducing the incidence or duration of delirium.
A mixed-methods, two centre, randomised controlled feasibility study to establish the viability of conducting a larger multicentre RCT to test the effects of evening mobilisation on the incidence of ICU-acquired delirium.
Part 1 will evaluate whether it is possible to achieve acceptable recruitment and retention rates, intervention fidelity, and if the proposed data collection methods are appropriate.
Part 2 includes an acceptability analysis and qualitative evaluation, aiming to explore both patient and staff subjective experiences of the study intervention and proposed research methods (including willingness for randomisation and study outcome measures) and provide information to refine the study intervention (if required). The investigators will use principles of Normalisation Process Theory [28] and the NoMAD assessment tool [29] to assess the practicalities associated with implementing additional evening physiotherapy.
Treatment / Intervention The intervention will be delivered by a dedicated mobilisation team recruited from the study centres and will include trained ICU physiotherapists. Mobilisation will be delivered according to standardised procedures and established safety criteria. The intervention will begin on day 1 of admission or the first evening following recruitment.
After consultation with the responsible physician and nurse, patients will be approached between 19.00 and 21:00 to confirm suitability and consent to mobilise. Patients who are asleep will not be woken for the intervention. Mobilisation will be defined as a score of ≥ 2 on the Manchester mobility score (sit on the edge of the bed or higher), with actual mobilisation level achieved and duration of intervention based on clinical decision of the mobilisation therapists. Patients will also be offered the opportunity to engage in activities which may be part of their normal evening routines (e.g. brushing teeth, reading or watching television).
The intervention will be carried out for up to seven consecutive evenings. The intervention will be terminated if a) patient condition deteriorates irretrievably and physiotherapy is no longer appropriate, b) after seven evenings, or c) when the patient is discharged from the ICU. The intervention will not continue at secondary wards or units.
The evening mobilisation will be delivered in addition to any input from the MDT during normal daily working hours and will not replace any standard therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Mixed methods, randomised controlled feasibility study
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Evening mobilisationEvening mobilisation delivered between 7pm and 9pm |
| Control | No intervention | –Patients in the control arm will receive standard care which incorporates physiotherapy and mobilisation as appropriate between 8am and 5pm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evening mobilisationEvening mobilisation delivered between (19.00 and 21.00) according to standardised procedures and established safety criteria. The intervention will begin on day 1 of admission or the first evening following recruitment. Mobilisation will be defined as a score of ≥ 2 on the Manchester mobility score (sit on the edge of the bed or higher), with actual mobilisation level achieved and duration of intervention based on clinical decision of the mobilisation therapists. Patients will also be offered the opportunity to engage in activities which may be part of their normal evening routines (e.g. brushing teeth, reading or watching television). The intervention will be carried out for up to seven consecutive evenings. The evening mobilisation will be delivered in addition to any input from the MDT during normal daily working hours and will not replace any standard therapy. | Other | Intervention |
Primary outcome
Recruitment rate
Time frame: 3 month recruitment window
Proportion of patients agreeing to take part out of all those invited
Retention rate
Time frame: Up to 7 days following recruitment
Proportion of participants who complete the intervention
Intervention fidelity
Time frame: Up to 7 days following recruitment
Percentage of intervention sessions completed
4 secondary outcomes
Incidence of delirium
Time frame: During critical care stay, average of 2 weeks
Duration of delirium
Time frame: During critical care stay, average of 2 weeks
Sleep quality
Time frame: During critical care stay, average of 2 weeks
Mobility level at critical care discharge
Time frame: At ICU discharge, average of 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
- Derived from this study: PubMed 37533416McWilliams DJ, King EB, Nydahl P, Darbyshire JL, Gallie L, Barghouthy D, Bassford C, Gustafson OD. Mobilisation in the EveNing to prevent and TreAt deLirium (MENTAL): a mixed-methods, randomised controlled feasibility trial. EClinicalMedicine. 2023 Jul 19;62:102101. doi: 10.1016/j.eclinm.2023.102101. eCollection 2023 Aug.
- Derived from this study: PubMed 36737097McWilliams D, King E, Nydahl P, Darbyshire JL, Gallie L, Barghouthy D, Bassford C, Gustafson O. Mobilisation in the EveNing to TreAt deLirium (MENTAL): protocol for a mixed-methods feasibility randomised controlled trial. BMJ Open. 2023 Feb 3;13(2):e066143. doi: 10.1136/bmjopen-2022-066143.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David McWilliams, PhD principal investigator
University Hospitals Coventry and Warwickshire NHS Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evening mobilisation in people with Critical Illness and Sleep Disturbance, run by University Hospitals Coventry and Warwickshire NHS Trust at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: 3 month recruitment window). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05401461, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2023.