Mobilisation in the EveNing to TreAt Delirium

NCT05401461 | Completed

• 1 other identifier: DW584022
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 2

Brief 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. 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. 1.Will patients agree to be a part of this trial?
2. 2.Will they agree to the additional physiotherapy sessions offered in the evening?
3. 3.Will patients and staff members be happy for us to randomly select who receives this extra treatment?

Conditions

Critical Illness; Sleep Disturbance; Mobility Limitation; Intensive Care Unit Delirium

Keywords

delirium; non-pharmacological; mobilisation; sleep; intensive care; ICU

Outcome Measures

Primary Outcomes (3)

• Recruitment rate

  Proportion of patients agreeing to take part out of all those invited

  3 month recruitment window

• Retention rate

  Proportion of participants who complete the intervention

  Up to 7 days following recruitment

• Intervention fidelity

  Percentage of intervention sessions completed

  Up to 7 days following recruitment

Secondary Outcomes (4)

• Incidence of delirium

  During critical care stay, average of 2 weeks

• Duration of delirium

  During critical care stay, average of 2 weeks

• Sleep quality

  During critical care stay, average of 2 weeks

• Mobility level at critical care discharge

  At ICU discharge, average of 2 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

Evening mobilisation delivered between 7pm and 9pm

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

Interventions

Evening mobilisation OTHER

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospitals Coventry and Warwickshire NHS Trust: lead
• Oxford University Hospitals NHS Trust: collaborator
• University Hospital Schleswig-Holstein: collaborator

Study Sites (2)

University Hospitals Coventry & Warwickshire

Coventry, Midlands, CV2 2DX, United Kingdom

Location

Oxford University Hospitals NHS Foundation Trust

Oxford, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 37533416 DERIVED

• McWilliams 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.

  PMID: 36737097 DERIVED

MeSH Terms

Conditions

Critical Illness; Parasomnias; Mobility Limitation; Delirium

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Signs and Symptoms; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Neurocognitive Disorders

Study Officials

• David McWilliams, PhD

  University Hospitals Coventry and Warwickshire NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All outcomes will be collected by an independent researcher blinded to group allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Mixed methods, randomised controlled feasibility study

Study Record Dates

• First Submitted: May 23, 2022
• First Posted: June 2, 2022
• Study Start: July 1, 2022
• Primary Completion: October 31, 2022
• Study Completion: November 30, 2022
• Last Updated: June 1, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)