NCT04272684

Brief Summary

Spending time on intensive care can affect people in many different ways. Ability to move, walk, concentrate and remember events can all be affected. People may find their mood is altered and anxiety, stress and reduced confidence are common. These symptoms are frequently grouped together in a term called 'post intensive care syndrome'. Recovery often takes time and can be challenging. Returning to driving is an important milestone and can enable individuals to return to important activities such as work and hobbies. As a complex task, driving requires individuals to do many things at once which initially can be demanding. Currently there is limited guidance about driving after a period of time on intensive care. This study is being carried out to increase understanding of driving difficulties after a stay on intensive care and how successful and safe return to driving can be ensured. It is known that a stay on intensive care can have many effects on the body but currently the best advice to give to patients about returning to drive is unknown. The investigators would like to gather information on how many people do and do not return to driving and the reasons for this so people can be provided with more accurate information in the future. Additionally, it is important to find out if the driving assessment is practical and achievable for individuals who have had a stay on intensive care.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 4, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 17, 2020

Completed
9 days until next milestone

Study Start

First participant enrolled

February 26, 2020

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

June 4, 2021

Status Verified

June 1, 2021

Enrollment Period

2.7 years

First QC Date

February 4, 2020

Last Update Submit

June 3, 2021

Conditions

Post Intensive Care Syndrome

Keywords

Driving

Outcome Measures

Primary Outcomes (1)

  • Incidence of new driving impairments as determined by a DVLA approved driving assessment

    DVLA approved driving assessment will be completed 2 months after discharge from hospital.

    2 months

Secondary Outcomes (5)

  • Patient-reported driving status

    3, 6 and 12 month time-ponts

  • To evaluate acceptability of the driving assessment

    2, 3, 6 and 12 month time-points

  • To evaluate feasibility of the driving assessment

    2, 3, 6 and 12 month time-points

  • Enablers of driving resumption

    2, 3, 6 and 12 month time-points

  • Barriers to driving resumption

    2, 3, 6 and 12 month time-points

Study Arms (1)

Interventional

EXPERIMENTAL

Driving Assessment

Other: Driving Assessment

Interventions

Driving AssessmentOTHER

Participants will undergo a driving assessment approximately two months after returning home from hospital

Interventional

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult \>18 years
  • Severe critical illness and high risk PICS as defined by 72 hours or more of invasive mechanical ventilation in ICU
  • Previously driving car in the 12 months prior to admission and currently holds UK category B driving licence (i.e.: car category)
  • Able and willing to travel to Carshalton, Surrey and undergo full driving ability assessment and study follow up for a duration of 12 months
  • Intention to resume driving, or has already resumed driving

You may not qualify if:

  • DVLA-confirmed long term driving ineligibility (as per existing DVLA medical guidance)
  • Invalid, revoked or expired driving licence
  • Deemed unlikely to return to independent living status due to e.g.: severe neurological injury, advanced cancer, progressive/degenerative condition, or other
  • High risk of illness recurrence or readmission to hospital
  • Social or neuropsychiatric circumstances deemed likely to adversely study participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guys and St Thomas NHS Foundation Trust

London, SE1 9RT, United Kingdom

RECRUITING

Related Publications (1)

  • Apps C, Brooks K, Rose L, Meyer J, Pattison N. "Back on the road": Exploring experiences of driving resumption in patients recovering from critical illness. Aust Crit Care. 2025 Nov;38(6):101442. doi: 10.1016/j.aucc.2025.101442. Epub 2025 Oct 24.

    PMID: 41138521DERIVED

MeSH Terms

Conditions

postintensive care syndrome

Study Officials

  • Joel Meyer, MD

    Guy's and St Thomas' NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chloe Apps, MSc

CONTACT

02071888070chloe.apps@gstt.nhs.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2020

First Posted

February 17, 2020

Study Start

February 26, 2020

Primary Completion

November 1, 2022

Study Completion

February 1, 2023

Last Updated

June 4, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)