Validation studies of a software application for detecting delirium
Research type
Research Study
Full title
Validation studies to assess the diagnostic accuracy of a software application for detection and monitoring of attentional deficits in delirium
IRAS ID
172885
Contact name
Alasdair MacLullich
Contact email
Duration of Study in the UK
1 years, 7 months, 31 days
Research summary
Delirium is an acute, serious syndrome involving abnormalities in attention, arousal and cognition. Delirium affects 1 in 8 hospital patients.
Delirium is linked to a higher risk of death, increased length of stay, and substantial patient and carer distress. Despite its medical importance, delirium is grossly under-detected, with rates of formal detection of 20% or less.
We previously developed a new neuropsychological test for the objective measurement of inattention in delirium, implemented on a computerised device (Delbox). More recently we have developed a software application (DelApp) for smartphones based on the 'Delbox' tests.
Findings from two pilot studies suggest that the DelApp performs well as a method for objectively measuring inattention and to help identify delirium.
The studies in the present application are part of a larger programme of work funded by the Medical Research Council (grant value £1.01M) on the optimisation and clinical validation of the DelApp, which consists of three stages: Phase A - DelApp optimisation and feasibility testing; Phase B - case-control studies in selected patients; and Phase C - clinical validation studies in unselected patients. We aim to generate a software product which will be licensed and commercially available to healthcare organisations.
Recently we performed a study approved by the South East Scotland REC (ref 15/SC00/19) to evaluate the feasibility of the DelApp (Phase A) through staff and patient interviews. The feedback was overall very positive; the DelApp was considered to be user-friendly and acceptable to patients and staff. We are now refining the DelApp in preparation for larger validation studies.
We propose to carry out the Phase B/C studies in general and acute medical wards and Intensive Care Units. The main objectives are (a) to measure diagnostic performance of the DelApp in selected patients and to define cut-off points (Phase B); and (b) to evaluate the diagnostic performance in unselected patient groups (Phase C).
REC name
Scotland A: Adults with Incapacity only
REC reference
15/SS/0104
Date of REC Opinion
31 Jul 2015
REC opinion
Further Information Favourable Opinion