Clinical trial NCT02603380: Feasibility of a Software App for Testing Inattention in Delirium
Official title: Feasibility Study of a Software Application for Detection and Monitoring of Attentional Deficits in Delirium
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delirium
Keywords: Delirium
Feasibility study
software application
qualitative
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: Medical Research Council
name: NHS Lothian
name: University of Glasgow
name: NHS Greater Glasgow and Clyde
name: Cambridge Cognition Ltd
First posted: 2015-11-11
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Royal Infirmary of Edinburgh (RIE) general wards and intensive care units.

Brief summary: This qualitative study aims to evaluate the usability of a smartphone application called DelApp. The study will assess usability and acceptability of the software app by asking 40 clinicians to administer the DelApp assessment to consented patient and clinicians. Feedback will be collected through semi-structured interviews with the clinicians. The feedback will be used to optimise the software application in preparation for formal validations studies.

Detailed description: 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 massive medical importance, delirium is grossly underdetected, with rates of formal detection of 20% or less.

Investigators previously developed a new neuropsychological test for the objective measurement of inattention in delirium, implemented on a computerised device (Delbox). A prototype software application for smartphones (DelApp) has been developed based on the 'Delbox' tests. Findings from two pilot studies suggest that the DelApp performs well as a method for objectively measuring attention in delirium.

As part of a new programme of work on attentional tests for delirium, formally funded by the Medical Research Council (grant value £1.01M), investigators plan further studies to refine the DelApp before conducting larger scale formal studies. The reasons for doing these additional studies are to: (1) shorten the duration of the DelApp assessment; (2) ask end users (i.e. clinicians) to evaluate the user interface; (3) gather feedback from end users regarding the ease of use of the test; and any other feedback from clinicians and patients; and finally (4) develop the DelApp software application further based on user feedback.

Here investigators propose a preliminary qualitative study to evaluate feasibility of the optimised DelApp test (points 2 and 3). Investigators will assess usability and acceptability by asking 40 clinical staff to administer the DelApp test to consented patients (N=10) and colleagues (approximately N=30). Feedback will be collected from clinicians and patients through semi-structured interviews. The outcomes of this feasibility study will make further optimisation of the app possible, in preparation for formal validation studies.

Eligibility criteria: Inclusion Criteria:

* Native or fluent English speaker

  * Capacity to give consent to participate in the study
  * Aged 65 or over

Exclusion Criteria:

* Vision, hearing or speech impairment severe enough to preclude testing and interview.

  * Known or suspected cognitive impairment including dementia
  * Photosensitive epilepsy

Primary outcomes:
measure: Semi-structured interviews with clinicians and patients to produce a set of recommendations to refine and optimise the DelApp.
timeFrame: Baseline
Secondary outcomes:
measure: System usability scale to measure the usability of the DelApp.
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
affiliation: University of Glasgow
name: David J Stott
role: PRINCIPAL_INVESTIGATOR
affiliation: NHS Lothian
name: Elizabeth Wilson
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Edinburgh
name: Timothy Walsh
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Glasgow
name: Tara Quasim
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Glasgow
name: Jonathan Evans
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Edinburgh
name: Christopher Weir
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical Devices Unit
name: Alexander Weir
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical Devices Unit
name: Stuart Parks
role: PRINCIPAL_INVESTIGATOR
affiliation: Cambridge Cognition Ltd
name: Jenny Barnett
role: STUDY_CHAIR
References: