Feasibility of a Software App for Testing Inattention in Delirium

NCT ID: NCT02603380

Last Updated: 2015-11-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 48 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2015-06-30

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.

Conditions

Delirium

Study Design

• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Clinical staff

Clinicians in the Royal Infirmary of Edinburgh.

No intervention

Intervention Type: OTHER

This is an observational study. No intervention will be given.

Patients

Patients in intensive care units and general wards in the Royal Infirmary of Edinburgh.

No intervention

Intervention Type: OTHER

This is an observational study. No intervention will be given.

Interventions

No intervention

This is an observational study. No intervention will be given.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical Research Council

OTHER_GOV

Sponsor Role: collaborator

NHS Lothian

OTHER_GOV

Sponsor Role: collaborator

University of Glasgow

OTHER

Sponsor Role: collaborator

NHS Greater Glasgow and Clyde

OTHER

Sponsor Role: collaborator

Cambridge Cognition Ltd

INDUSTRY

Sponsor Role: collaborator

University of Edinburgh

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David J Stott

Role: PRINCIPAL_INVESTIGATOR

University of Glasgow

Elizabeth Wilson

Role: PRINCIPAL_INVESTIGATOR

NHS Lothian

Timothy Walsh

Role: PRINCIPAL_INVESTIGATOR

University of Edinburgh

Tara Quasim

Role: PRINCIPAL_INVESTIGATOR

University of Glasgow

Jonathan Evans

Role: PRINCIPAL_INVESTIGATOR

University of Glasgow

Christopher Weir

Role: PRINCIPAL_INVESTIGATOR

University of Edinburgh

Alexander Weir

Role: PRINCIPAL_INVESTIGATOR

Medical Devices Unit

Stuart Parks

Role: PRINCIPAL_INVESTIGATOR

Medical Devices Unit

Jenny Barnett

Role: STUDY_CHAIR

Cambridge Cognition Ltd

Other Identifiers

DelApp phase A

Identifier Type: -

Identifier Source: org_study_id