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Feasibility of a Software App for Testing Inattention in Delirium

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ClinicalTrials.gov Identifier: NCT02603380
Recruitment Status : Completed
First Posted : November 11, 2015
Last Update Posted : November 11, 2015
Sponsor:
Collaborators:
Medical Research Council
NHS Lothian
University of Glasgow
NHS Greater Glasgow and Clyde
Cambridge Cognition Ltd
Information provided by (Responsible Party):
University of Edinburgh

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.

Condition or disease Intervention/treatment
Delirium Other: No intervention

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.

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Study Type : Observational
Actual Enrollment : 48 participants
Time Perspective: Cross-Sectional
Official Title: Feasibility Study of a Software Application for Detection and Monitoring of Attentional Deficits in Delirium
Study Start Date : March 2015
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Group/Cohort Intervention/treatment
Clinical staff
Clinicians in the Royal Infirmary of Edinburgh.
Other: No intervention
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.
Other: No intervention
This is an observational study. No intervention will be given.




Primary Outcome Measures :
  1. Semi-structured interviews with clinicians and patients to produce a set of recommendations to refine and optimise the DelApp. [ Time Frame: Baseline ]
    Clinicians and patients who have used the DelApp will be interviewed using semi structured interviews.


Secondary Outcome Measures :
  1. System usability scale to measure the usability of the DelApp. [ Time Frame: Baseline ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Royal Infirmary of Edinburgh (RIE) general wards and intensive care units.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02603380


Sponsors and Collaborators
University of Edinburgh
Medical Research Council
NHS Lothian
University of Glasgow
NHS Greater Glasgow and Clyde
Cambridge Cognition Ltd
Investigators
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Principal Investigator: David J Stott University of Glasgow
Principal Investigator: Elizabeth Wilson NHS Lothian
Principal Investigator: Timothy Walsh University of Edinburgh
Principal Investigator: Tara Quasim University of Glasgow
Principal Investigator: Jonathan Evans University of Glasgow
Principal Investigator: Christopher Weir University of Edinburgh
Principal Investigator: Alexander Weir Medical Devices Unit
Principal Investigator: Stuart Parks Medical Devices Unit
Study Chair: Jenny Barnett Cambridge Cognition Ltd
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Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT02603380    
Other Study ID Numbers: DelApp phase A
First Posted: November 11, 2015    Key Record Dates
Last Update Posted: November 11, 2015
Last Verified: November 2015
Keywords provided by University of Edinburgh:
Delirium
Feasibility study
software application
qualitative
Additional relevant MeSH terms:
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Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders