Feasibility of a Software App for Testing Inattention in Delirium

November 9, 2015 updated by: University of Edinburgh

Feasibility Study of a Software Application for Detection and Monitoring of Attentional Deficits in Delirium

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

48

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Royal Infirmary of Edinburgh (RIE) general wards and intensive care units.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
System usability scale to measure the usability of the DelApp.
Time Frame: Baseline
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Edinburgh

Collaborators

Medical Research Council
NHS Lothian
NHS Greater Glasgow and Clyde
University of Glasgow
Cambridge Cognition Ltd

Investigators

  • Principal Investigator: Elizabeth Wilson, NHS Lothian
  • Study Chair: Jenny Barnett, Cambridge Cognition Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

October 19, 2015

First Submitted That Met QC Criteria

November 9, 2015

First Posted (Estimate)

November 11, 2015

Study Record Updates

Last Update Posted (Estimate)

November 11, 2015

Last Update Submitted That Met QC Criteria

November 9, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DelApp phase A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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