DeliriumNCT02603380
Feasibility of a Software App for Testing Inattention in Delirium
An observational study of Delirium, run by University of Edinburgh.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Royal Infirmary of Edinburgh (RIE) general wards and intensive care units.
Who may be able to join
- Native or fluent English speaker
- Capacity to give consent to participate in the study
- Aged 65 or over
Who cannot join
- Vision, hearing or speech impairment severe enough to preclude testing and interview.
- Known or suspected cognitive impairment including dementia
- Photosensitive epilepsy
About this study
Official title: 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.
Read the 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
- Being tested
- No intervention
- Keywords
- Delirium, Feasibility study, software application, qualitative
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
This is an observational study. No intervention will be given.
| Study group | Role | What they receive |
|---|---|---|
| Clinical staff | Clinicians in the Royal Infirmary of Edinburgh. Receives: Other: No intervention | |
| Patients | Patients in intensive care units and general wards in the Royal Infirmary of Edinburgh. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Semi-structured interviews with clinicians and patients to produce a set of recommendations to refine and optimise the DelApp.
Clinicians and patients who have used the DelApp will be interviewed using semi structured interviews.
Measured: Baseline
Secondary outcomes (1)
System usability scale to measure the usability of the DelApp.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2015 (estimated)
- Study startMar 2015
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council, NHS Lothian, University of Glasgow, NHS Greater Glasgow and Clyde, Cambridge Cognition Ltd
- Responsible party
- Sponsor
- Investigators
- David J Stott, Principal investigator, University of GlasgowElizabeth Wilson, Principal investigator, NHS LothianTimothy Walsh, Principal investigator, University of EdinburghTara Quasim, Principal investigator, University of GlasgowJonathan Evans, Principal investigator, University of GlasgowChristopher Weir, Principal investigator, University of EdinburghAlexander Weir, Principal investigator, Medical Devices UnitStuart Parks, Principal investigator, Medical Devices Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02603380
- Sponsor's protocol ID
- DelApp phase A
- Status last verified
- Nov 2015
- First submitted
- 19 Oct 2015
- Last updated
- 11 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of a Software Application for Detection and Monitoring of Attentional Deficits in Delirium
- ClinicalTrials.gov ID
- NCT02603380
- Acronym / sponsor ID
- DelApp phase A
- Conditions
- Delirium
- Keywords
- Delirium, Feasibility study, software application, qualitative
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- Medical Research Council, NHS Lothian, University of Glasgow, NHS Greater Glasgow and Clyde, Cambridge Cognition Ltd
- Study start
- Mar 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 11 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinical staff | – | Other: No interventionClinicians in the Royal Infirmary of Edinburgh. |
| Patients | – | Other: No interventionPatients in intensive care units and general wards in the Royal Infirmary of Edinburgh. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Royal Infirmary of Edinburgh (RIE) general wards and intensive care units.
Key inclusion criteria (3 listed)
- Native or fluent English speaker
Key exclusion criteria (3 listed)
- Vision, hearing or speech impairment severe enough to preclude testing and interview.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionThis is an observational study. No intervention will be given. | Other | Clinical staff, Patients |
Primary outcome
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.
1 secondary outcome
System usability scale to measure the usability of the DelApp.
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David J Stott principal investigator
University of Glasgow
Elizabeth Wilson principal investigator
NHS Lothian
Timothy Walsh principal investigator
University of Edinburgh
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium, run by University of Edinburgh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Semi-structured interviews with clinicians and patients to produce a set of recommendations to refine and optimise the DelApp. (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2015.