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Validating Studies to Assess the Diagnostic Accuracy of a Software Application for Detection and Monitoring of Attentional Deficits in Delirium

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ClinicalTrials.gov Identifier: NCT02590796
Recruitment Status : Completed
First Posted : October 29, 2015
Last Update Posted : May 24, 2018
Sponsor:
Collaborators:
Medical Research Council
NHS Lothian
University of Glasgow
NHS Greater Glasgow and Clyde
Cambridge Cognition Ltd
Information provided by (Responsible Party):
Alasdair MacLullich, University of Edinburgh

Brief Summary:

The study has two phases: Phase B and Phase C. The purpose of the Phase B study is to determine the performance (sensitivity and specificity) of a smartphone application (DelApp) to identify delirium in the whole inpatient sample. The study also aims to determine the performance (sensitivity and specificity) of the DelApp to discriminate between delirium (with or without dementia) and dementia (without delirium).

The purpose of the Phase C study is to determine the efficacy of the DelApp software application in detecting delirium in unselected patients in an inpatient sample and to determine the performance of the DelApp to discriminate between delirium and dementia. The study also aims to explore the performance of the DelApp in tracking change in cognitive function.


Condition or disease Intervention/treatment
Delirium Dementia Other: No intervention given to participants

Show Show detailed description

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Study Type : Observational
Actual Enrollment : 907 participants
Observational Model: Other
Time Perspective: Other
Official Title: MICA: Development of a Software Application for Detection and Monitoring of Attentional Deficits in Delirium
Actual Study Start Date : October 12, 2015
Actual Primary Completion Date : March 22, 2018
Actual Study Completion Date : March 22, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium Dementia

Group/Cohort Intervention/treatment
Hospitalised patients with delirium
hospitalised patients with delirium in general wards.
Other: No intervention given to participants
This is an observational study. Participants will receive no intervention.

Hospitalised patients with dementia/ no delirium
Hospitalised patients with a diagnosis of dementia who do not have delirium in general wards.
Other: No intervention given to participants
This is an observational study. Participants will receive no intervention.

Hospitalised patients with no delirium or dementia
Hospitalised patients with no delirium or dementia in general wards.
Other: No intervention given to participants
This is an observational study. Participants will receive no intervention.

Outpatients with dementia
People with a diagnosis of dementia who are living in the community.
Other: No intervention given to participants
This is an observational study. Participants will receive no intervention.

Healthy volunteers
Healthy volunteers who are living in the community who do not have a cognitive impairment.
Other: No intervention given to participants
This is an observational study. Participants will receive no intervention.

ICU delirium
Patients with delirium who are hospitalised in the intensive care units.
Other: No intervention given to participants
This is an observational study. Participants will receive no intervention.

ICU no delirium
Patients who do not have delirium who are hospitalised in intensive care units.
Other: No intervention given to participants
This is an observational study. Participants will receive no intervention.




Primary Outcome Measures :
  1. Diagnostic accuracy of the DelApp for diagnosing delirium [ Time Frame: Baseline ]
    DelApp score against delirium diagnosed using DSM-5 criteria in the whole inpatient sample.

  2. Diagnostic accuracy of the DelApp to discriminate between delirium (with or without dementia) and dementia (without delirium). [ Time Frame: Baseline ]
    DelApp score against delirium diagnosed using DSM-5 criteria in groups with dementia and delirium.


Secondary Outcome Measures :
  1. Accuracy of DelApp in measuring delirium severity [ Time Frame: Baseline ]
    DelApp score against score on Delirium Rating Scale revised 98 (DRS-R98).

  2. Length of stay [ Time Frame: up to 3 months ]
    length of stay in hospital

  3. Mortality [ Time Frame: 3 months ]
    Mortality at three months post assessment

  4. Discharge location [ Time Frame: up to 3 months ]
    Where patient is discharged to after hospital. e.g home, care home.

  5. Accuracy of DelApp to measure within-subject change in attentional functioning and delirium status over time [ Time Frame: 2 weeks ]
    Comparision of DelApp scores to DSM-5 criteria for delirium.

  6. Inter-rater agreement of the DelApp [ Time Frame: Baseline ]
    Assessed by comparing researcher assessment scores to the scores of clinical staff who are delirium specialists.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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

Scottish Dementia Research Network Register and Psychology, Philosophy and Language Science (PPLS) volunteer database.

Criteria

Inclusion Criteria:

  • General Wards

    • Aged 65 or over
    • Capacity to provide written, informed consent or the availability of a suitable relative or welfare guardian/attorney who is able to provide informed consent on behalf of the participant.

ICU

  • Aged 18 or over
  • Capacity to provide written, informed consent or the availability of a suitable relative or welfare guardian/attorney who is able to provide informed consent on behalf of the patient.

Exclusion Criteria:

  • General Wards

    • Unable to understand spoken task instructions
    • Vision or hearing impairment severe enough to preclude testing or interview
    • Photosensitive epilepsy

ICU

  • Unable to understand spoken task instructions
  • Pre-existing, known cognitive impairment including dementia
  • Vision or hearing impairment severe enough to preclude testing or interview
  • Photosensitive epilepsy
  • A score on the Richmond Agitation-Sedation Scale of below -3

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): NCT02590796


Locations
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United Kingdom
University of Edinburgh
Edinburgh, United Kingdom, EH16 4SA
University of Glasgow
Glasgow, United Kingdom, G4 0SF
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 Royal Infirmary of Edinburgh
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
Principal Investigator: Jennifer Barnett Cambridge Cognition Ltd

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Alasdair MacLullich, Professor of Geriatric Medicine, University of Edinburgh. Honorary Consultant, Medicine of the Elderly, Royal Infirmary of Edinburgh, University of Edinburgh
ClinicalTrials.gov Identifier: NCT02590796    
Other Study ID Numbers: DelApp
First Posted: October 29, 2015    Key Record Dates
Last Update Posted: May 24, 2018
Last Verified: May 2018
Keywords provided by Alasdair MacLullich, University of Edinburgh:
Delirium
Inattention
Medical device
Software application
Validation study
Diagnosis
Dementia
Additional relevant MeSH terms:
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Delirium
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms