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

NCT02590796 | Completed

• 1 other identifier: DelApp
• Study Type: observational
• Target: 907
• Locations: 1 country
• Sites: 2

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.

Conditions

Delirium; Dementia

Keywords

Delirium; Inattention; Medical device; Software application; Validation study; Diagnosis; Dementia

Outcome Measures

Primary Outcomes (2)

• Diagnostic accuracy of the DelApp for diagnosing delirium

  DelApp score against delirium diagnosed using DSM-5 criteria in the whole inpatient sample.

  Baseline

• Diagnostic accuracy of the DelApp to discriminate between delirium (with or without dementia) and dementia (without delirium).

  DelApp score against delirium diagnosed using DSM-5 criteria in groups with dementia and delirium.

  Baseline

Secondary Outcomes (6)

• Accuracy of DelApp in measuring delirium severity

  Baseline

• Length of stay

  up to 3 months

• Mortality

  3 months

• Discharge location

  up to 3 months

• Accuracy of DelApp to measure within-subject change in attentional functioning and delirium status over time

  2 weeks

Study Arms (7)

Hospitalised patients with delirium

hospitalised patients with delirium in general wards.

Other: No intervention given to participants

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

Hospitalised patients with no delirium or dementia

Hospitalised patients with no delirium or dementia in general wards.

Other: No intervention given to participants

Outpatients with dementia

People with a diagnosis of dementia who are living in the community.

Other: No intervention given to participants

Healthy volunteers

Healthy volunteers who are living in the community who do not have a cognitive impairment.

Other: No intervention given to participants

ICU delirium

Patients with delirium who are hospitalised in the intensive care units.

Other: No intervention given to participants

ICU no delirium

Patients who do not have delirium who are hospitalised in intensive care units.

Other: No intervention given to participants

Interventions

No intervention given to participants OTHER

This is an observational study. Participants will receive no intervention.

Healthy volunteers; Hospitalised patients with delirium; Hospitalised patients with dementia/ no delirium; Hospitalised patients with no delirium or dementia; ICU delirium; ICU no delirium; Outpatients with dementia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Edinburgh: lead
• Medical Research Council: collaborator
• NHS Lothian: collaborator
• University of Glasgow: collaborator
• NHS Greater Glasgow and Clyde: collaborator
• Cambridge Cognition Ltd: collaborator

Study Sites (2)

University of Edinburgh

Edinburgh, EH16 4SA, United Kingdom

Location

University of Glasgow

Glasgow, G4 0SF, United Kingdom

Location

Related Publications (1)

• Rutter LM, Nouzova E, Stott DJ, Weir CJ, Assi V, Barnett JH, Clarke C, Duncan N, Evans J, Green S, Hendry K, McGinlay M, McKeever J, Middleton DG, Parks S, Shaw R, Tang E, Walsh T, Weir AJ, Wilson E, Quasim T, MacLullich AMJ, Tieges Z. Diagnostic test accuracy of a novel smartphone application for the assessment of attention deficits in delirium in older hospitalised patients: a prospective cohort study protocol. BMC Geriatr. 2018 Sep 17;18(1):217. doi: 10.1186/s12877-018-0901-5.

  PMID: 30223771 DERIVED

MeSH Terms

Conditions

Delirium; Dementia; Disease

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Pathologic Processes

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Geriatric Medicine, University of Edinburgh. Honorary Consultant, Medicine of the Elderly, Royal Infirmary of Edinburgh

Study Record Dates

• First Submitted: October 14, 2015
• First Posted: October 29, 2015
• Study Start: October 12, 2015
• Primary Completion: March 22, 2018
• Study Completion: March 22, 2018
• Last Updated: May 24, 2018

Record last verified: 2018-05

Locations

GB (2)