Dementia Clinical Trial
Official title:
MICA: Development of a Software Application for Detection and Monitoring of Attentional Deficits in Delirium
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.
The investigators previously developed a new neuropsychological test for the objective
measurement of inattention in delirium, which was implemented on a purpose-built computerised
device (Delbox). A prototype software application (DelApp) for smartphones has now been
developed based on the same test.
The DelApp has many advantages over existing tests, including objectivity, automated scoring
and ease-of-use. Studies in 30 hospital patients showed highly comparable performance between
the Delbox and DelApp. Further proof-of-principle single-rater studies using the DelApp in
more than 200 hospital patients have provided additional evidence of good performance of the
DelApp.
Though there are strong positive findings from investigator pilot studies, larger-scale
formal studies with blinded raters and more representative patient samples are now required.
The proposed study is part of a larger programme of work funded by the Medical Research
Council (grant value £1.01M) on the optimisation and clinical validation of the DelApp, which
consists of three stages: Phase A - optimisation of the DelApp and feasibility testing (REC
no 15/SC00/19); Phase B - case-control studies in selected patients; and Phase C - validation
studies in unselected patients. Ultimately investigators aim to generate a software product
which will be fully licensed and commercially available to healthcare organisations.
The proposed Phase B studies will be carried out in hospitalised patients in general and
acute medical wards and ICU. The objectives of these studies are (a) to assess diagnostic
performance of the DelApp in discrete patient groups and to inform optimal cut-points (Phase
B); and (b) to evaluate the diagnostic performance of the DelApp in unselected patients
(Phase C). The studies will also contribute to a better understanding of the nature of
neuropsychological deficits underlying delirium. At the end of these studies, the DelApp may
be modified depending on the study results. Investigators will select the stimuli and
subtests that provide the best balance of sensitivity and specificity.
Two case-control studies will be conducted involving patients recruited from general and
acute wards (Study B.1) and ICU (Study B.2). Each study will run in two sites, i.e. the Royal
Infirmary of Edinburgh (RIE) and the Glasgow Royal Infirmary (GRI). The performance of the
DelApp (index test) against reference standard diagnosis will be independently assessed by
two trained raters, with one pair of raters on each site. As in our prior case-control
studies, convenience samples will be used, where clinicians are asked to identify patients in
the target groups.
Hospitalised patients will be asked to undertake a number of tests at their bedside. These
tests will be administered to patients once only. Patients will be visited by two different
researchers on the same day, with a gap of approximately 15-60 min between assessment visits
assuming that consent is provided in the first visit. The first visit will involve assessment
of capacity and (in those thought likely to be capable of giving consent) obtaining informed
consent, as well as assessment of delirium (reference tests) and cognition. The second visit
will involve the DelApp assessment (index test). Thus, the index test and reference tests are
administered by independent raters. Where the patient is unable to provide consent for
themselves, proxy consent will be sought, and if granted, the same visits as above will
occur.
The Phase C formal validation studies have a similar design to the case-control studies. The
main difference is that unselected samples of patients will be recruited from general and
acute medical wards (Study C.1) and ICU (Study C.2) in the GRI and RIE.
A subset of patients in studies C.1 and C.2 (N=60 combined) will undergo up to 4 repeat
assessments (at least one day apart), along with the reference standard, to explore the
performance of the DelApp in tracking change in cognitive function.
In the longitudinal assessments, researchers will ask patients able to provide consent at the
time of recruitment if they consent to subsequent assessments even if at the time of these
subsequent assessments the patient lacks capacity. However, during the subsequent
assessments, it will be carefully checked if the patient assents to continue their
participation in the study. In patients who initially lack capacity and have been included
through consent from a legal proxy, and who are undergoing serial assessments, researchers
will seek informed consent from patients at the beginning of each new testing session. If the
patient regains capacity after the final assessment, the investigators will seek
retrospective consent from the patient where possible.
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