Clinical trial NCT06240897: CURATE.Dtx as a Diagnostic and Management Tool for Delirium
Official title: Exploring the Feasibility of Digital Intervention Games as a Diagnostic and Management Tool for Delirium at SGH Inpatient Wards
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Delirium
Keywords: digital health
digital diagnostic
Lead sponsor: Institute for Digital Medicine (WisDM)
Sponsor class: OTHER
Collaborators: name: Singapore General Hospital
name: National University of Singapore
First posted: 2024-02-05
Enrollment: 20
Sex: ALL
Minimum age (years): 65
Maximum age (years): 99
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Inpatient delirium incidence is widely documented in international and local studies, however, there is no viable and labour-free delirium detection and management tool. CURATE.DTx is our tablet ready, multi-tasking serious game, that leverage a small data artificial intelligence-derived platform that can dynamically personalise cognitive training by modifying the game intensity. The main aims of this study are to explore the feasibility and usability of this new digital tool to aid in the delirium screening and management of at-risk delirium hospitalized patients.

Detailed description: Delirium is a neurobehavioral syndrome caused by the acute and transient impairment of brain activity. The clinical context usually involves a vulnerable patient, susceptible to predisposing factors, such as clinical illness, cognitive and sensory deficits, with precipitating factors occurring during the period of hospitalization. Although widely documented in international and local studies, there is no viable and labour-free delirium detection tool. CURATE.DTx is our tablet ready, multi-tasking serious game, that leverage a small data artificial intelligence-derived platform that can dynamically personalise cognitive training by modifying the game intensity.

This is a single-centre, single-arm prospective cohort feasibility study. Hospitalised adults \>65years old will be invited to trial the digital cognitive games. Patient experience and usability will be assessed at the end of the intervention through surveying methods. Acceptability, demand, implementation, practicality and limited accuracy testing will be assessed.

The investigators will recruit 25-50 inpatients (\>65 years old adults) from the medical wards in SGH from November 2023 to Jan 2024.

Potential participants will be approached by the SGH team in person to provide more information about the study. Participants will be screened by the SGH research team for eligibility at initial contact.

Eligible participants will be invited to complete a daily cognitive evaluation session consisting of a cognitive training game session, followed by a 4 'A's Test - a well-validated bedside tool, which helps practitioners detect delirium in day-to-day practice, as well as an MMSE test as an additional measure. CURATE.DTx is a self-guided digital game-based multitasking intervention that involves a combination of four subtasks played simultaneously. The game will be played by each participant via a study-provided tablet. During first session prior to commencing data collection, a trained trial team member will explain in detail how to play the game-based multitasking intervention. The session will require 12 minutes of gameplay for a minimum of three days and up to five days for a total duration of hospitalisation. Participants will also be encouraged to play an optional digital game that is designed to help with their emotional and cognitive health. Deidentified game play data will be recorded.

Upon completing the game sessions, a survey will be administered to gather patients experience whilst using the digital tool as well as feedback on the interaction with the interface itself.

Eligibility criteria: Inclusion Criteria:

* Admitted to the medical ward in SGH
* Age \>=65 years old
* Patients with a life expectancy of at least 1 month

Exclusion Criteria:

* Pregnant or breastfeeding women
* Patients physically incapable of using computer tablets (either due to vision loss or dominant hand weakness)
* Patients who cannot understand spoken the English language.
* Patients who are unable to give informed consent.

Primary outcomes:
measure: Patient Acceptability
timeFrame: 30 minutes
measure: Trial Team Members Acceptability
timeFrame: 30 minutes
measure: Demand
timeFrame: Throughout trial completion,up to 1 year
measure: Implementation
timeFrame: Throughout trial completion, up to 1 year
measure: Practicality
timeFrame: 30 minutes
Secondary outcomes:
measure: Usability
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore General Hospital
Study officials:
affiliation: The Institute for Digital Medicine (WisDM)
name: Dean Ho, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Singapore General Hospital
name: Esther M Fan Peijin
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kee, Theodore & Weiyan, Chee & Blasiak, Agata & Chong, Jordan & Chen, Jonna & Yeo, B.T. Thomas & Ho, Dean & Asplund, Christopher. (2019). Harnessing CURATE.AI as a Digital Therapeutics Platform by Identifying N-of-1 Learning Trajectory Profiles. Advanced Therapeutics. 2. 1900023. 10.1002/adtp.201900023
citation: Chin YC, Koh GC, Tay YK, Tan CH, Merchant RA. Underdiagnosis of delirium on admission and prediction of patients who will develop delirium during their inpatient stay: a pilot study. Singapore Med J. 2016 Jan;57(1):18-21. doi: 10.11622/smedj.2016007.