CURATE.Dtx as a Diagnostic and Management Tool for Delirium

Exploring the Feasibility of Digital Intervention Games as a Diagnostic and Management Tool for Delirium at SGH Inpatient Wards

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Delirium
• Intervention / Treatment: Device: CURATE.Dtx; Device: Optional games

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Esther M Fan Peijin; Phone Number: +65 65762590; Email: esther.monica.fan.p.j@sgh.com.sg
• Study Contact Backup: Name: Marlena N Raczkowska, PhD; Phone Number: +6586615149; Email: marlena@nus.edu.sg

Study Locations

• Singapore
  • Singapore, Singapore, 168582
    • Singapore General Hospital
    • Contact: Singapore G Hospital; Phone Number: +6565762590; Email: esther.monica.fan.p.j@sgh.com.sg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Digital games; Each CURATE.DTx session will be 12 minutes long. 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.

Device: CURATE.Dtx; CURATE.Dtx is a self-guided digital multitasking game that involves a combination of four subtasks played simultaneously, targeting different cognitive domains.; Other Names: Delirium Screening Tool; Device: Optional games; The patient will first be asked how he/she feels and what they have done that day. The patient then selects a digital local pet (dog, cat, bird) and can customize its appearance, name and background location. The player can interact with their pet via several actions such as feed, bathe, train and accessorize. Playing with digital pets can help reduce stress and anxiety in the elderly. It can be a positive distraction in alleviating the elderly's worries and discomforts. In order to purchase accessories for their digital pet, they are encouraged to play short games that include Grocery Snap, Down Memory Lane and Pet Escape. These games are aimed at improving memory and reduce cognitive decline.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Acceptability	Patient survey on acceptability of CURATE.DTx and other digital games distributed prior to discharge or at the end of 5 days	30 minutes
Trial Team Members Acceptability	Trial team members survey on acceptability of CURATE.DTx and other digital games distributed at the end of the trial	30 minutes
Demand	Data collected during patient recruitment and throughout trial completion: a) Uptake : Percentage of successfully recruited patients from all patients approached and eligible for the study; b) Retention: Percentage of patients that complete the trial from all successfully recruited patients; c) Adherence: Percentage of completed sessions by patients at indicated timepoints	Throughout trial completion,up to 1 year
Implementation	Data collected throughout trial completion: a) Success of CURATE.DTx execution: Number of CURATE.DTx sessions successfully performed within this setting;	Throughout trial completion, up to 1 year
Practicality	Trial team members survey on practicality of CURATE.DTx and other games distributed at the end of the trial: a) Practicality: Trial team perception of the ability of patients to carry out the activities and their potential impact; b) Logistical feasibility: Logistical considerations with current trial protocol that would need to be addressed or accounted for a future RCT	30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usability	Patient survey distributed prior to discharge or at the end of 5 days on usability of CURATE.DTx	30 minutes

Collaborators and Investigators

• Sponsor: Institute for Digital Medicine (WisDM)
• Collaborators: Singapore General Hospital; National University of Singapore
• Investigators: Principal Investigator: Dean Ho, PhD, The Institute for Digital Medicine (WisDM); Principal Investigator: Esther M Fan Peijin, Singapore General Hospital

Publications and helpful links

General Publications

• 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
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2025
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: October 19, 2023
• First Submitted That Met QC Criteria: January 31, 2024
• First Posted (Actual): February 5, 2024

Study Record Updates

• Last Update Posted (Actual): August 27, 2024
• Last Update Submitted That Met QC Criteria: August 26, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: digital health; digital diagnostic
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium
• Other Study ID Numbers: WisDM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No