CURATE.Dtx as a Diagnostic and Management Tool for Delirium

Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06240897
• Other study ID #: WisDM
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2024
• Est. completion date: April 2024

Study information

• Verified date: January 2024
• Source: Institute for Digital Medicine (WisDM)
• Contact: Esther M Fan Peijin
• Phone: +65 65762590
• Email: esther.monica.fan.p.j[@]sgh.com.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: April 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Delirium

Intervention

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.
• 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.

Locations

Country	Name	City	State
Singapore	Singapore General Hospital	Singapore

Sponsors (3)

Lead Sponsor	Collaborator
Institute for Digital Medicine (WisDM)	National University of Singapore, Singapore General Hospital

Country where clinical trial is conducted

Singapore, 

References & Publications (2)

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. — View 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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Usability	Patient survey distributed prior to discharge or at the end of 5 days on usability of CURATE.DTx	30 minutes