CURATE.Dtx as a Diagnostic and Management Tool for Delirium

NCT06240897 | Not Yet Recruiting

• 1 other identifier: WisDM
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium

Keywords

digital health; digital diagnostic

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Usability

  30 minutes

Study Arms (1)

Digital games

EXPERIMENTAL

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; Device: Optional games

Interventions

CURATE.Dtx DEVICE

CURATE.Dtx is a self-guided digital multitasking game that involves a combination of four subtasks played simultaneously, targeting different cognitive domains.

Also known as: Delirium Screening Tool

Digital games

Optional games DEVICE

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.

Digital games

Eligibility Criteria

• Age: 65 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute for Digital Medicine (WisDM): lead
• Singapore General Hospital: collaborator
• National University of Singapore: collaborator

Study Sites (1)

Singapore General Hospital

Singapore, 168582, Singapore

Location

Related Publications (2)

• 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

  BACKGROUND

• 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.

  PMID: 26831312 BACKGROUND

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

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

Study Officials

• Dean Ho, PhD

  The Institute for Digital Medicine (WisDM)

  PRINCIPAL INVESTIGATOR

• Esther M Fan Peijin

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Esther M Fan Peijin

CONTACT

+65 65762590; esther.monica.fan.p.j@sgh.com.sg

Marlena N Raczkowska, PhD

CONTACT

+6586615149; marlena@nus.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2023
• First Posted: February 5, 2024
• Study Start: February 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: April 1, 2026
• Last Updated: August 27, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)