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临床试验/NCT06240897
NCT06240897Unknown不适用

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

Institute for Digital Medicine (WisDM)2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年2月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
20
试验地点
2
主要终点
Implementation

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Device Feasibility
盲法
None

入排标准

年龄范围
65 Years 至 99 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

结局指标

主要结局

Implementation

时间窗: Throughout trial completion, up to 1 year

Data collected throughout trial completion: a) Success of CURATE.DTx execution: Number of CURATE.DTx sessions successfully performed within this setting;

Practicality

时间窗: 30 minutes

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

Demand

时间窗: Throughout trial completion,up to 1 year

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

Trial Team Members Acceptability

时间窗: 30 minutes

Trial team members survey on acceptability of CURATE.DTx and other digital games distributed at the end of the trial

Patient Acceptability

时间窗: 30 minutes

Patient survey on acceptability of CURATE.DTx and other digital games distributed prior to discharge or at the end of 5 days

次要结局

  • Usability(30 minutes)

研究者

发起方
Institute for Digital Medicine (WisDM)
申办方类型
Other
责任方
Sponsor

研究点 (2)

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