DeliriumNCT06240897
CURATE.Dtx as a Diagnostic and Management Tool for Delirium
A study testing CURATE.Dtx and Optional games in people with Delirium, run by Institute for Digital Medicine (WisDM) at 1 site in Singapore.
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… Read more about this study
- Who is it for?
- Ages 65 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Delirium
- What is being tested?
- CURATE.Dtx and Optional games
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSingapore
- Study dates
- Feb 2025to Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 99 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Admitted to the medical ward in SGH
- Age >=65 years old
- Patients with a life expectancy of at least 1 month
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Singapore1 site
Singapore General Hospital
Singapore, 168582
Singapore G Hospital, +6565762590, esther.monica.fan.p.j@sgh.com.sg
About this study
Official title: 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.
Read the 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.
- Conditions
- Delirium
- Being tested
- CURATE.Dtx, Optional games
- Keywords
- digital health, digital diagnostic
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CURATE.DtxDevice
Also called Delirium Screening Tool
CURATE.Dtx is a self-guided digital multitasking game that involves a combination of four subtasks played simultaneously, targeting different cognitive domains.
Optional gamesDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: CURATE.Dtx; Device: Optional games |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Acceptability
Patient survey on acceptability of CURATE.DTx and other digital games distributed prior to discharge or at the end of 5 days
Measured: 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
Measured: 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
Measured: 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;
Measured: 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
Measured: 30 minutes
Secondary outcomes (1)
Usability
Patient survey distributed prior to discharge or at the end of 5 days on usability of CURATE.DTx
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study startFeb 2025 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute for Digital Medicine (WisDM)
- Sponsor type
- University, hospital or other
- Collaborators
- Singapore General Hospital, National University of Singapore
- Responsible party
- Sponsor
- Investigators
- Dean Ho, PhD, Principal investigator, The Institute for Digital Medicine (WisDM)Esther M Fan Peijin, Principal investigator, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06240897
- Sponsor's protocol ID
- WisDM
- Status last verified
- Jan 2024
- First submitted
- 19 Oct 2023
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 26831312
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Feasibility of Digital Intervention Games as a Diagnostic and Management Tool for Delirium at SGH Inpatient Wards
- ClinicalTrials.gov ID
- NCT06240897
- Acronym / sponsor ID
- WisDM
- Conditions
- Delirium
- Keywords
- digital health, digital diagnostic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Institute for Digital Medicine (WisDM)University, hospital or other
- Collaborators
- Singapore General Hospital, National University of Singapore
- Study start
- Feb 2025 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 5 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Digital games | Experimental | Device: CURATE.Dtx, Device: Optional gamesEach 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. |
Who may qualify
- Ages
- 65 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Admitted to the medical ward in SGH
- Age >=65 years old
- Patients with a life expectancy of at least 1 month
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CURATE.DtxAlso: Delirium Screening ToolCURATE.Dtx is a self-guided digital multitasking game that involves a combination of four subtasks played simultaneously, targeting different cognitive domains. | Device | Digital games |
| Optional gamesThe 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. | Device | Digital games |
Primary outcome
Patient Acceptability
Time frame: 30 minutes
Patient survey on acceptability of CURATE.DTx and other digital games distributed prior to discharge or at the end of 5 days
Trial Team Members Acceptability
Time frame: 30 minutes
Trial team members survey on acceptability of CURATE.DTx and other digital games distributed at the end of the trial
Demand
Time frame: 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
Implementation
Time frame: 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
Time frame: 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
1 secondary outcome
Usability
Time frame: 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- BackgroundKee, 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: PubMed 26831312Chin 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.
- Individual participant dataSharing planned: No
Related trials for Delirium
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
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Prediction and Prevention of Postoperative Mortality and Morbidity
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DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial)
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RecruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
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Not yet recruitingObservational study
Comparison of IV Dexmedetomidine Versus Clonidine Versus no Alpha 2 Agonist on Emergency Delirium, PACU Length of Stay and Time to Hospital Discharge in Children Undergoing (Adeno)Tonsillectomy: a Prospective Observational Study
Emergency Delirium, Postoperative Delirium (POD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dean Ho, PhD principal investigator
The Institute for Digital Medicine (WisDM)
Esther M Fan Peijin principal investigator
Singapore General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CURATE.Dtx and Optional games in people with Delirium, run by Institute for Digital Medicine (WisDM) at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Esther M Fan Peijin (+65 65762590, esther.monica.fan.p.j@sgh.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Acceptability (time frame: 30 minutes). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06240897, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2024.