- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06647030
Personalized NFTs as a Trial Participation Incentive (AvatarDTx)
A Pilot Study on the Use of Personalised Non-Fungible Token (NFT) Artwork Generated From Digital Therapeutics (DTx) as a Trial Participation Incentive (Avatar.DTx)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Xavier Tadeo, PhD
- Phone Number: +65 6601 7766
- Email: lsixtc@nus.edu.sg
Study Contact Backup
- Name: Peter Wang, PhD
- Phone Number: +65 6601 7766
- Email: lsipww@nus.edu.sg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Healthy
- Agree to audio-recording of the interview
- Meet the cognitive criteria for adequate mental capacity as determined by the MMSE.
Exclusion Criteria:
- Difficulty to understand and read English (the DTx text and audio are in English)
- Significant hearing impairment
- Evidence/diagnosis of severe cognitive impairment
- Inability to complete the study at the judgement of the investigators
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Avatar.DTx
DTx sessions: participants will interact with the DTx twelve minutes per day, three days per week, for ten weeks.
We will obtain a personalized profile for each participant (relationship between training intensity and participant's performance).
A digital artist will receive the profiles without personal or medical data and create fifteen unique artworks.
The team, who will mint the artworks as NFTs on Ethereum and send them to the participants' digital wallets (or help them to set one up).
The NFTs will be displayed on OpenSea.
If the Ethereum blockchain stops its activity within two years of the NFT minting, the team will mint a new NFT for each participant in an alternative blockchain and compensate them with SGD150.
After the last DTx session (regardless of study completion by the participant), a 60-minute interview will be conducted.
|
Participants will interact with CURATE.DTx twelve minutes per day, three days a week, for ten weeks. CURATE.DTx is a cognitive training DTx developed by our research team in The N.1 Institute for Health (N.1) and The Institute for Digital Medicine (WisDM). CURATE.DTx is comprised of CURATE.AI and a modified version of the Multi-Attribute Task Battery (MATB), Online MATB. CURATE.AI is a small data AI-derived platform that can dynamically personalize treatment by modulating drug dose or therapy intensity. We previously implemented CURATE.AI into Online MATB - the modernized, online version of MATB, a flight deck simulator program developed by NASA and the United States Air Force.
After the last DTx session (regardless of study completion by the participant), a 60-minute interview session will be conducted by a team member, either at the Institute for Digital Medicine (WisDM) in person or via Zoom.
All responses will be audio-recorded and transcribed verbatim.
We will use thematic analysis of anonymized transcripts to identify emerging or recurring themes.
Data will be analyzed using NVivo.
The analysis will begin with open/primary coding, where we will descriptively label data.
Subsequently, we will group the labels into categories based on literature (i.e., secondary coding).
These categories will then help create broader themes/assertions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Interest and Acceptability of Personalized NFTs as Incentives
Time Frame: At week 11 into the trial (after the participant's last completed DTx session).
|
Evaluated through semi-structured interviews conducted at the end of the study.
|
At week 11 into the trial (after the participant's last completed DTx session).
|
Collaborators and Investigators
Investigators
- Principal Investigator: Dean Ho, PhD, The Institute for Digital Medicine (WisDM)
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Avatar.DTx
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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