Clinical trial NCT06647030: Personalized NFTs as a Trial Participation Incentive
Official title: 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 type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Healthy
Digital Health
Incentive Interventions
Keywords: Clinical Trials
Blockchain
Digital Therapeutics
DTx
Non-Fungible Tokens
NFTs
CURATE.AI
CURATE.DTx
AI-driven
Digital Avatar
Incentives
Patient Engagement
N-of-1
Single Participant
Lead sponsor: Institute for Digital Medicine (WisDM)
Sponsor class: OTHER
First posted: 2024-10-17
Enrollment: 15
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: NFTs are blockchain-based digital and physical assets traded on digital marketplaces. Current and exploratory NFT use cases include art, collectibles, in-game items, real estate, ticketing, events, fintech, licenses, IDs, and healthcare. NFT marketplaces, online games, virtual worlds, and open-source coding platforms use NFTs to incentivize participation. In trials, where the effectiveness of financial remuneration to increase trial participation is unclear, NFTs could encourage involvement. Considering the increasing opportunities for blockchain technology and NFT use in both the economy and society, we present a pilot study protocol to gauge the interest and feasibility of using NFTs as payment for trial participants, the first of its kind to our knowledge. Additionally, as the global population ages and chronic diseases become more prevalent, innovative solutions to sustain engagement in longevity-focused interventions are needed. Harnessing CURATE.AI, an indication-agnostic artificial intelligence (AI) platform that modulates the intensity of interventions to generate truly personalized profiles - or digital avatars, we will develop N-of-1 learning trajectory profiles for fifteen healthy volunteers trained on the CURATE.DTx, a digital therapeutic (DTx) platform. The profiles will be artistically modified and minted for the participants in the Ethereum blockchain, whereafter the recipient can choose to keep, display, or trade their NFT. Through interviews, we will evaluate the interest and acceptability of NFTs as an incentive for trial participation. This pioneering exploration connects AI-driven personalized medicine with inventive blockchain solutions. Our research aims to advance the field of digital therapeutics and pave the way for novel approaches to patient-centered care and incentivization strategies in clinical trials.


Eligibility criteria: 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

Primary outcomes:
measure: Interest and Acceptability of Personalized NFTs as Incentives
timeFrame: At week 11 into the trial (after the participant's last completed DTx session).
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: The Institute for Digital Medicine (WisDM)
name: Dean Ho, PhD
role: PRINCIPAL_INVESTIGATOR
References: