Digital Health, Healthy, Incentive Interventions
Conditions
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
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.
Interventions
DEVICECURATE.DTx sessions
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.
BEHAVIORALInterview
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.
Sponsors
Institute for Digital Medicine (WisDM)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Interest and Acceptability of Personalized NFTs as Incentives | 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. |
Contacts
Primary ContactXavier Tadeo, PhD
Backup ContactPeter Wang, PhD
Outcome results
None listed