ABSTRACT
BACKGROUND: User engagement is crucial for digital therapeutics (DTx) effectiveness; due to variations in the conceptualization of engagement and intervention design, assessment and retention of engagement remain challenging. OBJECTIVE: We investigated the influence of the perceived acceptability of experimental intervention components and satisfaction with core intervention components in DTx on user engagement, while also identifying potential barriers and facilitators to user engagement. METHODS: We conducted a mixed methods study with a 2 × 2 factorial design, involving 12 outpatients with atopic dermatitis. Participants were randomized into 4 experimental groups based on push notification ("basic" or "advanced") and human coach ("on" or "off") experimental intervention components. All participants engaged in self-monitoring and learning courses as core intervention components within an app-based intervention over 8 weeks. Data were collected through in-app behavioral data, physician- and self-reported questionnaires, and semistructured interviews assessed at baseline, 4 weeks, and 8 weeks. Descriptive statistics and thematic analysis were used to evaluate user engagement, perceived acceptability of experimental intervention components (ie, push notification and human coach), satisfaction with core intervention components (ie, self-monitoring and learning courses), and intervention effectiveness through clinical outcomes. RESULTS: The primary outcome indicated that group 4, provided with "advanced-level push notifications" and a "human coach," showed higher completion rates for self-monitoring forms and learning courses compared to the predetermined threshold of clinical significance. Qualitative data analysis revealed three key themes: (1) perceived acceptability of the experimental intervention components, (2) satisfaction with the core intervention components, and (3) suggestions for improvement in the overall intervention program. Regarding clinical outcomes, the Perceived Stress Scale and Dermatology Life Quality Index scores presented the highest improvement in group 4. CONCLUSIONS: These findings will help refine the intervention and inform the design of a subsequent randomized trial to test its effectiveness. Furthermore, this design may serve as a model for broadly examining and optimizing overall engagement in DTx and for future investigation into the complex relationship between engagement and clinical outcomes. TRIAL REGISTRATION: Clinical Research Information Service KCT0007675; http://tinyurl.com/2m8rjrmv.
ABSTRACT
PURPOSE: This study was conducted to build a direction for government policies regarding strategies for the commercialization of digital therapeutics in Korea, as well as its globalization. MATERIALS AND METHODS: The study included 37 participants from the Korea Digital Health Industry Association (KODHIA). The data was based on a survey conducted in 2020 targeting employees of companies engaged in the digital health industry in Korea. Participants were asked about their involvement in product development of digital therapeutics and their opinion about the growing motivator for digital therapeutics in Korea and the global market. RESULTS: According to our data, among subjects not involved in making digital therapeutics products, the main reason for not being involved was the lack of experts (73.9%) and difficulty in licensing (73.9%). Responses concerning the priority area in need of national support were R&D funding (43.2%), and the next was licensing guidance and simplifying regulations (24.3%). Possible difficulties of overseas market expansion were the unfamiliarity in digital therapeutics technology verification and licensing structures of foreign countries (73%), and concerns regarding the level of recognition of clinical trials and technology in Korea from overseas (70.3%). Overall, respondents were hesitant in starting a related business due to the lack of government support and the complexity of the regulation process. Moreover, concerns about global market entry were similar. Being unfamiliar with the novel process and worrying about the achievement despite existing challenges were the biggest drawback. CONCLUSION: For the digital therapeutics industry to evolve domestically and internationally, government support and guidance are essential.
