TY  - JOUR
AU  - Lee, Hyerim
AU  - Choi, Eung Ho
AU  - Shin, Jung U
AU  - Kim, Tae-Gyun
AU  - Oh, Jooyoung
AU  - Shin, Bokyoung
AU  - Sim, Jung Yeon
AU  - Shin, Jaeyong
AU  - Kim, Meelim
PY  - 2024
DA  - 2024/2/9
TI  - The Impact of Intervention Design on User Engagement in Digital Therapeutics Research: Factorial Experiment With a Mixed Methods Study
JO  - JMIR Form Res
SP  - e51225
VL  - 8
KW  - atopic
KW  - dermatitis
KW  - experimental design
KW  - mobile health
KW  - patient engagement
KW  - research methodology
AB  - 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 
SN  - 2561-326X
UR  - https://formative.jmir.org/2024/1/e51225
UR  - https://doi.org/10.2196/51225
UR  - http://www.ncbi.nlm.nih.gov/pubmed/38335015
DO  - 10.2196/51225
ID  - info:doi/10.2196/51225
ER  -