JMIR Publications

ABSTRACT

Background:

Mobile device-enabled interventions known as digital therapeutics (DTx) are increasingly used to prevent chronic disease by targeting psychological and behavioral processes. Individuals’ unique experiences while receiving DTx comprise real-world evidence (RWE) for evaluating DTx performance. The current study applied the DTx RWE Framework to formatively evaluate a novel DTx (the eMOTION Study) to enhance affective response (i.e., how people feel) during physical activity (PA).

Objective:

We sought to determine whether the eMOTION DTx met a priori benchmarks for safety, efficacy, accessibility/usability, sustainability/feasibility, and equity.

Methods:

Participants (N=36, Mage=46 [SD=14], 53% female) underwent stratified random assignment to test one of four DTx versions for 14-days (n=9 each): (1) intensity PA goals; (2) affect PA goals with type/context recommendations; (3) affect PA goals with savoring exercises; and (4) affect PA goals with type/context and savoring. Participants completed daily intervention sessions asking them to focus on achieving a target heart rate (intensity) or feeling good (affect) during PA. Smartwatches were used to track PA and answer ecological momentary assessment (EMA) about how they felt during PA. Performance toward benchmarks was primarily assessed with questionnaires, interviews, and EMA.

Results:

The eMOTION DTx versions exceeded all a priori safety, efficacy, accessibility/usability, sustainability/feasibility, and equity thresholds. For safety, no adverse events were reported. Regarding efficacy, over half of participants who received affect goals reported increased PA enjoyment at the end of the study, and post-hoc multilevel models of EMA data revealed that the affect (vs. intensity) groups had significantly greater “positive” affective responses during PA (Ps= .02 to .04; Cohen’s ds= 0.63 to 0.67). Moreover, 64-72% of participants rated the DTx at or above the standard System Usability Scale cut-point for acceptable accessibility/usability. More than 60% of participants reported satisfaction with all DTx components, supporting DTx sustainability/feasibility. Finally, there was evidence for equity, with efficacy and accessibility comparable across sex, race, ethnicity, income, age, BMI, mobility, and physical constraint sub-groups.

Conclusions:

DTx RWE Framework benchmarks indicated that the eMOTION Study DTx is ready for a full-scale effectiveness trial to refine the DTx to optimize efficiency and feasibility. Our approach incorporated transparent decision-making to generate results that are more readily-translatable, easily replicable, and reflect current best practices in the field of DTx. Clinical Trial: This project was registered on ClinicalTrials.gov (ID: NCT06125964) and Open Science Framework (DOI: 10.17605/OSF.IO/QTF79).