A Prescribed Digital Health App and Number of Migraine Days: A Randomized Clinical Trial
Abstract
IMPORTANCE: The digital therapeutics market is expanding rapidly, with growing patient adoption. In some countries, digital health applications are already prescribable, reshaping clinical practice.
OBJECTIVE: To compare the effectiveness of the prescribable digital health app used in this study with a control app in reducing the number of migraine days among adults diagnosed with migraine.
DESIGN, SETTING, AND PARTICIPANTS: This 2-arm, parallel-group randomized clinical trial was conducted remotely across Germany from March to December 2021. Adults (≥18 years of age) with episodic or chronic migraine were randomly assigned in a 1:1 ratio to the intervention (n = 238) using a prescribable digital health app, called M-sense Migräne, or to the control (n = 239) group. Data were analyzed from February to March 2022.
INTERVENTION: The intervention group used the full version of the prescribable digital health app, while the control group used an app version limited to headache diary features.
MAIN OUTCOMES AND MEASURES: The primary outcome was the number of migraine days per a 28-day month after 12 weeks of using the app (assessed weeks 9-12), analyzed using analysis of covariance adjusted for baseline migraine days and migraine type. Secondary outcomes included the number of headache days per month, quality of life (assessed with the 6-item Headache Impact Test), self-efficacy (assessed with the Headache Management Self-Efficacy Scale German Short Form), Headache-Attributed…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 477 participants or records.
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