Background
A pharmaceutical manufacturer was planning to use a smartphone app in a clinical trial. The app consisted of several tests to assess specific disease symptoms.
The data captured via the app would help assess changes of patients’ abilities and therefore potentially assess the effectiveness of the treatment.
To ensure usability of the app and if it would capture appropriate data , it had to be tested with patients prior to launch.
Approach
We recruited 20 patients diagnosed with different stages of a neurodegenerative disease.
During face-to-face interviews, patients were asked to use the smartphone app and its “games”.
For some sessions, alternative versions (e.g., with several difficulty levels, or different parameters) were tested to identify the best design and/or baseline settings.
Outcome
The research revealed several usability issues with the app. Additionally, we showed that some of the instructions were not understood by all participants and could be a source of confusion.
Based on these results, uintent provided recommendations for the manufacturer to address before the app’s launch in the clinical trial.
Method
Formative usability test, Health app testing
Duration
3 months
Healthcare
Validating a Digital Biomarker App for Clinical Trials
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