Speakers
Daniel Pach, MD
Charité – Universitätsmedizin Berlin
Stefanie Lysk, MS
Charité – Universitätsmedizin Berlin
Newsenselab GmbH (app manufacturer)
Keywords
Decentralized Trial; App; Hybrid Care Model; Digital Tools
Key Points
- The 2019 Digital Healthcare Act enabled 73 million Germans in the statutory health insurance system to receive digital applications (AKA apps) on prescription. Apps may be prescribed by physicians and psychotherapists for specific diagnoses and integrated into a patient’s treatment plan.
- As a result, the Digital Health Application (DiGA) framework was established. The DiGA framework sets out several requirements: Apps must have a medical purpose, not aimed at primary prevention; must be certified as a medical device; and must demonstrate a positive healthcare effect. There are strict requirements regarding safety, data protection, quality, etc., and integration with hardware (e.g. wearables) is possible.
- From December 2020 to March 2022, EMMA – a remote, hybrid trial – was conducted to assess the effect of an app for migraine self-management on migraine days per month. The app included a headache and trigger diary; analysis; self-management techniques, including relaxation exercises, endurance training, and education; and heavier change techniques.
- The control arm used a diary-only app, with no capacity for feedback or analysis. Symptom intake was the same as the intervention group.
- Though both the control and intervention arms saw an average decrease of roughly 2 migraine days per month, the study team found that use of the app lent no added benefit over the diary-only control. Randomized clinical trials are essential to validate digital therapeutics, and the app was withdrawn from the DiGA directory.
- Learnings from EMMA were applied to a new project: the Menstrual Health and Hybrid Care Model for All Young Females (MeMaF). MeMaF has 2 stages: 1) digital self-care: evidence-based self-care instructions, symptom- and cycle-diary, knowledge content, and a medical device. 2) For eligible participants, 6 months of on-site and digital hybrid care: medical care, physiotherapy, nutritional counseling, health psychology sessions, additional app content, and telemedicine.
- The researchers concluded that sustainable care for complex chronic conditions will be hybrid, combining digital tools with active involvement of healthcare providers. Researchers need to understand hybrid care in real life and plan trials accordingly – though this increases complexity and demands on clinical trials.
Discussion Themes
The control app may have been too powerful; continuous data tracking may itself act as a powerful intervention.. The intervention app also had more entry points for data, so participants in the intervention arm may have been more likely to report symptoms.
There is a need for rigorous and well-designed control conditions. To ensure valid and interpretable study outcomes you need to understand your intervention well.
A post-hoc analysis of engagement with the app found that 85% of participants used the application on a daily basis. Specifically, they interacted with the trigger diaries and the analysis of their trigger factors; the self-care and self-management features of the application weren’t used as much, especially after the first 4 weeks. Dr. Pach noted that this is a common trend in digital studies.
Steps like user verification through insurance and a video consultation with a physician prevented fraudulent participation in the EMMA trial.