sinCephalea RCT study design published
The work to make sinCephalea part of the treatment landscape for migraine is continuing with a focused, long-term vision.
The core of this right now is the design of our RCT study. In this regard, there has been an important step. The paper outlining our RCT study design has been published.
Says Perfood CMO, Torsten Schröder, the protocol outlined in the paper is the “first systematic clinical trial with a fully digital program to enable patients with migraine to follow a personalized low-glycemic nutrition intervention.”
There are several other notable aspects to our RCT study design notes Torsten. Among them:
- This study is the first RCT with a completely digital nutrition program as prophylaxis of migraine and will bring valuable clinical data allowing confirmatory proof of the effectiveness of the DTx sinCephalea.
- DTxs usually involve complex interventions with multiple ‘active ingredients’, so a really blinded control app is often not feasible. Consequently, the current gold standard for DTx studies is designing the control group as a wait-list control into which the patients are randomized
- Digitally assessing the relevant outcomes has huge advantages: Patients can be reminded using app notifications, time stamps give information about the real timepoints of answering questionnaires, and in real-time the answers can be examined for consistency.
The threshold for permanent approval of a DiGA is extremely high. We embrace this challenge because the ultimate beneficiaries are patients, healthcare practitioners and the statutory health insurance system.
This RCT study design also underscores the value of strong research collaborations.
Says Torsten: “Proving the effectiveness of a DTx is not as straight forward as with medications. So, we worked hard — together with Professor Inke R. König and her team from the Institute of Medical Biometry and Statistics, University of Lübeck — to outline an appropriate study protocol, which addresses the obstacles that come along with an open-label lifestyle intervention study.”
Here is the link to the paper for the RCT study design that has just been published: https://doi.org/10.1186/s13063-022-06933-2
If you are interested in learning more about sinCephalea, please check out https://sincephalea.de.
Additionally, you can always reach out to Perfood CMO Torsten Schröder directly on LinkedIn. He is always happy to share what we are doing at Perfood.