Healthentia SaMD in Chronic Disease Management
Author Information
Author(s): Kyriazakos Sofoklis, Pnevmatikakis Aristodemos, Kostopoulou Konstantina, Ferrière Laurent, Thibaut Kyun, Giacobini Erika, Pastorino Roberta, Gorini Marco, Fenici Peter
Primary Institution: Innovation Sprint srl
Hypothesis
Can software as a medical device (SaMD) and mobile health (mHealth) applications improve health outcomes in chronic disease management?
Conclusion
The study shows that SaMD and mHealth applications can significantly enhance chronic disease management and improve health outcomes.
Supporting Evidence
- 24 studies (68.6%) focused on type 2 diabetes mellitus.
- Six studies (17.1%) focused on cardiovascular conditions.
- Three studies (8.7%) focused on cancer.
- One study (2.8%) focused on chronic obstructive pulmonary disease.
- One study (2.8%) focused on hypertension.
- No severe adverse events related to mHealth were reported.
- Five studies (14.3%) reported mild adverse events.
- Four studies (11.4%) reported technical issues with devices.
Takeaway
This study found that using health apps can help people with chronic diseases feel better and manage their health more effectively.
Methodology
The study involved a systematic literature review of clinical studies using the PICO model to assess the effectiveness of mHealth solutions in chronic disease management.
Potential Biases
Potential selection bias due to the limited scope of studies available for data collection.
Limitations
The study's methodology was limited to systematic reviews from a single database, which may introduce selection bias.
Participant Demographics
The study population comprised individuals afflicted by chronic diseases.
Digital Object Identifier (DOI)
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