Background: Due to the widespread use of mobile devices like smart watches and smart phones, “mobile health”- (mhealth-) applications open up promising possibilities of biomedical data collection and telemedical care concepts. However, sufficient evidence on data quality and the clinical benefit of these mhealth-concepts is often missing.
Purpose: This abstracts presents the results of a pilot study testing a new telemedical care concept designed for patients with newly diagnosed heart failure.The trial analysed patient acceptance and feasibility of this specific mHealth approach. To evaluate the usability of activity data collected by mobile devices, a comparison of the device-related data with those of standardized clinical examinations was performed.
Materials and methods: The tested telemonitoring platform was designed for the combination of iPhone and Apple Watch. It comprises an active part for the patient that consists of daily input of relevant clinical data (blood pressure, bodyweight, symptoms, drug intake) into the iPhone App. The App has access to health-related data as heart frequency and daily steps that are measured passively during the day. All biomedical data are transferred continuously to the doctor in charge using encrypted connections.
In the present feasibility trial, the mHealth concept was tested over a period of two months in ten study participants who were hospitalized for newly diagnosed heart failure (LVEF ≤40%, NYHA ≥ II). For the duration of study, patients were provided an iPhone 6 SE as well as a first generation Apple Watch. At study inclusion as well as after one and two months, participants underwent the following examinations: transthoracic echocardiography, NTproBNP i.s., spiroergometry, questionnaires for heart failure and anxiety, 4 days Holter ECG, 6 minute walk test (6 MWT). A device-based 6 MWT was opposed to the standard 6 MWT.
Results: In questionnaires, the app received good values for usability and patient acceptance. Over the study period, the weekly average of daily steps showed a significant increase (2880 steps/day ± 2318 at study inclusion and 6095 steps/day ± 4158 at the end of study; p<0.0001) that correlated with an improvement of conventional parameters (LVEF in TTE, NT-proBNP, spiroergometry). The walking distance of the standard 6 MWT (578 m ± 166) didn't differ significantly from that of the device-related 6 MWT (vs. 520 m ± 111), but showed a strong correlation (r=0,929; p<0,001). A head-to-head comparison of heart frequency data measured by the Apple Watch with those of Holter ECGs will be presented.
Conclusion: Our pilot study shows that the developed mhealth- concept is suitable to telemonitor patients with heart failure. Device-collected activity data showed a strong correlation with conventional diagnostic parameters. Mhealth- applications may therefore be regarded as promising tools for telemedical care concepts and possible endpoints in clinical heart failure studies.