The ProCarement App ProHeart is a software application designed for use on mobile devices by patients and users with heart failure (I50ff). The application supports users with disease-specific information based on their individual conditions. Therefore, disease-specific vital signs and conditions are recorded and displayed in the app. The transmission of vital signs (such as heart rate, blood pressure, oxygen saturation, weight, body temperature) can be transmitted via a secure Bluetooth connection from certified Bluetooth devices. The app is explicitly not intended to provide a diagnosis.
Intended purpose and (other) intended use
Medical purpose
The app aims to improve users' health status, quality of life, and disease-specific knowledge. Disease-specific knowledge and adherence to therapy are promoted. Therefore, warning signs and deviations from health status can be detected at an early stage. Through the app, behavioral changes are promoted as well as the sovereignty of the user.
Disease-specific information is recorded regularly and displayed to the user in an easy-to-understand form. In addition, patients are reminded daily to take their medication and are regularly asked about their well-being. Based on this information and the individual health and therapy profile, specially prepared medical information is sent to the user. This includes information on health status, specific symptoms and treatment. This is supplemented by information on nutrition, exercise and other everyday topics conveyed through pop-ups and messages. On the one hand, this leads to an adjustment of the individual health-related behavior, on the other hand, it supports the early detection of decompensations and other deteriorations of the health status. All information can be exported by the user and transmitted to the doctor, which creates transparency about the health status and treatment over the selected period of time. This kind of feedback loops train the patient and let him participate more actively in his own health management.
Indications
| Indication | ICD-10 |
|---|---|
| Heart failure | I50ff |
Contra-indications and exclusions
| Contraindication | ICD-10 |
|---|---|
| Pregnancy and lactation | |
| Children, minors under 18 | |
| Chronic kidney disease, stage 5 | N18.5 |
Other intended use
Other purposes
Customized health management
- Reminder to measure vital signs
- Reminder to take medication
- Reminder to follow the treatment plan
- Reminder for daily weight measurement
- Recording of the individual well-being
- Acquisition and display of vital signs in a format that can be understood by the patient
- Possibility to enter diagnoses
- Possibility to enter a medication plan
Individualized health coaching
- Visualization of health parameters
- Guidance on the correct interpretation of vital signs
- Medical information
- Motivation through visualization of success metrics, such as therapy adherence
- Providing disease-specific information: educational purpose.
- Pop-up information: knowledge acquisition about pathology, diagnosis and therapy on a daily basis.
Risk prevention
- Support with the coordination of appointments
- Adjustment of the threshold values of the vital parameters and scores by the attending physician (however, application also works without this input)
- Information on important rules of conduct for critical values
- Patient receives a notification in case of deviating vital values
- "Emergency passport"
- Document management
- Collecting medical documents in the archive
- Provision of documents, reporting to physicians
Non-medical purposes
Service
- Technical support is available in case of problems or difficulties
Connection with other devices, systems, (medical) products, accessories
- Bluetooth transmission of vital parameters to the app is possible by integrating interfaces to common wearables
- List of wearables see below
Update, Upgrade
- For new features, patients are notified that updates are available and can be installed via the Google Play Store and the Apple App Store, where the app can be downloaded
Installation
- The installation is done via a download from the Google Play Store or the Apple App Store
Configuration, parameterization
- A configuration can either be performed by the patient himself as soon as the app is started for the first time or by the physician, who can alternatively onboard the patient
Disposal
- The app can be uninstalled
User characterization
Primary users
| User | Characterization |
|---|---|
| Patient | Typical tasks in the context of the medical device: - Daily recording of vital signs with medical devices and wearables Linguistic and intellectual skills: - German Level B2 General IT Experience: - advantageous, but not mandatory Training: - training by ProCarement is necessary Indication: - Heart failure I50ff Body parts that are treated, examined or monitored: - Heart rate - Oxygen saturation - Body temperature - Weight - Blood pressure Contraindications: - Pregnancy, lactation - Children, minors under 18 - Chronic kidney disease, stage 5, N18.5 Demographics: - all patients from 18 years Warning: - ProHeart does not replace medical examination, diagnosis and treatment/therapy |
Secondary users/Indirect users
| User | Characterization |
|---|---|
| Doctors | Education, training, degrees: - certified physician Typical tasks in the context of the medical device: - Possibility of onboarding the patient - Prescribe the DiGA - Possibility of patient interaction and therapy design Linguistic and intellectual abilities - Understanding the DiGA - German B2 General IT Experience: - Advantageous, but not mandatory Training: - training by ProCarement is necessary |
Characterization of the patients
| User | Characterization |
|---|---|
| Patient | Typical tasks in the context of the medical device: - Daily recording of vital signs with medical devices and wearables Linguistic and intellectual skills: - German Level B2 General IT Experience: - advantageous, but not mandatory Training: - training by ProCarement is necessary Indication: - Heart failure I50ff Body parts that are treated, examined or monitored: - Heart rate - Oxygen saturation - Body temperature - Weight - Blood pressure Contraindications: - Pregnancy, lactation - Children, minors under 18 - Chronic kidney disease, stage 5, N18.5 Demographics: - all patients from 18 years Warning: - ProHeart does not replace medical examination, diagnosis and treatment/therapy |
Characterization of the context of use
General environment
The application is usually used in the home environment:
- Home Healthcare
Supply technology
IT environment
- Hardware (minimum requirements): common devices (e.g. current smartphone, tablet PC)
- Operating system (type, versions): iOS, Android
- stable internet connection
- Bluetooth enabled device
Portability
The medical device is not location-bound, only hardware-bound, as it is software.
Usage note
The ProHerz app can be used at any time when the patient needs it. For optimal risk profiling, daily use is recommended but not a requirement.
Claims
Medical Claims
ProHeart allows patients to create risk profiles based on their medical information. The calculated risk profiles provide patients with information about the likelihood of their condition worsening and the likelihood of developing additional diseases. ProHeart notifies patients of abnormal values in their medical profile and instructs them to contact their physician. The application improves the patient's quality of life and health status.
Non-medical claims
Patient record:
ProHeart allows the user to store and retrieve medical profile information. The profile parameters can be entered directly by the patient and the physician or automatically imported from compatible medical devices.
Therapy Management:
ProHeart enables physicians to digitally create and modify therapy plans (including medication, tasks, etc.) and make them available to patients remotely.
ProHeart provides patients and their physicians with digital access to the patient's past and current diagnoses and treatment plans (including medications, exercises, tasks, scheduled exams and checkups, etc.).
Communication, scheduler and reminder:
ProHeart allows to send messages to the patient. ProHeart allows the doctor to set reminders for the patient about check-ups and other medical appointments. A learning function is built into the application to improve knowledge about the disease with daily learning sessions. ProHeart improves the patient's health literacy. This enables the patient to help shape and make decisions about their therapy. Ultimately, it improves compliance and adherence to therapy.