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| Name | Class |
|---|---|
| Federal Ministry of Health, Germany | OTHER_GOV |
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The MobiDig trial is designed to evaluate an implementation of a mobile phone application with secondary preventive/rehabilitative modules for patients with heart failure in certified Heart Failure Unit centers in Berlin and Brandenburg.
The aim is to evaluate the effect on quality of life, symptoms and the course of the disease. In addition, the acceptance, adherence and user behavior as well as the implementation potential for a permanent introduction of the application in national heart failure networks will be analyzed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MobiDig | Other | 50 patients will have access to a mobile phone application for 3 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MobiDig | Other | The application will contain the following modules:
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| Measure | Description | Time Frame |
|---|---|---|
| Acceptance of the application | The acceptence of the application will be measured by the User Experience Questionnaire. It consists of 9 items that can be rated on a 7-point Likert scale. -3 (fully agree with negative term) to +3 (fully agree with positive term). A higher total score means a better outcome. | 3 months |
| Change in quality of life | Quality of life measured by Kansas City Cardiomyopathy Questionnaire using the validated 12-item version which has been described by Spertus et Jones (doi: 10.1161/CIRCOUTCOMES.115.001958.) A higher score means a better outcome. | Baseline and 3 months |
| Patient reported outcomes | Health-related quality of life will be measured by the "Patient Related Outcome and Measurement Information System" (PROMIS) test. Including 23 items that will be analyzed via Likert scale 1 (impossible/never) to 5 (no limitations/very good). A higher score means a better outcome. | Baseline and 3 months |
| Change in symptoms of heart failure | Symptoms of heart failure will be assessed by the New York Heart Association functional class. Consisting of four classes (I-IV), the higher, the worse the outcome. | Baseline and 3 months |
| Change in six-minute walk distance | Functional capacity will be assessed by the 6-minute walk test | Baseline and 3 months |
| Change in daily walking distances | Functional capacity will be assessed by the steps taken within 24 hours (pedometry). | Baseline and 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Isabell A Just, Dr. | Contact | 00493045932025 | ijust@dhzb.de | |
| Felix Schoenrath, Prof. Dr. | Contact | 00493045932085 | schoenrath@dhzb.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Deutsches Herzzentrum der Charité - Universitätsmedizin Berlin | Recruiting | Berlin | Deutschland | 13353 | Germany |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Change in heart failure biomarker | Heart failure severity will be assessed by the biomarker NT-proBNP. | Baseline and 3 months |
| Number of hospitalizations | Number of hospitalizations for heart failure will be assessed. | 3 months |
| Length of hospitalizations | Length of in-hospital stay of hospitalizations for heart failure will be assessed. | 3 months |
| Charité - Universitätsmedizin Berlin: Campus Virchow-Klinikum | Recruiting | Berlin | 13353 | Germany |
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| Herzzentrum Berlin | Active, not recruiting | Bernau | Germany |