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| Name | Class |
|---|---|
| AIT Austrian Institute of Technology GmbH | OTHER |
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Heart failure patients within the HM programme
A prospective, randomized, multi-sectoral multi-centre study with parallel group design.
Application of guideline-directed medical therapy (GDMT) improves quality of life and decreases hospitalization for heart failure and mortality.
GDMT is in general underused. This also applies to patients who are cared for in the integrative, telemedicine-supported disease management program Herzmobil Tirol (HMT). The Assisted Therapy Optimizing Module has been designed to actively assist network physicians in adhering to and improving guideline-based medical therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMPEL group | Experimental | Network physicians participating in the study are randomly assigned to the AMPEL group (access to the module). |
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| non-AMPEL group | No Intervention | The non-AMPEL group (no access to the module) using a permuted block randomization scheme to ensure that there are the same number of patients in each study arm. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KITGuideMe: W61-MD41-AIT, version 1.0.0 | Device | We are planning to conduct a prospective, 1:1 randomized study within the HM program. Randomization occurs at the level of network physicians. Network physicians participating in the study are randomly assigned to either the AMPEL group (access to the module) or the non-AMPEL group (no access to the module) using a permuted block randomization scheme to ensure that there are the same number of patients in each study arm. Logical checks within the module ensure that once a network physician is assigned to an arm, he or she remains in that arm for the remainder of the stud |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Endpoints | The therapy optimization module improves guideline compliance within the framework of the Herzmobil care program individually optimized number and dose of GDMT 90 days after randomization based on the GDMT score. individually optimized number and dose of GDMT 90 days after randomization based on the GDMT score. | 09/2027 |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Endpoints | Increased guideline-based therapy will reduce mortality and rehospitalization rates. admissions vs. non-cardiovascular admissions) after 6 and 12 months | 09/2027 |
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Inclusion Criteria:
AMPEL, CIP, Version: 1.2 Date: 27.03.2024
Exclusion Criteria:
Male and female patients
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gerhard Poelzl, Prof. Dr. | Contact | +43 (0)50 504-25621 | gerhard.poelzl@tirol-kliniken.at | |
| Luca Brunelli, Dr. med. | Contact | +43 (0)50 504-83483 | luca.brunelli@i-med.ac.at |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Graz, University Hospital for Internal Medicine (Cardiology) | Recruiting | Graz | Styria | 8036 | Austria |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Medical University of Innsbruck, University Hospital for Internal Medicine III (Cardiology and Angiology) | Recruiting | Innsbruck | Tyrol | 6020 | Austria |
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