RecruitingNot ApplicableNCT06714344

Efficacy of an Assisted Therapy Optimizing Module to Improve Physician Adherence

A Prospective Open Randomised Trial to Test the Efficacy of an Assisted Therapy


Sponsor

Medical University Innsbruck

Enrollment

234 participants

Start Date

Dec 3, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Heart failure patients within the HM programme


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • AMPEL, CIP, Version: 1.2 Date: 27.03.2024
  • Written, signed and dated informed consent for inclusion in the HM programme
  • Male and female patients over 18 years of age.
  • Hospitalised for decompensated heart failure requiring intravenous diuretics
  • Need for iv diuresis in nonhospital setting because of impending hospitalization for cardiac decompensation

Exclusion Criteria3

  • Multimorbidity (Charlson Comorbidity Index \> 6)
  • Dementia
  • Lack of willingness to participate

Interventions

DEVICEKITGuideMe: W61-MD41-AIT, version 1.0.0

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


Locations(2)

Medical University of Graz, University Hospital for Internal Medicine (Cardiology)

Graz, Styria, Austria

Medical University of Innsbruck, University Hospital for Internal Medicine III (Cardiology and Angiology)

Innsbruck, Tyrol, Austria

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NCT06714344


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