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NCT Number: NCT06714344

Efficacy of an Assisted Therapy Optimizing Module to Improve Physician Adherence

Heart failure patients within the HM programme

Recruiting

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 criteria

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

Treatment and study plan

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

Primary outcomes

  1. Primary Endpoints

    Time frame: 09/2027

    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.

Secondary outcomes

  1. Secondary Endpoints

    Time frame: 09/2027

    Increased guideline-based therapy will reduce mortality and rehospitalization rates.

    admissions vs. non-cardiovascular admissions) after 6 and 12 months

Study contacts

Contact information is provided by the study sponsor or research team.

Gerhard Poelzl, Prof. Dr.

CONTACT

[email protected]

+43 (0)50 504-25621

Luca Brunelli, Dr. med.

CONTACT

[email protected]

+43 (0)50 504-83483

Sponsors and collaborators

Lead sponsor

Medical University Innsbruck

Other

Collaborators

  • AIT Austrian Institute of Technology GmbH

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Dec 3, 2024
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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