Efficacy of an Assisted Therapy Optimizing Module to Improve Physician Adherence

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

Heart failure patients within the HM programme

Study Overview

• Status: Recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Device: KITGuideMe: W61-MD41-AIT, version 1.0.0

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 234
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gerhard Poelzl, Prof. Dr.; Phone Number: +43 (0)50 504-25621; Email: gerhard.poelzl@tirol-kliniken.at
• Study Contact Backup: Name: Luca Brunelli, Dr. med.; Phone Number: +43 (0)50 504-83483; Email: luca.brunelli@i-med.ac.at

Study Locations

• Austria
  • Styria
    • Graz, Styria, Austria, 8036
      • Recruiting
      • Medical University of Graz, University Hospital for Internal Medicine (Cardiology)
      • Contact: Markus Wallner, Prof. Priv.-Doz. DDr.; Phone Number: +43 316 385 12544; Email: markus.wallner@medunigraz.at
  • Tyrol
    • Innsbruck, Tyrol, Austria, 6020
      • Recruiting
      • Medical University of Innsbruck, University Hospital for Internal Medicine III (Cardiology and Angiology)
      • Contact: Gerhard Poelzl, Prof. Dr.; Phone Number: +43 (0)50 504-25621; Email: gerhard.poelzl@tirol-kliniken.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

AMPEL, CIP, Version: 1.2 Date: 27.03.2024

1. Written, signed and dated informed consent for inclusion in the HM programme
2. Male and female patients over 18 years of age.
3. Hospitalised for decompensated heart failure requiring intravenous diuretics
4. Need for iv diuresis in nonhospital setting because of impending hospitalization for cardiac decompensation

Exclusion Criteria:

1. Multimorbidity (Charlson Comorbidity Index > 6)
2. Dementia
3. Lack of willingness to participate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AMPEL group; Network physicians participating in the study are randomly assigned to the AMPEL group (access to the module).	Device: KITGuideMe: 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
No Intervention: non-AMPEL group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Medical University Innsbruck
• Collaborators: AIT Austrian Institute of Technology GmbH

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2024
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: November 13, 2024
• First Submitted That Met QC Criteria: November 28, 2024
• First Posted (Actual): December 3, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 14, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Heart failure
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: AMPEL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No