Efficacy of an Assisted Therapy Optimizing Module to Improve Physician Adherence

Not Applicable

Recruiting

• Conditions: Heart Failure

• Registration Number: NCT06714344
• Lead Sponsor: Medical University Innsbruck

Brief Summary

Heart failure patients within the HM programme

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 Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-13
• Study First Submitted QC: 2024-11-28
• Study Start: 2024-12-03
• Study First Posted: 2024-12-03
• Last Update Submitted: 2025-02-14
• Last Update Posted: 2025-02-19
• Primary Completion: 2027-09-30
• Study Completion: 2027-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 234

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Primary Endpoints	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 Outcome Measures

Name	Time	Method
Secondary Endpoints	09/2027	Increased guideline-based therapy will reduce mortality and rehospitalization rates.; admissions vs. non-cardiovascular admissions) after 6 and 12 months

Trial Locations

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