Efficacy of an Assisted Therapy Optimizing Module to Improve Physician Adherence

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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06714344

Enrollment

234

Registered

2024-12-03

Start date

2024-12-03

Completion date

2027-09-30

Last updated

2025-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

Heart failure

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.

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Austria

Contacts

Primary ContactGerhard Poelzl, Prof. Dr.

gerhard.poelzl@tirol-kliniken.at+43 (0)50 504-25621

Backup ContactLuca Brunelli, Dr. med.

luca.brunelli@i-med.ac.at+43 (0)50 504-83483

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026