Efficacy of an Assisted Therapy Optimizing Module to Improve Physician Adherence

Medical University Innsbruck

Status: Enrolling

Conditions: Heart Failure

Treatments: Device: KITGuideMe: W61-MD41-AIT, version 1.0.0

Study type: Interventional

Funder types: Other

Identifiers

NCT06714344

AMPEL

Details and patient eligibility

About

Heart failure patients within the HM programme

Full 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.

Enrollment: 234 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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234 participants in 2 patient groups

AMPEL group

Experimental group

Description:

Network physicians participating in the study are randomly assigned to the AMPEL group (access to the module).

Treatment:

Device: KITGuideMe: W61-MD41-AIT, version 1.0.0

non-AMPEL group

No Intervention group

Description:

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.