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Recruiting NCT06714344

Efficacy of an Assisted Therapy Optimizing Module to Improve Physician Adherence

No phase Interventional Heart Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: KITGuideMe: W61-MD41-AIT, version 1.0.0.
Who it may be relevant to
Registry conditions: Heart Failure. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Austria
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • 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 a

Primary outcome measures

  • Primary Endpoints [Time frame: 09/2027]
Secondary outcome measures (1)
  • Secondary Endpoints [Time frame: 09/2027]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Health services research

Study locations

Austria · 2 centers
  • Medical University of Graz, University Hospital for Internal Medicine (Cardiology) — Graz
  • Medical University of Innsbruck, University Hospital for Internal Medicine III (Cardiology — Innsbruck

Identifiers

NCT: NCT06714344 · AMPEL

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗