NCT06714344

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 234 (estimated)
• Sponsor: Medical University Innsbruck · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Heart Failure

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-12-03
• Primary completion: 2027-09-30
• Completion: 2027-09-30
• First posted: 2024-12-03
• Last updated: 2025-02-19

Locations

2 sites across 1 country: Austria