Efficacy of an Assisted Therapy Optimizing Module to Improve Physician Adherence
A Prospective Open Randomised Trial to Test the Efficacy of an Assisted Therapy
1 other identifier
interventional
234
1 country
2
Brief Summary
Heart failure patients within the HM programme
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable heart-failure
Started Dec 2024
Typical duration for not_applicable heart-failure
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 13, 2024
CompletedFirst Posted
Study publicly available on registry
December 3, 2024
CompletedStudy Start
First participant enrolled
December 3, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2027
February 19, 2025
November 1, 2024
2.8 years
November 13, 2024
February 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary Endpoints
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.
09/2027
Secondary Outcomes (1)
Secondary Endpoints
09/2027
Study Arms (2)
AMPEL group
EXPERIMENTALNetwork physicians participating in the study are randomly assigned to the AMPEL group (access to the module).
non-AMPEL group
NO INTERVENTIONThe 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.
Interventions
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
Eligibility Criteria
You may qualify if:
- AMPEL, CIP, Version: 1.2 Date: 27.03.2024
- 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
You may not qualify if:
- Multimorbidity (Charlson Comorbidity Index \> 6)
- Dementia
- Lack of willingness to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Medical University of Graz, University Hospital for Internal Medicine (Cardiology)
Graz, Styria, 8036, Austria
Medical University of Innsbruck, University Hospital for Internal Medicine III (Cardiology and Angiology)
Innsbruck, Tyrol, 6020, Austria
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 13, 2024
First Posted
December 3, 2024
Study Start
December 3, 2024
Primary Completion (Estimated)
September 30, 2027
Study Completion (Estimated)
September 30, 2027
Last Updated
February 19, 2025
Record last verified: 2024-11