Menu
Recruiting NCT06706635

Impact of Enhanced Information on Subjective Information Level and PROMs in Patients with Aortic Stenosis

No phase Interventional Aortic Stenosis Disease

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: Application of App.
Who it may be relevant to
Registry conditions: Aortic Stenosis Disease. 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
Germany
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

Impact of Enhanced Information Provision by Using a Mobile App on Subjective Information Level As the Basis for Shared-decision Making and Patient-reported Outcome Measures (PROMs) in Patients with Aortic Stenosis

Overview

The aim of this trial is to evaluate if an enhanced information by using a mobile App can increase subjective information level in patients with severe aortic stenosis and may therefore improve patient-reported outcomes.

Interventions

  • Device Application of App
    Full Access to Mobile App

Primary outcome measures

  • Subjective information level (EORTC QOL-INFO 25 questionnaire) [Time frame: From enrollment to the end of FU at 3 months]

Eligibility criteria

Inclusion criteria

  • severe aortic valve stenosis
  • planned aortic valve replacement (TAVI)
  • Patient is willing and able to complete the surveys in German language
  • Written informed consent by the trial subject

Exclusion criteria

\- Language barrier

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

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Germany · 1 center
  • Clinic for General and Interventional Cardiology/Angiology, Herz- und Diabeteszentrum NRW — Bad Oeynhausen

Identifiers

NCT: NCT06706635 · HDZ-KA_023_TR

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗