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

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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06706635

Acronym

TAVI-SDM-APP

Enrollment

250

Registered

2024-11-26

Start date

2024-08-21

Completion date

2025-12-31

Last updated

2024-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Stenosis Disease

Keywords

aortic stenosis, mobile app

Brief summary

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

DEVICEApplication of App

Full Access to Mobile App

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Germany

Contacts

Primary ContactAstrid Kleemeyer

akleemeyer@hdz-nrw.de49 5731 971258

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026