Impact of Enhanced Information on Subjective Information Level and PROMs in Patients with Aortic Stenosis (TAVI-SDM-APP)

Heart and Diabetes Center North-Rhine Westfalia

Status: Enrolling

Conditions: Aortic Stenosis Disease

Treatments: Device: Application of App

Study type: Interventional

Funder types: Other

Identifiers

NCT06706635

HDZ-KA_023_TR

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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250 participants in 2 patient groups

Full access to a mobile App

Experimental group

Description:

Study patients will receive full access to a mobile App

Treatment:

Device: Application of App

Restricted access to a mobile App

Other group

Description:

Study patients will receive restricted access to a mobile App

Treatment:

Device: Application of App