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

NCT ID: NCT06706635

Last Updated: 2024-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-21

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Aortic Stenosis Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Full access to a mobile App

Study patients will receive full access to a mobile App

Group Type EXPERIMENTAL

Application of App

Intervention Type DEVICE

Full Access to Mobile App

Restricted access to a mobile App

Study patients will receive restricted access to a mobile App

Group Type OTHER

Application of App

Intervention Type DEVICE

Full Access to Mobile App

Interventions

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Application of App

Full Access to Mobile App

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heart and Diabetes Center North-Rhine Westfalia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinic for General and Interventional Cardiology/Angiology, Herz- und Diabeteszentrum NRW

Bad Oeynhausen, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Astrid Kleemeyer

Role: CONTACT

49 5731 971258

Facility Contacts

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Astrid Kleemeyer

Role: primary

+49 5731 971258

Tanja K. Rudolph, MD

Role: backup

Sara Waezsada, MD

Role: backup

Other Identifiers

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HDZ-KA_023_TR

Identifier Type: -

Identifier Source: org_study_id

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