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

November 22, 2024 updated by: Heart and Diabetes Center North-Rhine Westfalia

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Bad Oeynhausen, Germany, 32545
        • Recruiting
        • Clinic for General and Interventional Cardiology/Angiology, Herz- und Diabeteszentrum NRW
        • Contact:
        • Contact:
          • Tanja K. Rudolph, MD
        • Contact:
          • Sara Waezsada, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Full access to a mobile App
Study patients will receive full access to a mobile App
Device: Application of App
Full Access to Mobile App
Other: Restricted access to a mobile App
Study patients will receive restricted access to a mobile App
Device: Application of App
Full Access to Mobile App

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heart and Diabetes Center North-Rhine Westfalia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 21, 2024

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

November 22, 2024

First Submitted That Met QC Criteria

November 22, 2024

First Posted (Estimated)

November 26, 2024

Study Record Updates

Last Update Posted (Estimated)

November 26, 2024

Last Update Submitted That Met QC Criteria

November 22, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HDZ-KA_023_TR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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