NCT06706635

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 21, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 26, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

November 26, 2024

Status Verified

November 1, 2024

Enrollment Period

12 months

First QC Date

November 22, 2024

Last Update Submit

November 22, 2024

Conditions

Aortic Stenosis Disease

Keywords

aortic stenosismobile app

Outcome Measures

Primary Outcomes (1)

  • Subjective information level (EORTC QOL-INFO 25 questionnaire)

    From enrollment to the end of FU at 3 months

Study Arms (2)

Full access to a mobile App

EXPERIMENTAL

Study patients will receive full access to a mobile App

Device: Application of App

Restricted access to a mobile App

OTHER

Study patients will receive restricted access to a mobile App

Device: Application of App

Interventions

Application of AppDEVICE

Full Access to Mobile App

Full access to a mobile AppRestricted access to a mobile App

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \- Language barrier

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Bad Oeynhausen, 32545, Germany

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Central Study Contacts

Astrid Kleemeyer

CONTACT

49 5731 971258akleemeyer@hdz-nrw.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2024

First Posted

November 26, 2024

Study Start

August 21, 2024

Primary Completion

August 1, 2025

Study Completion

December 1, 2025

Last Updated

November 26, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)