Impact of Enhanced Information on Subjective Information... | NCT06706635

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

NCT06706635

Sponsor

Heart and Diabetes Center North-Rhine Westfalia

Status

Recruiting

Last Update Posted

Nov 26, 2024Actual

Enrollment

250Estimated

Phase

Not Applicable

Conditions

Aortic Stenosis Disease

Interventions

Application of App

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 21, 2024Actual

Primary Completion Date

Aug 2025Estimated

Completion Date

Dec 2025Estimated

First Submitted Date

Nov 22, 2024

First Submission Date that Met QC Criteria

Nov 22, 2024

First Posted Date

Nov 26, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 22, 2024

Last Update Posted Date

Nov 26, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

250Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Application of App	Device	Full Access to Mobile App	Full access to a mobile App Restricted access to a mobile App

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Astrid Kleemeyer	Contact	49 5731 971258		akleemeyer@hdz-nrw.de

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinic for General and Interventional Cardiology/Angiology, Herz- und Diabeteszentrum NRW	Recruiting	Bad Oeynhausen		32545	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001024	Aortic Valve Stenosis

Ancestor Terms

ID	Term
D000082862	Aortic Valve Disease
D006349	Heart Valve Diseases
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided