Aortic Stenosis DiseaseTAVI-SDM-APPNCT06706635
Impact of Enhanced Information on Subjective Information Level and PROMs in Patients with Aortic Stenosis
A study testing Application of App in people with Aortic Stenosis Disease, run by Heart and Diabetes Center North-Rhine Westfalia at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Stenosis Disease
- What is being tested?
- Application of App
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteGermany
- Study dates
- 21 Aug 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Language barrier
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Clinic for General and Interventional Cardiology/Angiology, Herz- und Diabeteszentrum NRW
Bad Oeynhausen, 32545
Astrid Kleemeyer, +49 5731 971258, akleemeyer@hdz-nrw.de
Tanja K. Rudolph, MD
About this study
Official title: 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.
- Conditions
- Aortic Stenosis Disease
- Being tested
- Application of App
- Keywords
- aortic stenosis, mobile app
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of AppDevice
Full Access to Mobile App
| Study group | Role | What they receive |
|---|---|---|
| Full access to a mobile App | Experimental | Study patients will receive full access to a mobile App Receives: Device: Application of App |
| Restricted access to a mobile App | Other | Study patients will receive restricted access to a mobile App Receives: Device: Application of App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective information level (EORTC QOL-INFO 25 questionnaire)
Measured: From enrollment to the end of FU at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start21 Aug 2024
- Primary completionAug 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Stenosis DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heart and Diabetes Center North-Rhine Westfalia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06706635
- Sponsor's protocol ID
- HDZ-KA_023_TR
- Acronym
- TAVI-SDM-APP
- Status last verified
- Nov 2024
- First submitted
- 22 Nov 2024
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06706635
- Acronym / sponsor ID
- TAVI-SDM-APP / HDZ-KA_023_TR
- Conditions
- Aortic Stenosis Disease
- Keywords
- aortic stenosis, mobile app
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Heart and Diabetes Center North-Rhine WestfaliaUniversity, hospital or other
- Study start
- 21 Aug 2024 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 26 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Full access to a mobile App | Experimental | Device: Application of AppStudy patients will receive full access to a mobile App |
| Restricted access to a mobile App | Other | Device: Application of AppStudy patients will receive restricted access to a mobile App |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Language barrier
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Application of AppFull Access to Mobile App | Device | Full access to a mobile App, Restricted access to a mobile App |
Primary outcome
Subjective information level (EORTC QOL-INFO 25 questionnaire)
Time frame: From enrollment to the end of FU at 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Application of App in people with Aortic Stenosis Disease, run by Heart and Diabetes Center North-Rhine Westfalia at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Astrid Kleemeyer (49 5731 971258, akleemeyer@hdz-nrw.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective information level (EORTC QOL-INFO 25 questionnaire) (time frame: From enrollment to the end of FU at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2024.