Amyloidosis CardiacVRAP-DAASTNCT05938218
Virtual Reality Assisted Patient Empowerment: Diagnose ATTR-Amyloidosis And Start Treatment
A study testing Intervention in people with Amyloidosis Cardiac and Virtual Reality, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial summary
ATTR amyloidosis is a serious condition with significant morbidity and mortality. In Germany, there are numerous unreported cases of untreated patients, and diagnosing and initiating treatment often requires multiple specialized tests. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Amyloidosis Cardiac, Virtual Reality
- What is being tested?
- Intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 1 Dec 2023to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients who present themselves for assessment of an unclear septal thickening with suspicion of cardiac amyloidosis.
Who cannot join
- < 18 years
- Active Medication with tafamidis
- Cardiovascular Disease
- highly impaired vision or hearing
- advanced dementia syndrome
- epilepsy
- insufficient language skills
Trial locations and contacts
1 site in 1 country.
Germany1 site
University-Hospital Düsseldorf Division of Cardiology, Pulmonary Disease and Vascular Medicine [Recruiting] Düsseldorf, Germany, 40225
Düsseldorf, North Rhine-Westphalia, 40225
Raphael Romano Bruno, MD, +492118106258, raphael.bruno@med.uni-duesseldorf.de
About this study
ATTR amyloidosis is a serious condition with significant morbidity and mortality. In Germany, there are numerous unreported cases of untreated patients, and diagnosing and initiating treatment often requires multiple specialized tests. To address this, a study is being conducted to determine if virtual reality (VR)-based patient education can improve diagnosis rates, treatment initiation, and medication adherence compared to standard education methods.
Read the detailed description
Tafamidis is effective in reducing mortality and hospitalization in patients with transthyretin amyloid cardiomyopathy (ATTR-CM), and adherence to the drug is generally high. However, the main challenge lies in timely diagnosis and initiation of therapy. Virtual reality (VR) offers an immersive educational tool that surpasses conventional methods like brochures and videos, with patients preferring VR glasses. By preparing patients through VR, they can engage in informed conversations with physicians, understand the diagnostic process better, and be motivated to initiate therapy promptly. VR empowers patients and saves valuable time for physicians, and it has been well-received even among older cardiovascular patients
- Conditions
- Amyloidosis Cardiac, Virtual Reality
- Being tested
- Intervention
- Keywords
- ATTR; cardiac amyloidosis; Virtual Reality; Suspected transthyretin amyloid cardiomyopathy
- Medical subject headings
- Amyloid Neuropathies, Familial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionDevice
Virtual Reality assisted information Patients in the intervention group receive a VR instructional application lasting approximately 25 minutes. This intervention takes place in the waiting room prior to the actual physician-patient conversation and complements the usual care provided through brochures.
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | In this intervention, VR glasses with an information module are utilized, lasting approximately 25 minutes. This intervention takes place in the waiting room prior to the actual physician-patient conversation and complements the usual care provided through brochures Receives: Device: Intervention |
| Control Group | No intervention | Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-to-Event
Count days after first use of VR until the final diagnosis or prescription of tafamidis is given. [time frame: xx days]
- Time-to-Event [days] Count days after first use of VR until the final diagnosis or prescription of tafamidis is given. [time frame: xx days]
Count days after first use of VR until the final diagnosis or prescription of tafamidis is given
Measured: up to 180 days
Secondary outcomes (8)
Duration patient-physician talk
Duration of the patient-physician talk in minutes.
Measured: up to 30 minutes
Drug-Adherence to tafamidis
Drug-Adherence to tafamidis (yes/no/unknown)
Measured: after 6 months after enrollment
health literacy: Baseline
In order to test to assess the health literacy at baseline, a health literacy questionnaire will be asked
Measured: 1 hour before patient-physician talk after enrollment
Health literacy: after the first patient-physician-talk
In order to test to what extent the addition of a combination of different learning modalities (acoustic, visual, written, haptic) implemented in virtual reality to the medico-legal informed consent is superior to the standard informed consent, a survey is conducted after the informed consent using a health literacy questionnaire
Measured: 1 hour after patient-physician talk]
Health literacy baseline: Long term
In order to test to what extent the addition of a combination of different learning modalities (acoustic, visual, written, haptic) implemented in virtual reality to the medico-legal informed consent is superior to the standard informed consent, a survey is conducted after the informed consent in terms of long term effects using a health literacy questionnaire
Measured: up to 180 days after patient-physician talk
Rate of patients who died or were re-hospitalized during the long term follow up
patients are contacted and information is gathered about survival of the patients and possible rehospitalization events due to cardiac events
Measured: after 6 and 12 months after enrollment
Kansas City Cardiomyopathy Questionnaire (KCCQ)
KCCQ will be used to assess the general the patient's perception of their health status. In the KCCQ-12, responses are given on a Likert scale that for each individual item is scored on a scale of 0-100 with higher scores indicating better health
Measured: after 6 months after enrollment
Simulator Sickness Questionnaire (SSQ)
A SSQ will assess for VR associated compatibility. SSQ asks participants to provide subjective severity ratings of 16 symptoms on a scale from 0 (no perception) to 3 (severe perception) after the exposure. Total scores can be associated with negligible (< 5), minimal (5 - 10), significant (10 - 15), and concerning (15 - 20) symptoms
Measured: immediately after Virtual Reality (VR-) Education
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start1 Dec 2023 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyloidosis CardiacStudies of the same condition, open and under way.
- More trials run by Heinrich-Heine University, DuesseldorfThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In this intervention, VR glasses with an information module are utilized, lasting approximately 25 minutes. This intervention takes place in the waiting room prior to the actual physician-patient conversation and complements the usual care provided through brochures
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian Jung, Prof. Dr., Study chair, Division of Cardiology, Pulmonary Disease and Vascular Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05938218
- Acronym
- VRAP-DAAST
- Status last verified
- Jul 2023
- First submitted
- 20 Jun 2023
- Last updated
- 10 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Assisted Patient Empowerment: Diagnose ATTR-Amyloidosis And Start Treatment
- ClinicalTrials.gov ID
- NCT05938218
- Acronym / sponsor ID
- VRAP-DAAST
- Conditions
- Amyloidosis Cardiac, Virtual Reality
- Keywords
- ATTR; cardiac amyloidosis; Virtual Reality; Suspected transthyretin amyloid cardiomyopathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 10 Jul 2023 (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.
ATTR amyloidosis is a serious condition with significant morbidity and mortality. In Germany, there are numerous unreported cases of untreated patients, and diagnosing and initiating treatment often requires multiple specialized tests. To address this, a study is being conducted to determine if virtual reality (VR)-based patient education can improve diagnosis rates, treatment initiation, and medication adherence compared to standard education methods.
Detailed description
Tafamidis is effective in reducing mortality and hospitalization in patients with transthyretin amyloid cardiomyopathy (ATTR-CM), and adherence to the drug is generally high. However, the main challenge lies in timely diagnosis and initiation of therapy. Virtual reality (VR) offers an immersive educational tool that surpasses conventional methods like brochures and videos, with patients preferring VR glasses. By preparing patients through VR, they can engage in informed conversations with physicians, understand the diagnostic process better, and be motivated to initiate therapy promptly. VR empowers patients and saves valuable time for physicians, and it has been well-received even among older cardiovascular patients
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In this intervention, VR glasses with an information module are utilized, lasting approximately 25 minutes. This intervention takes place in the waiting room prior to the actual physician-patient conversation and complements the usual care provided through brochures
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Device: InterventionIn this intervention, VR glasses with an information module are utilized, lasting approximately 25 minutes. This intervention takes place in the waiting room prior to the actual physician-patient conversation and complements the usual care provided through brochures |
| Control Group | No intervention | –Usual Care |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients who present themselves for assessment of an unclear septal thickening with suspicion of cardiac amyloidosis.
Key exclusion criteria (7 listed)
- < 18 years
- Active Medication with tafamidis
- Cardiovascular Disease
- highly impaired vision or hearing
- advanced dementia syndrome
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 |
|---|---|---|
| InterventionVirtual Reality assisted information Patients in the intervention group receive a VR instructional application lasting approximately 25 minutes. This intervention takes place in the waiting room prior to the actual physician-patient conversation and complements the usual care provided through brochures. | Device | intervention |
Primary outcome
Time-to-Event
Time frame: up to 180 days
Count days after first use of VR until the final diagnosis or prescription of tafamidis is given. [time frame: xx days] 1. Time-to-Event [days] Count days after first use of VR until the final diagnosis or prescription of tafamidis is given. [time frame: xx days] Count days after first use of VR until the final diagnosis or prescription of tafamidis is given
8 secondary outcomes
Duration patient-physician talk
Time frame: up to 30 minutes
Drug-Adherence to tafamidis
Time frame: after 6 months after enrollment
health literacy: Baseline
Time frame: 1 hour before patient-physician talk after enrollment
Health literacy: after the first patient-physician-talk
Time frame: 1 hour after patient-physician talk]
Health literacy baseline: Long term
Time frame: up to 180 days after patient-physician talk
Rate of patients who died or were re-hospitalized during the long term follow up
Time frame: after 6 and 12 months after enrollment
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time frame: after 6 months after enrollment
Simulator Sickness Questionnaire (SSQ)
Time frame: immediately after Virtual Reality (VR-) Education
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2023.
Related trials for Amyloidosis Cardiac
Active, not recruitingObservational study
A Retrospective Observational Study of Epidemiology and Outcomes in Transthyretin Amyloid Cardiomyopathy in Germany
ATTR-CM (Transthyretin Amyloid Cardiomyopathy)
Active, not recruitingPhase 3
EPIC-ATTR: A Study to Evaluate the Effect of Eplontersen on the Transthyretin Reduction and Long-term Safety in Chinese Subjects With Transthyretin Amyloid Cardiomyopathy
Transthyretin Amyloid Cardiomyopathy
RecruitingObservational study
Essen Amyloidosis Registry
Amyloidosis; Systemic, Amyloidosis Cardiac
Active, not recruitingPhase 3
A Phase 3 Study of NTLA-2001 in ATTRv-PN
Neuromuscular Disease, Neuromuscular Diseases (NMD)
RecruitingPhase 3
MAGNITUDE: A Phase 3 Study of NTLA-2001 in Participants With Transthyretin Amyloidosis With Cardiomyopathy (ATTR-CM)
Transthyretin Amyloidosis (ATTR) With Cardiomyopathy
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. This study is not recruiting at the moment.
Christian Jung, Prof. Dr. study chair
Division of Cardiology, Pulmonary Disease and Vascular Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Amyloidosis Cardiac and Virtual Reality, run by Heinrich-Heine University, Duesseldorf 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 1 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 10 Jul 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raphael Bruno, MD (+492118118000, raphael.bruno@med.uni-duesseldorf.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time-to-Event (time frame: up to 180 days). 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 10 Jul 2023.