An interventional study of Intervention in Amyloidosis Cardiac and Virtual Reality, sponsored by Heinrich-Heine University, Duesseldorf. Not yet recruiting at 1 site in Germany. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-10.
Sponsored by Heinrich-Heine University, Duesseldorf · Not applicable, Interventional, and Basic science
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.
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
491 studies on the registry are indexed under Amyloidosis; 135 are open to participants now.
This study's planned enrollment of 60 is above the median of 40 across 304 interventional studies indexed under Amyloidosis.
Browse Amyloidosis studies →Heinrich-Heine University, Duesseldorf is the lead sponsor of 174 studies on the registry; 52 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Device: Intervention
Usual Care
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.
Time-to-Event
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
Time frame: up to 180 days
Duration patient-physician talk
Duration of the patient-physician talk in minutes.
Time frame: up to 30 minutes
Drug-Adherence to tafamidis
Drug-Adherence to tafamidis (yes/no/unknown)
Time frame: 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
Time frame: 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
Time frame: 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
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
patients are contacted and information is gathered about survival of the patients and possible rehospitalization events due to cardiac events
Time frame: 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
Time frame: 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
Time frame: immediately after Virtual Reality (VR-) Education
This study is not yet recruiting, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Heinrich-Heine University, Duesseldorf