Virtual Reality Assisted Patient Empowerment: Diagnose ATTR-Amyloidosis And Start Treatment

Study Overview
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Brief Summary
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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
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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

Official Title
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Virtual Reality Assisted Patient Empowerment: Diagnose ATTR-Amyloidosis And Start Treatment

Conditions
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Amyloidosis Cardiac, Virtual Reality

Intervention / Treatment
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* Device: Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients who present themselves for assessment of an unclear septal thickening with suspicion of cardiac amyloidosis. Exclusion Criteria: < 18 years Active Medication with tafamidis Cardiovascular Disease highly impaired vision or hearing advanced dementia syndrome epilepsy insufficient language skills

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention<br>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<br>* 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.<br>|
| No Intervention: Control Group<br>Usual Care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | up to 180 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration patient-physician talk | Duration of the patient-physician talk in minutes. | up to 30 minutes | 
| Drug-Adherence to tafamidis | Drug-Adherence to tafamidis (yes/no/unknown) | 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 | 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 | 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 | 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 | 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 | 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 | immediately after Virtual Reality (VR-) Education | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ATTR; cardiac amyloidosis; Virtual Reality; Suspected transthyretin amyloid cardiomyopathy