Virtual Reality Assisted Patient Empowerment: Diagnose ATTR-Amyloidosis And Start Treatment (VRAP-DAAST)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Virtual Reality; Amyloidosis Cardiac
• Intervention / Treatment: Device: Intervention

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Raphael Bruno, MD; Phone Number: +492118118000; Email: raphael.bruno@med.uni-duesseldorf.de
• Study Contact Backup: Name: Lisa Dannenberg, MD; Phone Number: +492118105315; Email: ctu@med.uni-duesseldorf.de

Study Locations

• Germany
  • NRW
    • Düsseldorf, NRW, Germany, 40225
      • University-Hospital Düsseldorf Division of Cardiology, Pulmonary Disease and Vascular Medicine [Recruiting] Düsseldorf, Germany, 40225
      • Contact: Raphael Romano Bruno, MD; Phone Number: +492118106258; Email: raphael.bruno@med.uni-duesseldorf.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• patients who present themselves for assessment of an unclear septal thickening with suspicion of cardiac amyloidosis.

Exclusion Criteria:

1. < 18 years
2. Active Medication with tafamidis
3. Cardiovascular Disease
4. highly impaired vision or hearing
5. advanced dementia syndrome
6. epilepsy
7. insufficient language skills

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; Usual Care
Experimental: intervention; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Heinrich-Heine University, Duesseldorf
• Investigators: Study Chair: Christian Jung, Prof. Dr., Division of Cardiology, Pulmonary Disease and Vascular Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: June 20, 2023
• First Submitted That Met QC Criteria: July 3, 2023
• First Posted (Actual): July 10, 2023

Study Record Updates

• Last Update Posted (Actual): July 10, 2023
• Last Update Submitted That Met QC Criteria: July 3, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: ATTR; cardiac amyloidosis; Virtual Reality; Suspected transthyretin amyloid cardiomyopathy
• Additional Relevant MeSH Terms: Metabolic Diseases; Proteostasis Deficiencies; Amyloidosis

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No