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

Virtual Reality Clinical Trial

— VRAP-DAAST  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05938218
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: December 1, 2025

Study information

• Verified date: July 2023
• Source: Heinrich-Heine University, Duesseldorf
• Contact: Raphael Bruno, MD
• Phone: +492118118000
• Email: raphael.bruno[@]med.uni-duesseldorf.de
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Amyloidosis
• Amyloidosis Cardiac
• Virtual Reality

Intervention

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.

Locations

Country	Name	City	State
Germany	University-Hospital Düsseldorf Division of Cardiology, Pulmonary Disease and Vascular Medicine [Recruiting] Düsseldorf, Germany, 40225	Düsseldorf	NRW

Sponsors (1)

Lead Sponsor	Collaborator
Heinrich-Heine University, Duesseldorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Duration patient-physician talk	Duration of the patient-physician talk in minutes.	up to 30 minutes
Secondary	Drug-Adherence to tafamidis	Drug-Adherence to tafamidis (yes/no/unknown)	after 6 months after enrollment
Secondary	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
Secondary	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]
Secondary	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
Secondary	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
Secondary	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
Secondary	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