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

Not Applicable

Not yet recruiting

• Conditions: Amyloidosis Cardiac; Virtual Reality

• Registration Number: NCT05938218
• Lead Sponsor: Heinrich-Heine University, Duesseldorf

Brief 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.

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 Timeline

• Study First Submitted: 2023-06-20
• Status Verified: 2023-07
• Study First Submitted QC: 2023-07-03
• Last Update Submitted: 2023-07-03
• Study First Posted: 2023-07-10
• Last Update Posted: 2023-07-10
• Study Start: 2023-12-01
• Primary Completion: 2024-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time-to-Event	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

Secondary Outcome Measures

Name	Time	Method
Health literacy baseline: Long term	up to 180 days after 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 in terms of long term effects using a health literacy questionnaire
health literacy: Baseline	1 hour before patient-physician talk after enrollment	In order to test to assess the health literacy at baseline, a health literacy questionnaire will be asked
Rate of patients who died or were re-hospitalized during the long term follow up	after 6 and 12 months after enrollment	patients are contacted and information is gathered about survival of the patients and possible rehospitalization events due to cardiac events
Simulator Sickness Questionnaire (SSQ)	immediately after Virtual Reality (VR-) Education	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
Duration patient-physician talk	up to 30 minutes	Duration of the patient-physician talk in minutes.
Kansas City Cardiomyopathy Questionnaire (KCCQ)	after 6 months after enrollment	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
Drug-Adherence to tafamidis	after 6 months after enrollment	Drug-Adherence to tafamidis (yes/no/unknown)
Health literacy: after the first patient-physician-talk	1 hour after 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

Trial Locations

Locations (1)

University-Hospital Düsseldorf Division of Cardiology, Pulmonary Disease and Vascular Medicine [Recruiting] Düsseldorf, Germany, 40225; 🇩🇪 Düsseldorf, NRW, Germany