VRAP-DAAST: Virtual Reality Assisted Patient Empowerment: Diagnose ATTR-Amyloidosis And Start Treatment
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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.
|
| No Intervention: Control Group Usual Care |
Outcome Measures
Primary Outcome Measures
- 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
- Duration patient-physician talk [up to 30 minutes]
Duration of the patient-physician talk in minutes.
- Drug-Adherence to tafamidis [after 6 months after enrollment]
Drug-Adherence to tafamidis (yes/no/unknown)
- 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
- 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
- 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
- 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
- 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
- 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
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University-Hospital Düsseldorf Division of Cardiology, Pulmonary Disease and Vascular Medicine [Recruiting] Düsseldorf, Germany, 40225 | Düsseldorf | NRW | Germany | 40225 |
Sponsors and Collaborators
- Heinrich-Heine University, Duesseldorf
Investigators
- Study Chair: Christian Jung, Prof. Dr., Division of Cardiology, Pulmonary Disease and Vascular Medicine