Clinical trial NCT05938218: Virtual Reality Assisted Patient Empowerment: Diagnose ATTR-Amyloidosis And Start Treatment
Official title: Virtual Reality Assisted Patient Empowerment: Diagnose ATTR-Amyloidosis And Start Treatment
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Amyloidosis Cardiac
Virtual Reality
Keywords: ATTR; cardiac amyloidosis; Virtual Reality; Suspected transthyretin amyloid cardiomyopathy
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2023-07-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: BASIC_SCIENCE

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

Eligibility criteria: 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

Primary outcomes:
measure: Time-to-Event
timeFrame: up to 180 days
Secondary outcomes:
measure: Duration patient-physician talk
timeFrame: up to 30 minutes
measure: Drug-Adherence to tafamidis
timeFrame: after 6 months after enrollment
measure: health literacy: Baseline
timeFrame: 1 hour before patient-physician talk after enrollment
measure: Health literacy: after the first patient-physician-talk
timeFrame: 1 hour after patient-physician talk]
measure: Health literacy baseline: Long term
timeFrame: up to 180 days after patient-physician talk
measure: Rate of patients who died or were re-hospitalized during the long term follow up
timeFrame: after 6 and 12 months after enrollment
measure: Kansas City Cardiomyopathy Questionnaire (KCCQ)
timeFrame: after 6 months after enrollment
measure: Simulator Sickness Questionnaire (SSQ)
timeFrame: immediately after Virtual Reality (VR-) Education
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: University-Hospital Düsseldorf Division of Cardiology, Pulmonary Disease and Vascular Medicine [Recruiting] Düsseldorf, Germany, 40225
state: NRW
Study officials:
affiliation: Division of Cardiology, Pulmonary Disease and Vascular Medicine
name: Christian Jung, Prof. Dr.
role: STUDY_CHAIR
References: