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

NCT05938218 | Unknown DMC

• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Amyloidosis Cardiac; Virtual Reality

Keywords

ATTR; cardiac amyloidosis; Virtual Reality; Suspected transthyretin amyloid cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Duration patient-physician talk

  up to 30 minutes

• Drug-Adherence to tafamidis

  after 6 months after enrollment

• health literacy: Baseline

  1 hour before patient-physician talk after enrollment

• Health literacy: after the first patient-physician-talk

  1 hour after patient-physician talk]

• Health literacy baseline: Long term

  up to 180 days after patient-physician talk

Study Arms (2)

intervention

EXPERIMENTAL

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

Control Group

NO INTERVENTION

Usual Care

Interventions

Intervention DEVICE

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.

intervention

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \< 18 years
• Active Medication with tafamidis
• Cardiovascular Disease
• highly impaired vision or hearing
• advanced dementia syndrome
• epilepsy
• insufficient language skills

Sponsors & Collaborators

• Heinrich-Heine University, Duesseldorf: lead

Study Sites (1)

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

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

MeSH Terms

Conditions

Amyloid Neuropathies, Familial

Interventions

Methods

Condition Hierarchy (Ancestors)

Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Nervous System Diseases; Amyloid Neuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amyloidosis, Familial; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases; Amyloidosis; Proteostasis Deficiencies

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Christian Jung, Prof. Dr.

  Division of Cardiology, Pulmonary Disease and Vascular Medicine

  STUDY CHAIR

Central Study Contacts

Raphael Bruno, MD

CONTACT

+492118118000; raphael.bruno@med.uni-duesseldorf.de

Lisa Dannenberg, MD

CONTACT

+492118105315; ctu@med.uni-duesseldorf.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: June 20, 2023
• First Posted: July 10, 2023
• Study Start: December 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: July 10, 2023

Record last verified: 2023-07

Locations

DE (1)