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Virtual Reality Assisted Patient Empowerment: Diagnose ATTR-Amyloidosis And Start Treatment (VRAP-DAAST)

Primary Purpose

Amyloidosis Cardiac, Virtual Reality

Status
Not yet recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Intervention
Sponsored by
Heinrich-Heine University, Duesseldorf
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Amyloidosis Cardiac focused on measuring ATTR; cardiac amyloidosis; Virtual Reality; Suspected transthyretin amyloid cardiomyopathy

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

intervention

Control Group

Arm 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

Usual Care

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Duration patient-physician talk
Duration of the patient-physician talk in minutes.
Drug-Adherence to tafamidis
Drug-Adherence to tafamidis (yes/no/unknown)
health literacy: Baseline
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
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
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
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)
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)
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

Full Information

First Posted
June 20, 2023
Last Updated
July 3, 2023
Sponsor
Heinrich-Heine University, Duesseldorf
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1. Study Identification

Unique Protocol Identification Number
NCT05938218
Brief Title
Virtual Reality Assisted Patient Empowerment: Diagnose ATTR-Amyloidosis And Start Treatment
Acronym
VRAP-DAAST
Official Title
Virtual Reality Assisted Patient Empowerment: Diagnose ATTR-Amyloidosis And Start Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
December 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Heinrich-Heine University, Duesseldorf

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyloidosis Cardiac, Virtual Reality
Keywords
ATTR; cardiac amyloidosis; Virtual Reality; Suspected transthyretin amyloid cardiomyopathy

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
intervention
Arm Type
Experimental
Arm 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
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Usual Care
Intervention Type
Device
Intervention Name(s)
Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time-to-Event
Description
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
Time Frame
up to 180 days
Secondary Outcome Measure Information:
Title
Duration patient-physician talk
Description
Duration of the patient-physician talk in minutes.
Time Frame
up to 30 minutes
Title
Drug-Adherence to tafamidis
Description
Drug-Adherence to tafamidis (yes/no/unknown)
Time Frame
after 6 months after enrollment
Title
health literacy: Baseline
Description
In order to test to assess the health literacy at baseline, a health literacy questionnaire will be asked
Time Frame
1 hour before patient-physician talk after enrollment
Title
Health literacy: after the first patient-physician-talk
Description
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
Time Frame
1 hour after patient-physician talk]
Title
Health literacy baseline: Long term
Description
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
Time Frame
up to 180 days after patient-physician talk
Title
Rate of patients who died or were re-hospitalized during the long term follow up
Description
patients are contacted and information is gathered about survival of the patients and possible rehospitalization events due to cardiac events
Time Frame
after 6 and 12 months after enrollment
Title
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Description
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
Time Frame
after 6 months after enrollment
Title
Simulator Sickness Questionnaire (SSQ)
Description
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
Time Frame
immediately after Virtual Reality (VR-) Education

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Raphael Bruno, MD
Phone
+492118118000
Email
raphael.bruno@med.uni-duesseldorf.de
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa Dannenberg, MD
Phone
+492118105315
Email
ctu@med.uni-duesseldorf.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Jung, Prof. Dr.
Organizational Affiliation
Division of Cardiology, Pulmonary Disease and Vascular Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
University-Hospital Düsseldorf Division of Cardiology, Pulmonary Disease and Vascular Medicine [Recruiting] Düsseldorf, Germany, 40225
City
Düsseldorf
State/Province
NRW
ZIP/Postal Code
40225
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raphael Romano Bruno, MD
Phone
+492118106258
Email
raphael.bruno@med.uni-duesseldorf.de

12. IPD Sharing Statement

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

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