VRAP-Heart - Virtual Reality Assisted Patient Empowerment for Interventions in Structural Heart Disease

Severe Aortic Valve Stenosis Clinical Trial

— VRAP-Heart  

Official title:

VRAP-Heart - Virtual Reality Assisted Patient Empowerment for Interventions in Structural Heart Disease - A Randomized-Controlled Multicenter Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05552352
• Other study ID #: VRAP-Heart
• Status: Recruiting
• Phase: N/A
• Start date: October 5, 2022
• Est. completion date: May 31, 2024

Study information

• Verified date: December 2022
• Source: Heinrich-Heine University, Duesseldorf
• Contact: Christian Jung, Prof MD PhD
• Phone: +49 211 81
• Email: christian.jung[@]med.uni-duesseldorf.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This prospective, randomized-controlled multicenter study investigates whether virtual reality-assisted patient education in patients undergoing transfemoral transcatheter aortic valve implantation (TAVI) can improve patient understanding and simulative orientation, thereby reducing postinterventional complications, resulting in significantly shorter length of stay.

Description:

This prospective, randomized-controlled multicenter study investigates whether VR-assisted patient education in patients undergoing transfemoral transcatheter aortic valve implantation (TAVI) can improve patient understanding and simulative orientation, thereby reducing postinterventional complications, resulting in significantly shorter length of stay. Disorientation, anxiety, and pain can lead to the development of delirium and, through complications, to prolonged hospital stays during elective procedures. Virtual reality can combine different learning modalities (auditory, visual, written, haptic) and improve patient understanding of the procedure through educational interventions. More detailed knowledge of the environment, the players, the procedure, and safety aspects will reduce anxiety and stress before and during the procedure and reduce complications during post-interventional care. As a result, length of stay should be reduced.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: May 31, 2024
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• High-grade aortic valve stenosis
• Indication for elective transfemoral transcatheter aortic valve implantation under analgesia (TAVI)
• Existing heart center decision
• Age = 18 years
• Signed informed consent form

Exclusion Criteria:

• Surgery planned under general anesthesia
• Language barrier
• Severe hearing or vision impairment
• Advanced dementia syndrome
• Known seizure disorder (epilepsy)
• Positive pregnancy test on inclusion and/or pregnancy is present
• Court ordered placement in an institution
• Any psychosocial condition that makes compliance with the protocol unlikely

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Heart Diseases
• Severe Aortic Valve Stenosis

Intervention

Other:
• Virtual Reality assisted information
Patients in the intervention group receive a VR instructional application in the patient's room the day before TAVI implantation and in the operational suite during TAVI implantation the next day. In this application, the patient is guided through different VR parts that repeat the indication, the procedure, the localities and the post-interventional phase of the implantation with the corresponding safety instructions.

Locations

Country	Name	City	State
Germany	Universitätsklinikum Düsseldorf, Klinik für Kardiologie, Pneumologie & Angiologie	Düsseldorf	NRW

Sponsors (2)

Lead Sponsor	Collaborator
Heinrich-Heine University, Duesseldorf	Edwards Lifesciences

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of hospital stay in days	Primary endpoint is the mean hospital stay in each group in days.	from start of hospitalizations until hospital leave up until day 360
Secondary	Mental state on the day before the procedure as assessed by visual analog scale	Anxiety and psychological stress are common before elective procedures such as TAVI. Both are considered triggers and amplifiers of delirium. Patients are asked to quantify their anxiety before the procedure using a visual analog scale ranging from 1 to 10.	1 day before procedure
Secondary	Mental state on the day before the procedure as assessed by State-Trait-Anxiety-Inventory questionnaire	Anxiety and psychological stress are common before elective procedures such as TAVI. Both are considered triggers and amplifiers of delirium. Patients are asked to quantify their anxiety before the procedure using State-Trait-Anxiety-Inventory with minimum outcome 10 and maximum outcome 80. Lesser outcome means more anxiety.	1 day before procedure
Secondary	Mental state on the day before the procedure as assessed by Hospital Anxiety and Depression Scale German Version questionnaire	Anxiety and psychological stress are common before elective procedures such as TAVI. Both are considered triggers and amplifiers of delirium. Patients are asked to quantify their anxiety before the procedure using Hospital Anxiety and Depression Scale German Version questionnaire. Anxiety scale in the questionnaire has values from 0 to 21 and Depression scale has values from 0 to 21. Lesser values denote less anxiety or depression.	1 day before procedure
Secondary	Anxiety during the procedure as assessed by visual analog scale	Anxiety and psychological stress are common during elective procedures such as TAVI. Both are considered triggers and amplifiers of delirium. Patients are asked to quantify their anxiety before the procedure using a visual analog scale ranging from 1 to 10.	during procedure
Secondary	Anxiety during the procedure as assessed by State-Trait-Anxiety-Inventory questionnaire	Anxiety and psychological stress are common during elective procedures such as TAVI. Both are considered triggers and amplifiers of delirium. Patients are asked to quantify their anxiety before the procedure using State-Trait-Anxiety-Inventory with minimum outcome 10 and maximum outcome 80. Lesser outcome means more anxiety.	during procedure
Secondary	Pain during the procedure	Pain can occur despite analgesia during an elective procedure such as TAVI. Pain is considered a trigger and amplifier of delirium. Patients are asked to quantify their pain on a visual analog scale during the procedure (time point: procedure performed but still in the hybrid operating room). Here, 0 corresponds to no pain and 10 to the maximum imaginable pain.	during procedure
Secondary	Anxiety/stress before, during, and after surgery (measured as serum cortisol)	Anxiety and psychological stress are common before and during elective procedures such as TAVI. Both are considered triggers and amplifiers of delirium. Patients will have routine blood samples taken before, during, and after the procedure. From these, the parameter cortisol in serum is additionally determined optionally in the context of this study. Serum cortisol is an established parameter to quantify anxiety and stress, especially intraindividually.	on the 1 day before, during and on day 1-3 after procedure
Secondary	Anxiety / stress before, during and after the procedure (amylase and cortisol in saliva).	Patients will have saliva samples taken before, during and after the procedure. From these, the parameters cortisol and alpha-amylase are additionally determined on an optional basis within the scope of this study. Both parameters are considered established to quantify anxiety and stress especially intraindividually.	on the 1 day before, during and on day 1-3 after procedure
Secondary	Knowledge test after informed consent	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.	1 day before procedure after informed consent
Secondary	Major bleeding and minor bleeding during hospitalization.	Bleeding is a typical complication after cardio-vascular interventional procedures. Unawareness, disorientation, falls, and delirium favor the occurrence of bleeding. After hospital discharge, the occurrence of bleeding is recorded according to Valve Academic Research Consortium-2 consensus document (VARC), which is based on the bleeding academic research consortium (BARC) classification.	at hospital leave up to 360 days after procedure
Secondary	Survival / rehospitalization at 6 and 12 months	After 6 and 12 months patients are contacted and information is gathered about survival of the patients and possible rehospitalization events.	after 6 and 12 months after hospital leave
Secondary	Maximum length of hospital stay, in days	In addition to the mean hospital stay in days, a maximum hospital stay is also calculated.	at hospital leave up to 360 days after procedure