VR Education in Arterial Hypertension

A Pilot Study of the Feasibility and Non-inferiority of Patient Education About Arterial Hypertension in Virtual Reality

The aim of this study is to compare standard education with VR augmented education in patients with arterial hypertension

Study Overview

• Status: Recruiting
• Conditions: Arterial Hypertension
• Intervention / Treatment: Behavioral: Physician based education; Behavioral: VR based education

Detailed Description

To demonstrate the technical and organizational feasibility of patient education about arterial hypertension in virtual reality. Demonstrate the non-inferiority of education conducted in virtual reality to traditional face-to-face education by a physician. To define the cost-effectiveness of education in virtual reality in the reality of progressing shortage of human resources.

Patients diagnosed with arterial hypertension as part of a routine examination in an internal medicine outpatient clinic will be randomized to education about the disease directly by a physician in one arm or using a 3D movie in VR glasses filmed by a physician in an identical outpatient clinic setting. It will be concluded by questionnaire method to compare the outcome of both education namely subjective satisfaction and objectively by using questions to evaluate the success of the education.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bogna Jiravska Godula, MD; Phone Number: +420602579193; Email: Bogna.jiravska-godula@npo.agel.cz

Study Locations

• Czechia
  • Ostrava, Czechia
    • Recruiting
    • Poliklinika Agel
    • Contact: Bogna Jiravska Godula, MD; Phone Number: +420724307894; Email: bogna.jiravska-godula@npo.agel.cz
    • Contact: Otakar Jiravsky, MD; Phone Number: +420602579193; Email: otakar.jiravsky@npo.agel.cz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• all consecutive patients with arterial hypertension

Exclusion Criteria:

• visual impairment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standart physicain based education; In this arm, patient education will be conducted by the physician as the gold standard.	Behavioral: Physician based education; Regular education provided by physician
Experimental: VR based education; In this arm, patient education will be performed using 3D educational material presented in VR glasses.	Behavioral: VR based education; VR based education

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Non-Inferiority of VR augmented education: physician assessment of objective patient understanding	After the education, the patient will answer a prepared list of questions on arterial hypertension whose answers were mentioned in the previous education and the percentage of correct/wrong answers will be compared in both arms of the study.	18 months
Non-Inferiority of VR augmented education:subjective evaluation of education by the patient	After the education, the patient will rate how he/she subjectively perceived the subjective pleasantness of the education on a scale of 1 to 5 ( 1 best/ 5 worst).	18 months

Collaborators and Investigators

• Sponsor: Poliklinika Agel, Dopravni zdravotnictvi a.s.
• Investigators: Study Chair: Otakar Jiravsky, Nemocnice AGEL Trinec-Podlesi a.s.

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2023
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: January 12, 2023
• First Submitted That Met QC Criteria: February 17, 2023
• First Posted (Actual): February 21, 2023

Study Record Updates

• Last Update Posted (Actual): July 10, 2023
• Last Update Submitted That Met QC Criteria: July 7, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: virtual reality education
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: PAgel

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Only basic demographic data will be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No