VR Education in Arterial Hypertension

Arterial Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05735808
• Other study ID #: PAgel
• Status: Recruiting
• Phase: N/A
• Start date: July 7, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: July 2023
• Source: Poliklinika Agel, Dopravni zdravotnictvi a.s.
• Contact: Bogna Jiravska Godula, MD
• Phone: +420602579193
• Email: Bogna.jiravska-godula[@]npo.agel.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• all consecutive patients with arterial hypertension

Exclusion Criteria:

• visual impairment

Related Conditions & MeSH terms

• Arterial Hypertension
• Hypertension

Intervention

Behavioral:
• Physician based education
Regular education provided by physician
• VR based education
VR based education

Locations

Country	Name	City	State
Czechia	Poliklinika Agel	Ostrava

Sponsors (1)

Lead Sponsor	Collaborator
Poliklinika Agel, Dopravni zdravotnictvi a.s.

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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