VR Education in Arterial Hypertension

Sponsor

Poliklinika Agel, Dopravni zdravotnictvi a.s. (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05735808

Collaborator

(none)

100

Enrollment

Location

Arms

16.3

Anticipated Duration (Months)

6.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Arterial Hypertension	Behavioral: Physician based education Behavioral: VR based education	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Feb 20, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Jun 30, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Non-Inferiority of VR augmented education: physician assessment of objective patient understanding [18 months]
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.
Non-Inferiority of VR augmented education:subjective evaluation of education by the patient [18 months]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

all consecutive patients with arterial hypertension

Exclusion Criteria:

visual impairment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Poliklinika Agel	Ostrava		Czechia

Sponsors and Collaborators

Poliklinika Agel, Dopravni zdravotnictvi a.s.

Investigators

Study Chair: Otakar Jiravsky, Nemocnice AGEL Trinec-Podlesi a.s.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Bogna Jiravska Godula, PI, Poliklinika Agel, Dopravni zdravotnictvi a.s.

ClinicalTrials.gov Identifier:

NCT05735808

Other Study ID Numbers:

PAgel

First Posted:

Feb 21, 2023

Last Update Posted:

Feb 21, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Bogna Jiravska Godula, PI, Poliklinika Agel, Dopravni zdravotnictvi a.s.

virtual reality education

Additional relevant MeSH terms:

Hypertension

Study Results

No Results Posted as of Feb 21, 2023