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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05735808
Other study ID # PAgel
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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