Back to resultsVR Education in Arterial Hypertension
Primary Purpose
Arterial Hypertension
Status
Recruiting
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Physician based education
VR based education
Sponsored by
About this trial
This is an interventional other trial for Arterial Hypertension focused on measuring virtual reality education
Eligibility Criteria
Inclusion Criteria: all consecutive patients with arterial hypertension Exclusion Criteria: visual impairment
Sites / Locations
- Poliklinika AgelRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standart physicain based education
VR based education
Arm Description
In this arm, patient education will be conducted by the physician as the gold standard.
In this arm, patient education will be performed using 3D educational material presented in VR glasses.
Outcomes
Primary Outcome Measures
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.
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT05735808
First Posted
January 12, 2023
Last Updated
July 7, 2023
Sponsor
Poliklinika Agel, Dopravni zdravotnictvi a.s.
1. Study Identification
Unique Protocol Identification Number
NCT05735808
Brief Title
VR Education in Arterial Hypertension
Official Title
A Pilot Study of the Feasibility and Non-inferiority of Patient Education About Arterial Hypertension in Virtual Reality
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 7, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Poliklinika Agel, Dopravni zdravotnictvi a.s.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to compare standard education with VR augmented education in patients with arterial hypertension
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arterial Hypertension
Keywords
virtual reality education
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standart physicain based education
Arm Type
Active Comparator
Arm Description
In this arm, patient education will be conducted by the physician as the gold standard.
Arm Title
VR based education
Arm Type
Experimental
Arm Description
In this arm, patient education will be performed using 3D educational material presented in VR glasses.
Intervention Type
Behavioral
Intervention Name(s)
Physician based education
Intervention Description
Regular education provided by physician
Intervention Type
Behavioral
Intervention Name(s)
VR based education
Intervention Description
VR based education
Primary Outcome Measure Information:
Title
Non-Inferiority of VR augmented education: physician assessment of objective patient understanding
Description
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.
Time Frame
18 months
Title
Non-Inferiority of VR augmented education:subjective evaluation of education by the patient
Description
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).
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
all consecutive patients with arterial hypertension
Exclusion Criteria:
visual impairment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bogna Jiravska Godula, MD
Phone
+420602579193
Email
Bogna.jiravska-godula@npo.agel.cz
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Otakar Jiravsky
Organizational Affiliation
Nemocnice AGEL Trinec-Podlesi a.s.
Official's Role
Study Chair
Facility Information:
Facility Name
Poliklinika Agel
City
Ostrava
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bogna Jiravska Godula, MD
Phone
+420724307894
Email
bogna.jiravska-godula@npo.agel.cz
First Name & Middle Initial & Last Name & Degree
Otakar Jiravský, MD
Phone
+420602579193
Email
otakar.jiravsky@npo.agel.cz
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Only basic demographic data will be shared
Learn more about this trial
VR Education in Arterial Hypertension
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