NCT05735808

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 21, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

July 7, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

July 10, 2023

Status Verified

July 1, 2023

Enrollment Period

6 months

First QC Date

January 12, 2023

Last Update Submit

July 7, 2023

Conditions

Arterial Hypertension

Keywords

virtual reality education

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Standart physicain based education

ACTIVE COMPARATOR

In this arm, patient education will be conducted by the physician as the gold standard.

Behavioral: Physician based education

VR based education

EXPERIMENTAL

In this arm, patient education will be performed using 3D educational material presented in VR glasses.

Behavioral: VR based education

Interventions

Physician based educationBEHAVIORAL

Regular education provided by physician

Standart physicain based education
VR based educationBEHAVIORAL

VR based education

VR based education

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • all consecutive patients with arterial hypertension

You may not qualify if:

  • visual impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Poliklinika Agel

Ostrava, Czechia

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Otakar Jiravsky

    Nemocnice AGEL Trinec-Podlesi a.s.

    STUDY CHAIR

Central Study Contacts

Bogna Jiravska Godula, MD

CONTACT

+420602579193Bogna.jiravska-godula@npo.agel.cz

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

January 12, 2023

First Posted

February 21, 2023

Study Start

July 7, 2023

Primary Completion

December 31, 2023

Study Completion

June 30, 2024

Last Updated

July 10, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Only basic demographic data will be shared

Locations

CZ(1)