VR-3D Movie-based Education

OCULUS: a 3-D Movie to Improve Patient Compliance

Atrial fibrillation (AF), which is the most common cardiac arrhythmia in adults, is associated with a high risk of stroke and other thromboembolic complications. The usage of oral anticoagulation (OAC) may prevent the incidence of the thromboembolic events in the majority of patients. The current guidelines for the management of AF patients highlight the important role of patients' education, since the clinical benefit from OAC treatment may be achieved by the effective cooperation between patients and physicians. It has been suggested, that compliance may be increased by the novel e-solutions introduced into the daily clinical practice. Due to the improvement in advanced technologies, the virtual reality (VR) three-dimensional (3D) movie stands for a future alternative in e-medicine. The aim of the OCULUS study was to examine whether the 3D movie-based knowledge transfer is effective in teaching patients about the consequences of AF and pharmacological possibilities in reducing the risk of stroke.

Study Overview

• Status: Completed
• Conditions: mHealth
• Intervention / Treatment: Other: three-dimensional (3D) movie

Detailed Description

The OCULUS is a prospective, single centre study. The study will include hospitalized patients, who are over 18 years old. The only exclusion criteria of the study is the previously diagnosed dementia. The study is based on the questionnaire designed by the authors of the study, enclosing questions about sex, age, education, current job, AF history and knowledge about consequences of AF and the possibility of stroke prevention due to the OAC therapy. Subsequently, the brief VR-3D will be shown using the oculus glasses and a smartphone. The movie's plot informs about the risk of stroke and importance of the OAC therapy to prevent the incidence of the thromboembolic complications of AF. Consequently, patients will be asked several questions, including what was the movie about, whether AF can affect patient's life in a negative way, is it possible to reduce the risk of stroke and by what kind of drugs. Similar questions will be asked to the patients immediately after the movie, one week and one year later, via the Telephone follow-up.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Warsaw, Poland, 02-097
    • Paweł Balsam

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• >18 years old
• signed written informed consent

Exclusion Criteria:

• previously diagnosed dementia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: study group; All the patients will be shown three-dimensional (3D) movie.	Other: three-dimensional (3D) movie; Brief VR-3D will be shown using the oculus glasses and a smartphone. Then, patients will be asked several questions from the prepared questionnaire.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the effectiveness of the 3D-movie based knowledge transfer in teaching patients about the consequences of AF	The outcome will be assessed by questionnaire designed by the authors of the study, enclosing questions about sex, age, education, current job, AF history and knowledge about consequences of AF and the possibility of stroke prevention due to the OAC therapy.	1 year

Collaborators and Investigators

• Sponsor: Medical University of Warsaw
• Investigators: Principal Investigator: Paweł Balsam, MD, PhD, 1st Chair and Department of Cardiology, Medical University of Warsaw, Warsaw, Poland

Publications and helpful links

General Publications

• Balsam P, Borodzicz S, Malesa K, Puchta D, Tyminska A, Ozieranski K, Koltowski L, Peller M, Grabowski M, Filipiak KJ, Opolski G. OCULUS study: Virtual reality-based education in daily clinical practice. Cardiol J. 2019;26(3):260-264. doi: 10.5603/CJ.a2017.0154. Epub 2018 Jan 3.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): April 30, 2017
• Study Completion (Actual): May 30, 2017

Study Registration Dates

• First Submitted: March 28, 2017
• First Submitted That Met QC Criteria: March 31, 2017
• First Posted (Actual): April 7, 2017

Study Record Updates

• Last Update Posted (Actual): June 8, 2017
• Last Update Submitted That Met QC Criteria: June 7, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: atrial fibrillation; education; stroke prevention; e-medicine; oral anticoagulantion
• Other Study ID Numbers: OCULUS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will be able to share all of the data. They will be available on april 2017th.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No