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VR-3D Movie-based Education

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03104231
Recruitment Status : Completed
First Posted : April 7, 2017
Last Update Posted : June 8, 2017
Sponsor:
Information provided by (Responsible Party):
Marcin Grabowski, Medical University of Warsaw

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
mHealth Other: three-dimensional (3D) movie Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: OCULUS: a 3-D Movie to Improve Patient Compliance
Actual Study Start Date : April 1, 2016
Actual Primary Completion Date : April 30, 2017
Actual Study Completion Date : May 30, 2017
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Assessment of the effectiveness of the 3D-movie based knowledge transfer in teaching patients about the consequences of AF [ Time Frame: 1 year ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • >18 years old
  • signed written informed consent

Exclusion Criteria:

  • previously diagnosed dementia
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03104231


Locations
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Poland
Paweł Balsam
Warsaw, Poland, 02-097
Sponsors and Collaborators
Medical University of Warsaw
Investigators
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Principal Investigator: Paweł Balsam, MD, PhD 1st Chair and Department of Cardiology, Medical University of Warsaw, Warsaw, Poland
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Marcin Grabowski, Ass. Prof, Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT03104231    
Other Study ID Numbers: OCULUS
First Posted: April 7, 2017    Key Record Dates
Last Update Posted: June 8, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We will be able to share all of the data. They will be available on april 2017th.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marcin Grabowski, Medical University of Warsaw:
atrial fibrillation
oral anticoagulantion
stroke prevention
education
e-medicine