VR-3D Movie-based Education

mHealth Clinical Trial

Official title:

OCULUS: a 3-D Movie to Improve Patient Compliance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03104231
• Other study ID #: OCULUS
• Status: Completed
• Phase: N/A
• First received: March 28, 2017
• Last updated: June 7, 2017
• Start date: April 1, 2016
• Est. completion date: May 30, 2017

Study information

• Verified date: June 2017
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 30, 2017
• Est. primary completion date: April 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• >18 years old

• signed written informed consent

Exclusion Criteria:

• previously diagnosed dementia

Related Conditions & MeSH terms

• mHealth

Intervention

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.

Locations

Country	Name	City	State
Poland	Pawel Balsam	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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