- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07399379
Augmented Reality as Discharge Information for Hospitalized Cardiology Patients (RACAR)
Implementation of an Augmented Reality System to Complement Discharge Information in Hospitalized Cardiology Patients
The goal of this clinical trial is to find out whether a simple augmented reality tool provided at hospital discharge can improve patients' understanding of their care, adherence to treatment, and health outcomes, compared with the usual discharge information.
This study includes adult patients who are admitted to a cardiology department because of:
- Ischaemic heart disease
- Atrial fibrillation
- Heart failure
- Or who need a pacemaker implantation
The main questions this study aims to answer are:
- Does providing augmented reality information at discharge improve patients' perceived quality of care?
- Does it improve patients' adherence to their prescribed treatment?
- Does it reduce major cardiovascular events such as hospital readmission, heart attack, stroke, or cardiovascular death?
Researchers will compare two groups of participants:
- A control group, who will receive the usual medical discharge report.
- An intervention group, who will receive the usual medical discharge report plus an information card with a drawing and a QR code that gives access to an augmented reality application.
Participants will:
- Receive their discharge information according to the group they are assigned to.
- Use the augmented reality application if they are in the intervention group.
- Be followed over time to assess treatment adherence, patient experience, and cardiovascular events.
This is a low-intervention, randomized, single-centre clinical trial conducted in Getafe, Madrid, Spain. Participation in this study does not involve taking any additional medication.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Madrid
-
Getafe, Madrid, Spain, 28905
- Hospital Universitario de Getafe
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Participants must have access to a mobile device (such as a smartphone or tablet).
- Participants must have been admitted to the Cardiology Department of Getafe University Hospital for ischemic heart disease, heart failure, atrial fibrillation, or pacemaker implantation.
Exclusion Criteria:
- No access to a mobile device.
- Untreated visual or hearing impairments that prevent viewing or understanding the videos.
- Inability to understand Spanish
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Intervention Group
This group receives the usual medical discharge report plus an information card with a drawing and a QR code that gives access to an augmented reality application explaining their disease.
|
The card provided in addition to the usual medical discharge report is designed with a simple drawing that identifies each condition and a QR code. This code can be scanned from any mobile device using the device's camera. Once scanned, a 3D model of a heart or a stent (depending on the condition) appears on the device, showing movement, vibration, and sound as an example of augmented reality. The user can also access simple options through three buttons:
|
|
No Intervention: Control group
This group receives the usual medical discharge report.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PRIMARY OUTCOME: PREM and treatment adherence at one and six months
Time Frame: Follow up at one and six months from enrollment
|
To assess PREM (Patient-Reported Experience Measures) in the intervention group and in the control group at discharge and at follow-up.
|
Follow up at one and six months from enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
MACE at one and six months
Time Frame: From enrollment at one and six months
|
Data on major adverse cardiovascular events (MACE) will also be collected at one and six months from discharge in both groups.
MACE include heart attack, stroke, cardiovascular-related hospital readmission, and cardiovascular death.
|
From enrollment at one and six months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Davies F. Perceived usefulness, perceived ease of use, and user acceptance of information technology. MIS Quarterly. 1989; 13: 319-40.
- Labanas V, Loukas C, Smailis N, et al. A novel augmented reality simulator for skills assessment in minimal invasive surgery. Surg Endosc. 2015; 29: 2224-34.
- Kang X, Azizian M, Wilson E, et al. Stereoscopic augmented reality for laparoscopic surgery. Surg Endosc. 2014; 28: 2227-35.
- Barroso Osuna, J., & Cabero Almenara, J. (2016). Evaluación de objetos de aprendizaje en Realidad Aumentada: estudio piloto en el grado de Medicina. Enseñanza & Teaching: Revista Interuniversitaria De Didáctica, 34(2), 149-67. https://doi.org/10.14201/et2016342149167.
- Almenara, J.C., Osuna, J.B., Puente, Á.P., et al. Realidad Aumentada para aumentar la formación en la enseñanza de la Medicina. Educ. Medica. Super. 2018; 32 (4): 1-14.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEIm 23/44
- SEC/FEC-INV-CLI 23/12 (Other Grant/Funding Number: Spanish Society of Cardiology)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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