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| ID | Type | Description | Link |
|---|---|---|---|
| SEC/FEC-INV-CLI 23/12 | Other Grant/Funding Number | Spanish Society of Cardiology |
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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:
The main questions this study aims to answer are:
Researchers will compare two groups of participants:
Participants will:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Active Comparator | 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. |
|
| Control group | No Intervention | This group receives the usual medical discharge report. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Augmented reality app | Device | 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| PRIMARY OUTCOME: PREM and treatment adherence at one and six months | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| MACE 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario de Getafe | Getafe | Madrid | 28905 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Davies F. Perceived usefulness, perceived ease of use, and user acceptance of information technology. MIS Quarterly. 1989; 13: 319-40. | ||
| 25303925 | Background | Lahanas V, Loukas C, Smailis N, Georgiou E. A novel augmented reality simulator for skills assessment in minimal invasive surgery. Surg Endosc. 2015 Aug;29(8):2224-34. doi: 10.1007/s00464-014-3930-y. Epub 2014 Oct 11. | |
| 24488352 |
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Individual Participant Data will not be shared because the dataset contains sensitive patient health information, including medical history and follow-up outcomes. Sharing these data could risk patient confidentiality. All data will be handled according to current data protection regulations and only anonymized, aggregated results will be made publicly available.
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D006333 | Heart Failure |
| D001281 | Atrial Fibrillation |
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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|
| Background |
| Kang X, Azizian M, Wilson E, Wu K, Martin AD, Kane TD, Peters CA, Cleary K, Shekhar R. Stereoscopic augmented reality for laparoscopic surgery. Surg Endosc. 2014 Jul;28(7):2227-35. doi: 10.1007/s00464-014-3433-x. Epub 2014 Feb 1. |
| Background | 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. |
| Background | 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. |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D001145 | Arrhythmias, Cardiac |