NCT07399379

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
303

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 23, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2025

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 29, 2025

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

January 13, 2026

Completed
28 days until next milestone

First Posted

Study publicly available on registry

February 10, 2026

Completed
Last Updated

February 10, 2026

Status Verified

February 1, 2026

Enrollment Period

1.8 years

First QC Date

January 13, 2026

Last Update Submit

February 2, 2026

Conditions

Keywords

Augmented realityAcute Coronary SyndromeHeart FailurePacemakerPREMAtrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • MACE at one and six months

    From enrollment at one and six months

Study Arms (2)

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.

Device: Augmented reality app

Control group

NO INTERVENTION

This group receives the usual medical discharge report.

Interventions

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: 1. Video recorded by a cardiology professional: a brief and easy-to-understand explanation of the patient's condition, lasting approximately 2-3 minutes, provided by a hospital cardiology professional. 2. Treatment recommendations: a drop-down section with a table of discharge recommendations for the patient's condition, including lifestyle and dietary advice. 3. Warning signs: situations that the patient should pay attention to and seek medical advice if they occur.

Intervention Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • No access to a mobile device.
  • Untreated visual or hearing impairments that prevent viewing or understanding the videos.
  • Inability to understand Spanish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario de Getafe

Getafe, Madrid, 28905, Spain

Location

Related Publications (5)

  • Davies F. Perceived usefulness, perceived ease of use, and user acceptance of information technology. MIS Quarterly. 1989; 13: 319-40.

    BACKGROUND
  • 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.

    BACKGROUND
  • Kang X, Azizian M, Wilson E, et al. Stereoscopic augmented reality for laparoscopic surgery. Surg Endosc. 2014; 28: 2227-35.

    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.

    BACKGROUND

MeSH Terms

Conditions

Myocardial InfarctionHeart FailureAtrial FibrillationAcute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisArrhythmias, Cardiac

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2026

First Posted

February 10, 2026

Study Start

February 23, 2024

Primary Completion

December 16, 2025

Study Completion

December 29, 2025

Last Updated

February 10, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

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.

Locations