Randomized, Single Center Study About the Impact of an E-learning Dedicated to Myocardial Infarction Patient

NCT ID: NCT03949608

Last Updated: 2020-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-04
• Study Completion Date: 2020-07-15

Brief Summary

Acute coronary syndrome (ACS) is still one of the major cause of morbi-mortality in Europe. After an ACS, patients should be treated with secondary prevention medication to reduce the risk of recurrence. However, it is known that patients do not take all their medicines as expected, which leads to readmission at the hospital. To enhance drug adherence, the investigators sought to develop an interactive e-learning tool for these patients. This e-learning includes information about the disease, the acute care and the subsequent medications being prescribed. The tool is now ready to use and the investigators want to assess if it has the impact to enhance self-care management of ACS patients.

Detailed Description

Cardiovascular disease is a major cause of morbi-mortality in industrialized countries. Risk of recurrence after appropriate treatment is particularly frequent in patients with inadequate observance. Secondary prevention is therefore essential to reduce the morbi-mortality of high-risk cardiovascular patients. Risk factor control and lifestyle interventions are important for these high-risk patients to reduce the overall incidence of cardiac disease. To treat these risk factors and for secondary prevention after a cardiovascular event, some medications have been shown to be efficient and European guidelines have been written to enhance evidence-based medicine prescriptions for STEMI and NSTEMI. Despite this, concerns have been postulated about patient's self-adherence to these treatments. A study has shown a long-term adherence to medications of 71% for Aspirin, 46% for β-blockers and 44% for Lipid-lowering therapy for Coronary Artery Disease (CAD) patients. Non-adherence has been associated with increased morbi-mortality in this population.

Therefore, a variety of interventions was identified to enhance patient adherence to medication in the cardiovascular field. These strategies included:

• Informational intervention (mailed information)
• Sending reminder postcards, illustrated daily medication schedule distribution
• Counseling on the importance of adherence to their cardiovascular medication and review of each medication during the hospital stay
• Clinical pharmacist intervention with medication reconciliation, medication education, facilitation of the delivery of discharge medications, and post-discharge telephone call within 48-72h These interventions showed an impact on long-term medication adherence and health literacy, which could lead to an improvement of the morbi-mortality of cardiovascular risk patients.

In a previous study conducted at the University hospital of Lausanne, the investigators showed a very high prescription rate of guidelines-recommended medications for patients involved in the CHUV STEMI (ST-Elevation Myocardial Infarction) network. Therefore, the next step to reduce the morbi-mortality of high-risk cardiovascular patients is to enhance patient adherence to the cardiovascular drug regimen. Patient education is known as an effective process to enhance drug adherence. Unfortunately, patient education is difficult to implement because of it costs and for the time needed to educate the patient. The investigator's aim at testing a new approach using an e-learning tool for patient education purpose. The e-learning will be interactive and easy to use. It will inform the patient about his heart disease (acute coronary syndrome) and about his medications in a short time.

Conditions

Acute Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

BASIC

"mon cœur, mon BASIC" video viewing and installation in the own smartphone or tablet of the patient

Group Type: EXPERIMENTAL

E-learning

Intervention Type: OTHER

The intervention consists of the presentation and installation of an internet tool to educate the patient about his heart condition and about his medications in addition to usual care. The tool is an interactive web-hosting video called "Mon Coeur, mon BASIC" adaptable to smartphones and tablets. The total length of the video is around 15 minutes. The e-learning is interactive because of the possibility to click in the video to have more details about a particular point. The tool includes a part about the heart and particularly about the ACS (physiopathology, diagnosis, coronarography, angioplasty). A second part includes an education about the medications prescribed. The patient will select the medication being prescribed and receive information about it.

Control

Usual care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

E-learning

The intervention consists of the presentation and installation of an internet tool to educate the patient about his heart condition and about his medications in addition to usual care. The tool is an interactive web-hosting video called "Mon Coeur, mon BASIC" adaptable to smartphones and tablets. The total length of the video is around 15 minutes. The e-learning is interactive because of the possibility to click in the video to have more details about a particular point. The tool includes a part about the heart and particularly about the ACS (physiopathology, diagnosis, coronarography, angioplasty). A second part includes an education about the medications prescribed. The patient will select the medication being prescribed and receive information about it.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Admission for acute coronary syndrome (ACS) in the cardiology unit of the University hospital of Lausanne (NSTEMI or STEMI)
• Have a percutaneous coronary intervention (PCI) as therapeutic strategy
• Patients going through an elective PCI for a second vessel after having suffered from an acute coronary syndrome in the previous month
• > 18 years
• Total discernment capacity and French speaking
• Have a digital tablet, a smartphone or a computer to have the possibility to watch the e-learning at home
• Informed Consent as documented by signature (Appendix Informed Consent Form)

Exclusion Criteria

• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
• Refugee claimants, homeless persons, prisoners by impossibility to contact them after discharge
• Patients with communication problems
• Life expectancy < 6 months caused by other co-morbidities

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Lausanne Hospitals

OTHER

Sponsor Role: lead

Responsible Party

Christel Bruggmann

PhD student and clinical pharmacist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christel Bruggmann, PharmD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire Vaudois (CHUV)

Locations

Centre Hsopitalier Universitaire Vaudois

Lausanne, , Switzerland

Countries

Switzerland

References

Bruggmann C, Adjedj J, Sardy S, Muller O, Voirol P, Sadeghipour F. Effects of the Interactive Web-Based Video "Mon Coeur, Mon BASIC" on Drug Adherence of Patients With Myocardial Infarction: Randomized Controlled Trial. J Med Internet Res. 2021 Aug 30;23(8):e21938. doi: 10.2196/21938.

Reference Type: DERIVED

PMID: 34459744 (View on PubMed)

Other Identifiers

2018-02223

Identifier Type: -

Identifier Source: org_study_id