Clinical trial NCT03949608: Randomized, Single Center Study About the Impact of an E-learning Dedicated to Myocardial Infarction Patient
Official title: Randomized, Single Center Study About the Impact of an E-learning Dedicated to Myocardial Infarction Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Myocardial Infarction
Keywords: e-learning
drug adherence
health literacy
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
First posted: 2019-05-14
Enrollment: 67
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: We will randomize patients by block of 2 weeks of inclusion in intervention or controlled group. Each 2 weeks, all participants will be included in the intervention group, and the next 2 weeks the participants will be included in the control group
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: ARMS (Adherence to Refill and Medication Score) score difference
timeFrame: 1,3 and 6 months
Secondary outcomes:
measure: Knowledge about the disease and medications
timeFrame: at time of inclusion, 1 day after inclusion for control group and after the viewing of the video for the intervention group, 1 month, 3 months and 6 months
measure: LDL-c measurement
timeFrame: 3 months
measure: BMI
timeFrame: 6 months
measure: Target Blood Pressure
timeFrame: 6 months
measure: composite endpoint of readmission, reinfarction or emergency visit
timeFrame: 6 months
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Centre Hsopitalier Universitaire Vaudois
Study officials:
affiliation: Centre Hospitalier Universitaire Vaudois (CHUV)
name: Christel Bruggmann, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.