Randomized, Single Center Study About the Impact of an E-learning Dedicated to Myocardial Infarction Patient
|ClinicalTrials.gov Identifier: NCT03949608|
Recruitment Status : Completed
First Posted : May 14, 2019
Last Update Posted : September 25, 2020
|Condition or disease||Intervention/treatment||Phase|
|Acute Myocardial Infarction||Other: E-learning||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||67 participants|
|Intervention Model:||Sequential Assignment|
|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|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Randomized, Single Center Study About the Impact of an E-learning Dedicated to Myocardial Infarction Patient|
|Actual Study Start Date :||February 4, 2019|
|Actual Primary Completion Date :||March 22, 2020|
|Actual Study Completion Date :||July 15, 2020|
"mon cœur, mon BASIC" video viewing and installation in the own smartphone or tablet of the patient
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.
No Intervention: Control
- ARMS (Adherence to Refill and Medication Score) score difference [ Time Frame: 1,3 and 6 months ]Adherence to Refill and Medication Score is a self-reported questionnaire with 12-items. 8 items assess adherence to taking medications, and 4 items assess the refill to medication. The results can vary from 12 (most adherent) to 48 (less adherent). The ARMS questionnaire will be assessed after 1 month, 3 months and 6 months. We will assess the difference in the mean ARMS score between control group and intervention group at these 3 timepoints.
- Knowledge about the disease and medications [ Time Frame: 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 ]Difference in a knowledge score assessed with a 9 multiple choice questions about the disease (examples: what is a coronary artery? What happens during an acute myocardial infarction? Which medication is used to reduce cholesterol level?). The maximum score is 9 and the minimum is 0. The mean score will be tested between intervention and control group. The score variation will be assessed during time after ACS.
- LDL-c measurement [ Time Frame: 3 months ]Difference in LDL-c measurements from discharge to 3 months
- BMI [ Time Frame: 6 months ]Difference in BMI from discharge to 6 months
- Target Blood Pressure [ Time Frame: 6 months ]proportion of patients being in the target blood pressure measurements at 6 months
- composite endpoint of readmission, reinfarction or emergency visit [ Time Frame: 6 months ]Readmissions, reinfarction and emergency visit will be assessed with a questionnaire at 6 months. We will assess if there is a difference between intervention and control group.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03949608
|Centre Hsopitalier Universitaire Vaudois|
|Lausanne, Switzerland, 1011|
|Principal Investigator:||Christel Bruggmann, PharmD||Centre Hospitalier Universitaire Vaudois (CHUV)|