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Acute Myocardial InfarctionNCT03949608

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

A study testing E-learning in people with Acute Myocardial Infarction, run by University of Lausanne Hospitals at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Acute Myocardial Infarction
What is being tested?
E-learning
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
67 participants
Where
1 siteSwitzerland
Study dates
4 Feb 2019to 15 Jul 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Centre Hsopitalier Universitaire Vaudois

    Lausanne, 1011

Other trials in Switzerland

About this study

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.

Read the 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.

Being tested
E-learning
Keywords
e-learning, drug adherence, health literacy
Medical subject headings
Medication Adherence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • E-learningOther

    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.

Study groups in NCT03949608
Study groupRoleWhat they receive
BASICExperimental"mon cœur, mon BASIC" video viewing and installation in the own smartphone or tablet of the patient
Receives: Other: E-learning
ControlNo interventionUsual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ARMS (Adherence to Refill and Medication Score) score difference

    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.

    Measured: 1,3 and 6 months

Secondary outcomes (5)

  1. Knowledge about the disease and medications

    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.

    Measured: 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

  2. LDL-c measurement

    Difference in LDL-c measurements from discharge to 3 months

    Measured: 3 months

  3. BMI

    Difference in BMI from discharge to 6 months

    Measured: 6 months

  4. Target Blood Pressure

    proportion of patients being in the target blood pressure measurements at 6 months

    Measured: 6 months

  5. composite endpoint of readmission, reinfarction or emergency visit

    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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2019
  2. Study start4 Feb 2019
  3. Primary completion22 Mar 2020
  4. Study completion15 Jul 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Sequential
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)
Enrolment
67 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03949608
Sponsor's protocol ID
2018-02223
Other IDs
2018
Status last verified
Sep 2020
First submitted
25 Apr 2019
Last updated
25 Sep 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 34459744

Questions about this trial

What is this clinical trial studying?

A study testing E-learning in people with Acute Myocardial Infarction, run by University of Lausanne Hospitals at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ARMS (Adherence to Refill and Medication Score) score difference (time frame: 1,3 and 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03949608, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2020.

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