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

NCT03949608 | Completed DMC

• 1 other identifier: 2018-02223
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myocardial Infarction

Keywords

e-learning; drug adherence; health literacy

Outcome Measures

Primary Outcomes (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.

  1,3 and 6 months

Secondary Outcomes (5)

• Knowledge about the disease and medications

  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

• LDL-c measurement

  3 months

• BMI

  6 months

• Target Blood Pressure

  6 months

• composite endpoint of readmission, reinfarction or emergency visit

  6 months

Study Arms (2)

BASIC

EXPERIMENTAL

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

Other: E-learning

Control

NO INTERVENTION

Usual care

Interventions

E-learning 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.

BASIC

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Lausanne Hospitals: lead

Study Sites (1)

Centre Hsopitalier Universitaire Vaudois

Lausanne, 1011, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 34459744 DERIVED

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Christel Bruggmann, PharmD

  Centre Hospitalier Universitaire Vaudois (CHUV)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student and clinical pharmacist

Model Details: 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

Study Record Dates

• First Submitted: April 25, 2019
• First Posted: May 14, 2019
• Study Start: February 4, 2019
• Primary Completion: March 22, 2020
• Study Completion: July 15, 2020
• Last Updated: September 25, 2020

Record last verified: 2020-09

Locations

CH (1)