- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03949608
Randomized, Single Center Study About the Impact of an E-learning Dedicated to Myocardial Infarction Patient
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Lausanne, Suiza, 1011
- Centre Hsopitalier Universitaire Vaudois
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación Secuencial
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Sin intervención: Control
Cuidado usual
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Experimental: BASIC
"mon cœur, mon BASIC" video viewing and installation in the own smartphone or tablet of the patient
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
ARMS (Adherence to Refill and Medication Score) score difference
Periodo de tiempo: 1,3 and 6 months
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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.
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1,3 and 6 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Knowledge about the disease and medications
Periodo de tiempo: 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
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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.
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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
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LDL-c measurement
Periodo de tiempo: 3 months
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Difference in LDL-c measurements from discharge to 3 months
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3 months
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BMI
Periodo de tiempo: 6 months
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Difference in BMI from discharge to 6 months
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6 months
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Target Blood Pressure
Periodo de tiempo: 6 months
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proportion of patients being in the target blood pressure measurements at 6 months
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6 months
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composite endpoint of readmission, reinfarction or emergency visit
Periodo de tiempo: 6 months
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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.
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6 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Christel Bruggmann, PharmD, Centre Hospitalier Universitaire Vaudois (CHUV)
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2018-02223
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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