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Randomized, Single Center Study About the Impact of an E-learning Dedicated to Myocardial Infarction Patient
| 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 |
| Allocation: | Randomized |
| 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 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: BASIC
"mon cœur, mon BASIC" video viewing and installation in the own smartphone or tablet of the patient
|
Other: E-learning
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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|
No Intervention: Control
Usual care
|
- 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.
| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
| Switzerland | |
| Centre Hsopitalier Universitaire Vaudois | |
| Lausanne, Switzerland, 1011 | |
| Principal Investigator: | Christel Bruggmann, PharmD | Centre Hospitalier Universitaire Vaudois (CHUV) |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 25, 2019 | ||||
| First Posted Date ICMJE | May 14, 2019 | ||||
| Last Update Posted Date | September 25, 2020 | ||||
| Actual Study Start Date ICMJE | February 4, 2019 | ||||
| Actual Primary Completion Date | March 22, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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.
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Randomized, Single Center Study About the Impact of an E-learning Dedicated to Myocardial Infarction Patient | ||||
| Official Title ICMJE | Randomized, Single Center Study About the Impact of an E-learning Dedicated to Myocardial Infarction Patient | ||||
| 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:
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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized 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 |
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| Condition ICMJE | Acute Myocardial Infarction | ||||
| Intervention ICMJE | Other: E-learning
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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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE |
67 | ||||
| Original Estimated Enrollment ICMJE |
120 | ||||
| Actual Study Completion Date ICMJE | July 15, 2020 | ||||
| Actual Primary Completion Date | March 22, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | Child, Adult, Older Adult | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Switzerland | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03949608 | ||||
| Other Study ID Numbers ICMJE | 2018-02223 | ||||
| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Christel Bruggmann, University of Lausanne Hospitals | ||||
| Study Sponsor ICMJE | University of Lausanne Hospitals | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | University of Lausanne Hospitals | ||||
| Verification Date | September 2020 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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