A Study to Evaluate the Impact of Long-term Digital Education vs Standard of Care on LDL-C Levels in Post Myocardial Infarction Patients
NCT Number: NCT06548555
Acronym: DEDUCA-CZ
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Myocardial Infarction
Interventions: OTHER: systematic educational intervention
Sponsor: Novartis Pharmaceuticals
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-03-08
Completion Date: 2024-10-31
Locations: Novartis Investigative Site, Brno Bohunice, 625 00, Czechia|Novartis Investigative Site, Ceske Budejovice, 370 01, Czechia|Novartis Investigative Site, Ostrava Poruba, 708 52, Czechia|Novartis Investigative Site, Praha, 12808, Czechia|Novartis Investigative Site, Praha, 150 30, Czechia

Summary:
The purpose of this study is to demonstrate the impact of digital education on the cardiovascular risk factors in post-Myocardial Infarction patients and to generate evidence for broad implementation of the proposed education program.

Primary Outcome Measures: Absolute change in LDL-C levels from baseline at month 12, Absolute change in LDL-C levels from baseline at month 12 after the event., Baseline, month 12|Relative (percentage) change in LDL-C levels from baseline at month 12, Relative change in LDL-C levels from baseline at month 12 after the event., Baseline, month 12
Secondary Outcome Measures: Percentage of patients achieving their LDL-C target level, Percentage of patients achieving their LDL-C target level according to the 2019 ESC/EAS Guidelines (LDL-C reduction of ≥50% from baseline and an LDL-C goal of \<1.4 mmol/L), Month 12|Change in total cholesterol from Baseline at Month 12, Change in total cholesterol from Baseline at Month 12, Baseline, month 12|Change in HDL-C from Baseline at month 12, Change in high-density lipoprotein cholesterol (HDL-C), Baseline, month 12|Change in VLDL-C from Baseline at month 12, Change in very low- density lipoprotein cholesterol (VLDL-C)., Baseline, month 12|Change in non-HDL-C from Baseline at month 12, Change in non-high-density lipoprotein cholesterol (non-HDL-C)., Baseline, month 12|Change in triglycerides from Baseline at month 12, Change in triglycerides, Baseline, month 12|Change in Lp(a) from Baseline at month 12, Change in lipoprotein(a) \[Lp(a)\]), Baseline, month 12|Blood pressure, Blood pressure at baseline and month 12 will be provided, Baseline, month 12|Body Mass Index, BMI (Body Mass Index) at baseline and month 12 will be provided, Baseline, month 12|Waist circumference, Waist circumference at baseline and month 12 will be provided, Baseline, month 12|Number of patients smoking, Number of patients smoking at Baseline and at Month 12, Baseline, month 12|Number of cigarettes smoked per week, Number of cigarettes smoked per week at Baseline and at Month 12, Baseline, month 12|percentage of patients that have ceased smoking by Month 12, percentage of patients that have ceased smoking by Month 12 after the event., Month 12|Percentage of patients that have changed their diet according to the recommendations, Percentage of patients that have changed their diet according to the recommendations (such as increasing consumption of vegetables, fruits, whole grains, fish; reducing intake of trans-fats, sweets, sugar-added beverages and red meat) by Month 12 after the event., month 12|Average number of units of alcohol consumed daily, Average number of units of alcohol consumed daily at Baseline and at Month 12, Baseline, month 12|Percentage of patients that have decreased their alcohol intake, Percentage of patients that have decreased their alcohol intake by Month 12 after the event., month 12|Average estimated time spent by physical activities per week, Average estimated time spent by physical activities per week, Baseline, month 12|Average number of steps walked daily, average number of steps walked daily at Baseline and Month 12., Baseline, month 12|Percentage of patients that have increased their physical activity, Percentage of patients that have increased their physical activity by Month 12 after the event., 12 months|Percentage of patients who registered at a cardiologist during the study, Percentage of patients who registered at a cardiologist during the study, 12 months|Percentage of patients adherent to statin therapy, Percentage of patients adherent to statin therapy at baseline and at Month 12 in both arms. Adherence is defined as taking medications as prescribed \>75% of the time based on responses to Gehi et al. adherence question ("In the past month, how often did you take statins as the doctor prescribed?") on Month 12, Baseline, month 12|Number of participants by living conditions- family conditions, Living conditions- family conditions: marital status, number of children; place of residency (urban/rural), Baseline|Lipid profile, Lipid profile (LDL-C, total cholesterol, HDL-C, VLDL-C, non-HDL-C and triglycerides)., Baseline, month 12|Lipid profile - Lp(a), Lp(a) values at Baseline and month 12 will be provided, Baseline, month 12|Number of participants with comorbidities, Comorbidities (diabetes mellitus, chronic kidney disease) at Baseline, Baseline|Number of participants that manifest ASCVD in family history, Number of participants that manifest ASCVD in family history, Baseline|Number of participants by MI pharmacological treatment, Number of participants by Myocardial Infarction (MI) pharmacological treatment, 12 months|Percentage of patients treated with PCSK9 antibodies to patients eligible for PCSK9 antibodies, Percentage of patients treated with PCSK9 antibodies to patients eligible for PCSK9 antibodies (according to the Czech reimbursement criteria)., 12 months