Atherosclerotic Cardiovascular Disease
Conditions
Keywords
Dyslipidemia,, ASCVD,, lipid optimization program,, LDL-C target,, educational intervention,, hybrid effectiveness-implementation study
Brief summary
This study is an open label, randomized, prospective, type I hybrid effectiveness- implementation, pragmatic clinical trial to evaluate the impact of a targeted lipid optimization program on LDL-C control in participants with dyslipidemia who are at high risk or very high risk of cardiovascular events.
Detailed description
The treatment of interest is a lipid optimization program in the form of a health education intervention delivered via clinic visits (every 4 months) and virtual sessions (between each clinic visit). No active drug treatment will be provided. The intervention in this study will involve the implementation of a lipid optimization, education program for patients at high risk and very high risk of cardiovascular events.
Interventions
OTHEREducational Material
Health Education Intervention delivered via clinic visits (every 4 months) and virtual sessions (between each clinic visit)
OTHERStandard of care
Standard of care
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of ASCVD (coronary heart disease, peripheral arterial disease and/or cerebrovascular disease) * High risk or very high risk for cardiovascular events (as per the 2019 ESC/EAS guidelines \[1\] for the management of dyslipidemias) * Lipid levels: * High risk: LDL-C ≥70 mg/dl (or \> 1.8 mmol/L) or non-HDL-C ≥100 mg/dl * Very high risk: LDL-C ≥55 mg/dl (or \> 1.4 mmol/L) or non-HDL-C ≥85 mg/dl * Male or Female * 18 years or older * Seen by a specialist who is prescribing advanced lipid lowering treatments (LLTs) (cardiologist, endocrinologist or any other relevant specialist) * Currently taking maximum-tolerated statins * Ability to participate in educational program (must be able to watch online videos) * Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Exclusion criteria
* Any surgical or medical condition, which in the opinion of the Investigator, may place the participant at higher risk from his/her participation in the study, or is likely to prevent the participant from complying with the requirements of the study or completing the study. * Unwillingness or inability (e.g., physical or cognitive) to comply with study procedures (including adherence to study visits). * Participation in any other interventional study. * Inability to travel to study sites for in-person clinic visits. * Responsible physician clinical decision not to engage the identified patient. * Refusal of the potential participant to sign the consent and be included in the model. Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants achieving target LDL-C goals based on CV risk | Baseline, month 12 | Percentage of participants achieving target Low-Density Lipoprotein Cholesterol (LDL-C) goals based on Cardiovascular (CV) risk stratified by group: * Very high risk: \<55 mg/dl * High risk: \<70 mg/dl |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants achieving or maintaining target LDL-C goals based on CV risk | Baseline, month 24 | Percentage of participants achieving or maintaining target Low-Density Lipoprotein Cholesterol (LDL-C) goals based on Cardiovascular (CV) risk stratified by group: * Very high risk: \<55 mg/dl * High risk: \<70 mg/dl |
| Change of LDL-C | Baseline, month 12 and month 24 | Change of Low-Density Lipoprotein Cholesterol (LDL-C) from baseline at 12 months and 24 months in both study groups |
| Change in the proportion of participants receiving advanced lipid lowering therapies | Month 12 and Month 24 | Change in the proportion of participants receiving advanced lipid lowering therapies at 12 months and 24 months from baseline, for each group |
| Proportion of participants from the intervention group who complete all visits | 24 months | Proportion of participants from the intervention group who complete all: * In clinic visits * Virtual sessions |
| Proportion of participants from the intervention group who discontinue the education program | 12 months | Proportion of participants from the intervention group who discontinue the education program before the 12 month study visit |
| Proportion of days covered | Baseline, month 12 and month 24 | Proportion of days covered (for statins and non-statin lipid therapies) |
| Number of hospitalizations | 24 months | Number of hospitalizations during the 12 month active intervention period and the 12 month follow up period |
| Number of outpatient visits | 24 months | Number of outpatient visits during the 12 month active intervention period and the 12 month follow up period |
| Number of ER visits | 24 months | Number of Emergency Room (ER) visits during the 12 month active intervention period and the 12 month follow up period |
| Associated costs | 24 months | Associated costs during the 12 month active intervention period and the 12 month follow up period |
| Number of LDL-C tests performed | 24 months | Number of Low-Density Lipoprotein Cholesterol (LDL-C) tests performed, analyzed according to: * Site (clinic) * Healthcare Professional (HCP) specialty (Cardiologists, Endocrinologists, internist, etc.) * Baseline characteristics (e.g. age, sex, ethnicity, Cardiovascular risk status) |
| Change in knowledge awareness scores: | Baseline, month 12 and month 24 | Awareness regarding lipid management amongst those participants in the intervention group will be measured using a knowledge awareness questionnaire. The same questionnaire will be administered at baseline, 12 months and 24 months, enabling scores to be compared across the study duration. The knowledge awareness questionnaire scale has a minimum score of 0 and maximum score of 17 points. A high score will indicate higher participant awareness. |
| Change in WHO BREF quality of life scores | Baseline, month 12 and month 24 | WHO BREF questionnaire assesses QoL across four main domains: physical health, psychological health, social relationships, and environmental health. Participants will respond to each item using a Likert scale (ranging from 1 to 5) indicating their level of agreement or satisfaction. Higher scores typically indicate better QoL. |
| Qualitative surveys among focus groups of HCPs and participants to evaluate implementation outcomes | month 12 and month 24 | Implementability of the lipid optimization program will be assessed during focus group sessions that explore satisfaction, costs, and acceptance of the program from the perspective of HCPs and participants |
Countries
United Arab Emirates
Contacts
CONTACTNovartis Pharmaceuticals
STUDY_DIRECTORNovartis Pharmaceuticals
Novartis Pharmaceuticals
Outcome results
None listed