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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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The goal of this clinical trial is to learn whether simple electronic information letters can increase patient activation and improve risk-factor monitoring in adults in Denmark with ischemic heart disease (IHD) who have LDL cholesterol above the recommended treatment target. A subgroup of participants with elevated lipoprotein(a) [Lp(a)] will also be randomized to receive an additional information letter.
The main questions the study aims to answer are:
Because this is a randomized trial, researchers will compare people who receive the electronic letter(s) with people who do not receive any letter to determine whether the letters encourage patients to take action, such as obtaining laboratory tests or contacting their doctor.
Participants will:
This study is a nationwide, pragmatic, registry-based, partially factorial randomized trial conducted in Denmark. The trial evaluates whether simple electronic information letters ("nudges") can increase patient activation and support guideline-directed risk-factor monitoring among persons with ischemic heart disease (IHD) who have LDL cholesterol levels above guideline-recommended treatment targets in routine clinical care.
The primary study population consists of adults with documented ischemic heart disease and LDL cholesterol above the recommended target level. Eligible participants are identified using Danish nationwide health registries and randomized 1:1 to receive either an electronic information letter addressing elevated LDL cholesterol (the "LDL letter") or no letter. The LDL letter provides general, non-technical information about LDL cholesterol as a cardiovascular risk factor in ischemic heart disease and encourages recipients to consult their physician if relevant.
A secondary study population is defined as a subset of the primary population with elevated lipoprotein(a) [Lp(a)] levels identified from laboratory registry data. Participants in this subgroup are independently randomized 1:1 to receive or not receive an additional electronic information letter addressing elevated Lp(a) (the "Lp(a) letter"). The Lp(a) letter provides information on Lp(a) as a genetically determined and independent cardiovascular risk factor and emphasizes the importance of optimizing other modifiable risk factors. The two randomizations are conducted independently, resulting in a partially factorial design in which participants with elevated Lp(a) may receive no letter, the LDL letter only, the Lp(a) letter only, or both letters.
All intervention letters are delivered through Denmark's mandatory national digital mailbox system (Digital Post). The interventions are informational and non-invasive. The study does not involve any in-person visits, clinical procedures, or changes to usual medical care.
The primary outcome is disease-related patient activation, defined as the proportion of participants with at least one LDL cholesterol measurement recorded within 6 months after randomization. Secondary outcomes include general patient activation, assessed by the number of healthcare contacts in general practice or outpatient hospital settings, and cardiometabolic risk-factor monitoring, defined as the proportion of participants with at least one cardiometabolic blood test (lipid profile, hemoglobin A1c, or creatinine) within 6 months after randomization. Additional exploratory outcomes related to laboratory testing, healthcare utilization, medication use, and clinical events are assessed during longer-term follow-up.
All baseline characteristics, outcomes, and follow-up data are obtained from Danish nationwide health and administrative registries. Due to the registry-based and informational nature of the interventions, informed consent is not required. The primary analysis is conducted 6 months after randomization, with additional exploratory follow-up extending up to 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LDL letter only | Experimental | Participants randomized to the LDL-C letter but not the Lp(a) letter |
|
| Lp(a) letter only | Experimental | Participants randomized to the Lp(a) letter but not the LDL-C letter. |
|
| No letter | No Intervention | Participants randomized to no LDL-C letter and to no Lp(a) letter | |
| LDL-C and Lp(a) letter | Experimental | Participants randomized to the LDL-C letter and the Lp(a) letter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LDL-C information letter | Behavioral | An electronically delivered informational letter communicating the participant's elevated LDL-C level and its relevance to ASCVD, with encouragement to consult their physician if relevant. Delivered via the Danish Digital Post system. |
| Measure | Description | Time Frame |
|---|---|---|
| the proportion of participants with at least one LDL-C measurement within 6 months following randomization | Whether the participant has at least one LDL-C laboratory measurement recorded in the Danish national laboratory registries within 6 months after randomization | 6 months after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Number of healthcare contacts (general practice or outpatient hospital) within 6 months following randomization | Total number of healthcare contacts, defined as general practice contacts (in-person, telephone, or electronic) or outpatient hospital visits, recorded in national registries within 6 months after randomization. | 6 months after randomization |
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Inclusion criteria
Exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tor Biering-Sørensen, MD, MPH, MSc, PhD | Contact | 28933590 | +45 | tor.biering-soerensen@regionh.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte, Hellerup, 2900 | Hellerup | Region Sjælland | 2900 | Denmark |
Data will be collected from Danish administrative health registries, which are subject to Danish legislation and can only be made available to a third party under certain conditions. Please contact the sponsor-investigator in case of any inquiries.
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D001054 | Apolipoproteins A |
| ID | Term |
|---|---|
| D001053 | Apolipoproteins |
| D008074 | Lipoproteins |
| D008055 | Lipids |
| D001059 | Apoproteins |
| D011506 |
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Pragmatic, registry-based partial 2×2 factorial design.
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| Lp(a) information letter | Behavioral | An electronically delivered informational letter describing elevated Lp(a) as a genetically determined cardiovascular risk factor, with encouragement to discuss risk factor optimization with a physician if relevant. |
|
| At least one cardiometabolic blood test | Proportion of participants with at least one cardiometabolic blood test (lipid profile, hemoglobin A1c, or creatinine) recorded in Danish nationwide laboratory registries during follow-up. | Within 6 months after randomization |
|
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |