NCT07382414Not yet recruiting
Electronic Letters to Improve Patient Activation in IHD: The NUDGE-IHD Trial
NUDGE-IHD: A Nationwide Pragmatic Randomized Trial of Electronic Nudges to Increase Patient Activation and Reduce Cardiovascular Events in Ischemic Heart Disease
Source: ClinicalTrials.gov · Last updated 8 Sept 2026
Brief summary (registry, in English)
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: * Does sending an electronic letter about elevated LDL cholesterol increase the proportion of patients who have at least one LDL-cholesterol test within 6 months? * Does sending an electronic letter about elevated LDL cholesterol reduce major adverse cardiovascular events (cardiovascular death, myocardial infarction, or stroke) over 5 years? * Among patients with ischemic heart disease and elevated Lp(a), does receiving an information letter about Lp(a) increase the proportion who have at least one LDL-cholesterol test within 6 months, and does it reduce major adverse cardiovascular events over 5 years? 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: * Receive an electronic letter through Denmark's national digital mailbox system (Digital Post) or receive no letter, depending on random assignment. * Continue their usual health care, with no additional visits, treatments, or procedures required for the study. * Have all study information collected from existing Danish nationwide health registries.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 123000 (estimated)
- First submitted
- 9 Dec 2025
- Start date
- Sept 2026
- Primary completion date
- Sept 2031
- Lead sponsor
- Tor Biering-Sørensen
- NCT number
- NCT07382414
What you commit to
- Study type: Interventional
- Planned participants: 123000
- From Sept 2026 to the primary completion date, Sept 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- Exemption from, and thus no access to, Digital Post
- Definition of the elevated Lp(a) subgroup (secondary study population) Participants in the primary study population who, in addition, have an elevated Lp(a) level recorded at any time prior to the identification date, identified in the Danish National Laboratory Register using NPU codes NPU21687 or NPU19840. Elevated Lp(a) is defined as \>= 105 nmol/L or \>= 50 mg/dL. Only participants in this subgroup undergo the second randomization to the Lp(a) letter.
Other
- Nursing home residents
Who the study is looking for
- Alive and resident in Denmark on the identification date
- Diagnosis of IHD defined as an A (action) diagnosis code of I20-I25 in the Danish National Patient Register, first registered \> 6 months prior to the identification date but after January 1, 2000
- Latest available LDL-C is over 1.4 mmol/l measured up to 3 years prior to the identification date, defined using NPU codes NPU01568, NPU10171 or DNK35308 from the Danish National Laboratory Register
- Age \>= 18 years and \<= 85 years on the identification date
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte, Hellerup, 2900 Coordinator of this site? Confirm its status | Hellerup | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.