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Electronic Letters to Improve Patient Activation in IHD: The NUDGE-IHD Trial

Study acronym: NUDGE-IHD
StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 4 years 10 months later Oct 2026 → Sep 2031
Primary endpoint added 1 → 2 primary endpoints
See other at-risk trials from Tor Biering-Sørensen

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary and study completion pushed from Oct 2026 to Sep 2031v3 Show 6 more changesShow less
    • Primary endpoint(s) modified
    • Start date: Apr 2026 to Sep 2026
    • Enrollment increased: 100000 → 123000 participants
    • Eligibility criteria expanded, about 84 words
    • Secondary endpoints: details revised at 1 of 2 entries
    • Study description expanded, about 85 words
  2. Minor Re-verified, no change to tracked fieldsv2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07382414
Lead Sponsor Tor Biering-Sørensen
Collaborators: Novartis
Conditions
(from sponsor)
Ischemic Heart Disease, Coronary Artery Disease, Hypercholesterolemia, Lipoprotein(a), Secondary Prevention
Related terms Coronary Artery Disease, Hypercholesterolemia, Myocardial Ischemia
Enrollment 123,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov