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

Sponsor
Tor Biering-Sørensen
Study ID
NCT07382414
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • 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.

Study Details

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? * Among patients with ischemic heart disease and elevated Lp(a), does receiving an information letter about Lp(a) increase patient activation, reflected by cardiometabolic risk-factor monitoring? 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.

Key Dates

First listed
Feb 2, 2026
Start date
Apr 30, 2026
Status verified
Jan 2026
Primary completion
Oct 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
100,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: LDL letter only
    Participants randomized to the LDL-C letter but not the Lp(a) letter
  • Experimental: Lp(a) letter only
    Participants randomized to the Lp(a) letter but not the LDL-C letter.
  • No Intervention: No letter
    Participants randomized to no LDL-C letter and to no Lp(a) letter
  • Experimental: LDL-C and Lp(a) letter
    Participants randomized to the LDL-C letter and the Lp(a) letter

Primary Outcome Measure

the proportion of participants with at least one LDL-C measurement within 6 months following randomization [ Time Frame: 6 months after randomization ]

Central Contacts

Related Studies