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

NCT07382414 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100000

Last updated 2026-03-10

No results posted yet for this study

Summary

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.

Conditions

Interventions

BEHAVIORAL

LDL-C information letter

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.

BEHAVIORAL

Lp(a) information letter

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.

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY
  • Tor Biering-Sørensen

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2026-10-31
Completion
2026-10-31

Countries

  • Denmark

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07382414 on ClinicalTrials.gov