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

NCT07382414 | Not Yet Recruiting

• 1 other identifier: NUDGE-IHD
• Study Type: interventional
• Target: 100,000
• Locations: 1 country
• Sites: 1

Brief 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

Coronary Artery Disease; Hypercholesterolemia; Lipoprotein(a); Secondary Prevention

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Number of healthcare contacts (general practice or outpatient hospital) within 6 months following randomization

  6 months after randomization

• At least one cardiometabolic blood test

  Within 6 months after randomization

Study Arms (4)

LDL letter only

EXPERIMENTAL

Participants randomized to the LDL-C letter but not the Lp(a) letter

Behavioral: LDL-C information letter

Lp(a) letter only

EXPERIMENTAL

Participants randomized to the Lp(a) letter but not the LDL-C letter.

Behavioral: Lp(a) information 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

Behavioral: LDL-C information letter; Behavioral: Lp(a) information letter

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.

LDL letter only; LDL-C and Lp(a) letter

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.

LDL-C and Lp(a) letter; Lp(a) letter only

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Alive on identification date
• Diagnosis of IHD defined as either an A or B diagnosis code of I20-I25 in the Danish National Patient Register first registered \> 6 months prior to identification date
• 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 on identification date

You may not qualify if:

• Nursing home residents
• Exemption from and thus not access to Digital Post

Sponsors & Collaborators

• Tor Biering-Sørensen: lead
• Novartis: collaborator

Study Sites (1)

Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte, Hellerup, 2900

Hellerup, Region Sjælland, 2900, Denmark

Location

MeSH Terms

Conditions

Coronary Artery Disease; Hypercholesterolemia

Interventions

Apolipoproteins A

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Apolipoproteins; Lipoproteins; Lipids; Apoproteins; Proteins; Amino Acids, Peptides, and Proteins

Central Study Contacts

Tor Biering-Sørensen, MD, MPH, MSc, PhD

CONTACT

28933590; tor.biering-soerensen@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, MD, MSc, MPH, PhD

Model Details: Pragmatic, registry-based partial 2×2 factorial design.

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: February 2, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)