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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorTor Biering-Sørensen

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Nursing home residents

Exemption from, and thus no access to, Digital Post

Trial design

Design model

Factorial

Treatments tested in this trial

  • LDL-C information letter

    Behavioral

    An electronically delivered informational letter communicating the participant's elevated LDL-C level and its relevance to IHD, 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.

Treatment groups

123,000 Participants
are divided into 4 treatment groups
Group A: LDL letter onlyExperimental treatment 1 intervention
Group B: Lp(a) letter onlyExperimental treatment 1 intervention
Group C: No letterNo intervention 0 interventions
Group D: LDL-C and Lp(a) letterExperimental treatment 2 interventions

Trial outcomes

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

Time frame
6 months after randomization
2

Proportion of participants experiencing a major adverse cardiovascular event (MACE) within 5 years following randomization

Proportion of participants experiencing a major adverse cardiovascular event, defined as the composite of cardiovascular death, myocardial infarction, or stroke, ascertained from Danish nationwide health and administrative registries within 5 years after randomization.

Time frame
5 years after randomization

Secondary outcomes

1

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

Total number of healthcare contacts, defined as general practice contacts (in-person, telephone, or electronic) or outpatient hospital visits, recorded in national registries within 6 months after randomization.

Time frame
6 months after randomization
2

At least one cardiometabolic blood test

Proportion of participants with at least one cardiometabolic blood test (lipid profile, hemoglobin A1c, or creatinine) recorded in Danish nationwide laboratory registries within 6 months after randomization.

Time frame
Within 6 months after randomization

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tor Biering-Sørensen

Lead sponsor

Herlev and Gentofte Hospital

Sponsor institution

Novartis

Collaborator

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