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? * 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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Nursing home residents

Exemption from and thus not access to Digital Post

Trial design

Treatments tested in this trial

  • LDL-C information letter
  • Lp(a) information letter

Treatment groups

100,000 Participants
are divided into 4 treatment groups

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 collaborators

Tor Biering-Sørensen

Lead sponsor

Herlev and Gentofte Hospital

Sponsor institution

Novartis

Collaborator