Набор скоро начнётся NCT07382414

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

Без фазы С лечением Coronary Artery Disease Hypercholesterolemia Lipoprotein(a) Secondary Prevention

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: LDL-C information letter, Lp(a) information letter.
Кому может быть актуально: Состояния в реестре: Coronary Artery Disease, Hypercholesterolemia, Lipoprotein(a), Secondary Prevention. Базовые параметры: 18 лет — 85 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Дания
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

NUDGE-IHD: A Nationwide Pragmatic Randomized Trial of Electronic Nudges to Increase Patient Activation to Support Risk-factor Control in Ischemic Heart Disease

Обзор

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.

Подробное описание

This study is a nationwide, pragmatic, registry-based, partially factorial randomized trial conducted in Denmark. The trial evaluates whether simple electronic information letters ("nudges") can increase patient activation and support guideline-directed risk-factor monitoring among persons with ischemic heart disease (IHD) who have LDL cholesterol levels above guideline-recommended treatment targets in routine clinical care.

The primary study population consists of adults with documented ischemic heart disease and LDL cholesterol above the recommended target level. Eligible participants are identified using Danish nationwide health registries and randomized 1:1 to receive either an electronic information letter addressing elevated LDL cholesterol (the "LDL letter") or no letter. The LDL letter provides general, non-technical information about LDL cholesterol as a cardiovascular risk factor in ischemic heart disease and encourages recipients to consult their physician if relevant.

A secondary study population is defined as a subset of the primary population with elevated lipoprotein(a) \[Lp(a)\] levels identified from laboratory registry data. Participants in this subgroup are independently randomized 1:1 to receive or not receive an additional electronic information letter addressing elevated Lp(a) (the "Lp(a) letter"). The Lp(a) letter provides information on Lp(a) as a genetically determined and independent cardiovascular risk factor and emphasizes the importance of optimizing other modifiable risk factors. The two randomizations are conducted independently, resulting in a partially factorial design in which participants with elevated Lp(a) may receive no letter, the LDL letter only, the Lp(a) letter only, or both letters.

All intervention letters are delivered through Denmark's mandatory national digital mailbox system (Digital Post). The interventions are informational and non-invasive. The study does not involve any in-person visits, clinical procedures, or changes to usual medical care.

The primary outcome is disease-related patient activation, defined as the proportion of participants with at least one LDL cholesterol measurement recorded within 6 months after randomization. Secondary outcomes include general patient activation, assessed by the number of healthcare contacts in general practice or outpatient hospital settings, and cardiometabolic risk-factor monitoring, defined as the proportion of participants with at least one cardiometabolic blood test (lipid profile, hemoglobin A1c, or creatinine) within 6 months after randomization. Additional exploratory outcomes related to laboratory testing, healthcare utilization, medication use, and clinical events are assessed during longer-term follow-up.

All baseline characteristics, outcomes, and follow-up data are obtained from Danish nationwide health and administrative registries. Due to the registry-based and informational nature of the interventions, informed consent is not required. The primary analysis is conducted 6 months after randomization, with additional exploratory follow-up extending up to 5 years.

Вмешательства

Поведенческое 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.
Поведенческое 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.

Первичные конечные точки

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

Вторичные конечные точки (2)

Number of healthcare contacts (general practice or outpatient hospital) within 6 months following randomization [Срок оценки: 6 months after randomization]
At least one cardiometabolic blood test [Срок оценки: Within 6 months after randomization]

Критерии участия

Критерии включения

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