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Recruiting NCT07720349

Digital Long-term Follow-up of Patients With Coronary Artery Disease

No phase Interventional Coronary Artery Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: "HeartCheck".
Who it may be relevant to
Registry conditions: Coronary Artery Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Norway
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Digital Long-term Follow-up of Patients With Coronary Artery Disease: a Randomized Controlled Trial

Overview

The need for better follow-up of AMI patients combined with recent developments in the digital area prompted the Department of Cardiology (HJE) at Oslo University Hospital (OUS) Ullevål, in collaboration with the Department of Digital Health Research (DIG) at OUS to develop a digital solution for long-term follow-up after AMI. The overall goal of the digital solution is to increase knowledge and awareness about important lifestyle measures and CV risk factors in patients who have survived an AMI, and to make it easy for the patients to monitor their own risk factors and attainment of treatment goals during long-term follow-up. Further, the HeartCheck seeks to provide guidance to ensure medication adherence. In this project, we study whether this newly developed app (HeartCheck), through education, regular reminders and easily understandable goals for secondary prevention, can improve risk factor control and drug adherence during long-term follow-up after AMI. A randomized controlled trial (RCT) is the chosen study design, being the gold standard for testing effectiveness of interventions.

Interventions

  • Device "HeartCheck"
    a digital application developed specifically for patient support during follow-up after acute myocardial infarction or PI for stable coronary artery disease

Primary outcome measures

  • Proportion of patients fulfilling 4 evidence-based goals for risk factor control [Time frame: 12 months after inclusion in the study]

Eligibility criteria

Inclusion criteria

  • >18 years of age
  • survived a recent (<30 days) AMI and/or PCI
  • access to a smartphone or tablet
  • signed written informed consent

Exclusion criteria

  • patient does not understand Norwegian
  • patient is unable to comply with the study procedures due to severe comorbidities or high age

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Norway · 2 centers
  • Sørlandet Hospital Arendal — Arendal
  • Oslo University Hospital Ullevål — Oslo

Identifiers

NCT: NCT07720349 · 25/07916

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗