Digital Long-term Follow-up of Patients With Coronary Artery Disease: a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 630
- Locations
- 2
- Primary Endpoint
- The proportion of patients fulfilling all of the following evidence-based goals for risk factor control at 1 year follow-up: 1) BP< 130/80 mmHg, 2) LDL-cholesterol <1.4 mmol/l, 3) HbA1c<53 mmol/mol, and 4) No smoking.
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Usual care
Patients are offered standard followed up by their hospital and GP
Use of a digital application for follow-up
Use of the application "Heart-Check" developed by the researchers
Intervention: "HeartCheck" (Device)
Outcomes
Primary Outcomes
The proportion of patients fulfilling all of the following evidence-based goals for risk factor control at 1 year follow-up: 1) BP< 130/80 mmHg, 2) LDL-cholesterol <1.4 mmol/l, 3) HbA1c<53 mmol/mol, and 4) No smoking.
Time Frame: 12 months after inclusion in the study
Proportion of patients fulfilling 4 evidence-based goals for risk factor control
Time Frame: 12 months after inclusion in the study
Proportion of patients who fulfills all of the following: 1) BP \<130/80 mmHg, 2) LDL-cholesterol \<1.4 mmol/l, 3) HbA1c \<53mmol/mol, 4) No smoking
Secondary Outcomes
No secondary outcomes reported
Investigators
Sigrun Halvorsen
Professor
Oslo University Hospital