Digital Secondary Prevention After Atherosclerotic Cardiovascular Disease

Individually Tailored Digital Secondary Prevention After Hospitalization for Atherosclerotic Cardiovascular Disease: a Randomized Proof-of-concept Study

Atherosclerotic cardiovascular disease (ASCVD) remains a leading cause of morbidity and mortality worldwide and in Norway. Approximately 50% of the patients admitted to hospitals with an acute ASCVD event has had a previous event. The high number of patients being readmitted to hospitals with new ASCVD events is to a large degree explained by poor control of established risk factors such as high LDL-cholesterol, high blood pressure (BP), diabetes, obesity, smoking, and lack of physical activity, as well as poor adherence to evidence-based medication. This pragmatic, open-label proof-of-concept study conducted at three secondary care hospitals will randomly assign patients hospitalized with an ASCVD event to either: (i) brief advice, tailored discharge information to general practitioners, and a nurse-led outpatient visit (control), or (ii) the same interventions as (i) plus a single in-hospital motivational counselling session and access to a digital platform for a 6 months period with patient information/videos and an individualized treatment plan and follow-up plan. The primary end point will be between-group differences in the proportion who report having attended follow-up visits in primary (primary care physicians and community-based healthy life centres) and specialist (cardiac rehabilitation programs, hospital outpatient visits) healthcare after 8 weeks and 6 months follow-up. Secondary end points will be change in the SMART2 risk score and cardiovascular risk factors between baseline and 6 and 12 months follow-up. Exploratory end points will be changes in adherence to cardiovascular drugs, self-care behaviour, health literacy, patient activation, and quality of life.

Study Overview

• Status: Recruiting
• Conditions: Atherosclerotic Ischemic Disease; Atheroscleroses, Coronary; Atheroscleroses, Cerebral
• Intervention / Treatment: Behavioral: Digital intervention and motivational counselling

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: John Munkhaugen, MD, PhD; Phone Number: +4797524194; Email: johmun@vestreviken.no

Study Locations

• Norway
  • Buskerud
    • Drammen, Buskerud, Norway, 3014
      • Recruiting
      • Vestre Viken Trust Drammen hospital
      • Contact: Anja Lia; Phone Number: +4792460856; Email: anjlia@vestreviken.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion criteria (all the following):

• Aged >=18 years and signed informed consent and expected cooperation according to ICH/GCP and national/local regulations
• Hospitalised with an planned or unplanned ASCVD event and/or established atherosclerosis
• Access to a smartphone or tablet

Exclusion criteria (any of the following):

-Any condition or situation, that in the investigator's opinion could put the subject at significant risk, confound the study results, interfere significantly with the subject participation in the study, or rendering informed consent unfeasible not limited to: cognitive impairment, seizure disorders, active suicidal intent or plans, substance or alcohol dependence, psychotic disease, major depressive disorders or bipolar disorders, receiving concurrent psychological treatments, and ongoing night shift work.

• Short life expectancy (<12 months) due to end-organ (i.e COPD 4, CKD 4/5) or malignant diseases
• Clinically significant symptoms of anxiety and depression (HADS A and/or HADS-D score ≥8)
• Not being able to understand Norwegian.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Digital intervention and motivational counselling; A single in-hospital motivational counselling session and access to a digital platform for a 6 months period with patient information, videos and an individualized treatment plan and follow-up plan.	Behavioral: Digital intervention and motivational counselling; A single sesstion of motivational interviewing and access to a digital plattform for a six months period
Active Comparator: Control group; Brief advices, tailored discharge information to patients and their general practitioners, and a nurse-led outpatient visit at six months follow-up	Behavioral: Digital intervention and motivational counselling; A single sesstion of motivational interviewing and access to a digital plattform for a six months period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attended follow-up visits in primary healthcare	Between-group differences in the proportion attending follow-up visits at primary care physicians and community-based healthy life centres assessed by patient self-report and from medical records	From baseline to weeks 6-8 and 26
Attended follow-up visits in specialist healthcare	Between-group differences in the proportion attending follow-up visits at cardiac rehabilitation programs and at hospital outpatient visits assessed by patient self-report and from hospital medical records	From baseline to weeks 6-8 and 26

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the SMART2 risk score	Between-group change in the validated SMART2 risk score	From baseline to weeks 26 and 52
Changes in lipid profile	Between-group changes in total cholesterol, HDL-cholesterol and LDL-cholesterol in blood	From baseline to weeks 26 and 52
Changes in systolic blood pressure	Between-group changes in systolic blood pressure	From baseline to weeks 26 and 52
Changes in HbA1c	Between-group change in HbA1c levels in blood	From baseline to weeks 26 and 52
Changes in smoking status	Between-group differences in the proportion who report smoking abstinence	From baseline to weeks 26 and 52

Collaborators and Investigators

• Sponsor: Vestre Viken Hospital Trust
• Collaborators: University of Oslo

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2025
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): December 20, 2026

Study Registration Dates

• First Submitted: December 12, 2024
• First Submitted That Met QC Criteria: December 12, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 19, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Intracranial Arterial Diseases; Cardiovascular Diseases; Coronary Artery Disease; Myocardial Ischemia; Intracranial Arteriosclerosis; Atherosclerosis
• Other Study ID Numbers: 807276

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No