Digital Secondary Prevention After Atherosclerotic Cardiovascular Disease

NCT06738381 | Recruiting

• 1 other identifier: 807276
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atheroscleroses, Coronary; Atheroscleroses, Cerebral; Atherosclerotic Ischemic Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Change in the SMART2 risk score

  From baseline to weeks 26 and 52

• Changes in lipid profile

  From baseline to weeks 26 and 52

• Changes in systolic blood pressure

  From baseline to weeks 26 and 52

• Changes in HbA1c

  From baseline to weeks 26 and 52

• Changes in smoking status

  From baseline to weeks 26 and 52

Study Arms (2)

Digital intervention and motivational counselling

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Interventions

Digital intervention and motivational counselling BEHAVIORAL

A single sesstion of motivational interviewing and access to a digital plattform for a six months period

Control group; Digital intervention and motivational counselling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vestre Viken Hospital Trust: lead
• University of Oslo: collaborator

Study Sites (1)

Vestre Viken Trust Drammen hospital

Drammen, Buskerud, 3014, Norway

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Intracranial Arteriosclerosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

John Munkhaugen, MD, PhD

CONTACT

+4797524194; johmun@vestreviken.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: December 17, 2024
• Study Start: February 3, 2025
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): December 20, 2026
• Last Updated: February 21, 2025

Record last verified: 2025-02

Locations

NO (1)