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NCT Number: NCT06738381

Digital Secondary Prevention After Atherosclerotic Cardiovascular Disease

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vestre Viken Trust Drammen hospital

Drammen, Buskerud, 3014, Norway

Location status: Recruiting

Location contact

Anja Lia

CONTACT

[email protected]

+4792460856

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Digital intervention and motivational counselling

Behavioral

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

Primary outcomes

  1. Attended follow-up visits in primary healthcare

    Time frame: From baseline to weeks 6-8 and 26

    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

  2. Attended follow-up visits in specialist healthcare

    Time frame: From baseline to weeks 6-8 and 26

    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

Secondary outcomes

  1. Change in the SMART2 risk score

    Time frame: From baseline to weeks 26 and 52

    Between-group change in the validated SMART2 risk score

  2. Changes in lipid profile

    Time frame: From baseline to weeks 26 and 52

    Between-group changes in total cholesterol, HDL-cholesterol and LDL-cholesterol in blood

  3. Changes in systolic blood pressure

    Time frame: From baseline to weeks 26 and 52

    Between-group changes in systolic blood pressure

  4. Changes in HbA1c

    Time frame: From baseline to weeks 26 and 52

    Between-group change in HbA1c levels in blood

  5. Changes in smoking status

    Time frame: From baseline to weeks 26 and 52

    Between-group differences in the proportion who report smoking abstinence

Study contacts

Contact information is provided by the study sponsor or research team.

John Munkhaugen, MD, PhD

CONTACT

[email protected]

+4797524194

Sponsors and collaborators

Lead sponsor

Vestre Viken Hospital Trust

Other

Collaborators

  • University of Oslo

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 17, 2024
Registry last updated
Feb 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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