An interventional study of Digital intervention and motivational counselling in Atheroscleroses, Coronary, Atheroscleroses, Cerebral and Atherosclerotic Ischemic Disease, sponsored by Vestre Viken Hospital Trust. Recruiting at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-21.
Sponsored by Vestre Viken Hospital Trust · Not applicable, Interventional, and Treatment
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.
93 studies on the registry are indexed under Intracranial Arteriosclerosis; 41 are open to participants now.
This study's planned enrollment of 300 is above the median of 194 across 55 interventional studies indexed under Intracranial Arteriosclerosis.
Browse Intracranial Arteriosclerosis studies →Vestre Viken Hospital Trust is the lead sponsor of 51 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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
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
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
Time frame: 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
Time frame: From baseline to weeks 6-8 and 26
Change in the SMART2 risk score
Between-group change in the validated SMART2 risk score
Time frame: From baseline to weeks 26 and 52
Changes in lipid profile
Between-group changes in total cholesterol, HDL-cholesterol and LDL-cholesterol in blood
Time frame: From baseline to weeks 26 and 52
Changes in systolic blood pressure
Between-group changes in systolic blood pressure
Time frame: From baseline to weeks 26 and 52
Changes in HbA1c
Between-group change in HbA1c levels in blood
Time frame: From baseline to weeks 26 and 52
Changes in smoking status
Between-group differences in the proportion who report smoking abstinence
Time frame: From baseline to weeks 26 and 52
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Vestre Viken Hospital Trust