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| Name | Class |
|---|---|
| University of Oslo | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital intervention and motivational counselling | Behavioral | A single sesstion of motivational interviewing and access to a digital plattform for a six months period |
|
| 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 |
| 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 |
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Inclusion criteria (all the following):
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| John Munkhaugen, MD, PhD | Contact | +4797524194 | johmun@vestreviken.no |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vestre Viken Trust Drammen hospital | Recruiting | Drammen | Buskerud | 3014 | Norway |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D002537 | Intracranial Arteriosclerosis |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 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 |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |