Atheroscleroses, Cerebral, Atheroscleroses, Coronary, Atherosclerotic Ischemic Disease
Conditions
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.
Interventions
BEHAVIORALDigital intervention and motivational counselling
A single sesstion of motivational interviewing and access to a digital plattform for a six months period
Sponsors
University of Oslo
Vestre Viken Hospital Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Attended follow-up visits in specialist healthcare | 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 |
| Attended follow-up visits in primary healthcare | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in systolic blood pressure | From baseline to weeks 26 and 52 | Between-group changes in systolic blood pressure |
| Change in the SMART2 risk score | From baseline to weeks 26 and 52 | Between-group change in the validated SMART2 risk score |
| Changes in smoking status | From baseline to weeks 26 and 52 | Between-group differences in the proportion who report smoking abstinence |
| Changes in HbA1c | From baseline to weeks 26 and 52 | Between-group change in HbA1c levels in blood |
| Changes in lipid profile | From baseline to weeks 26 and 52 | Between-group changes in total cholesterol, HDL-cholesterol and LDL-cholesterol in blood |
Countries
Norway
Contacts
Primary ContactJohn Munkhaugen, MD, PhD
Outcome results
None listed