Vestre Viken Trust Drammen hospital
Drammen, Buskerud, 3014, Norway
Location status: Recruiting
NCT Number: NCT06738381
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Drammen, Buskerud, 3014, Norway
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
A single sesstion of motivational interviewing and access to a digital plattform for a six months period
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
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
Time frame: From baseline to weeks 26 and 52
Between-group change in the validated SMART2 risk score
Time frame: From baseline to weeks 26 and 52
Between-group changes in total cholesterol, HDL-cholesterol and LDL-cholesterol in blood
Time frame: From baseline to weeks 26 and 52
Between-group changes in systolic blood pressure
Time frame: From baseline to weeks 26 and 52
Between-group change in HbA1c levels in blood
Time frame: From baseline to weeks 26 and 52
Between-group differences in the proportion who report smoking abstinence
Contact information is provided by the study sponsor or research team.
Vestre Viken Hospital Trust
Other
Individually Tailored Digital Secondary Prevention After Hospitalization for Atherosclerotic Cardiovascular Disease: a Randomized Proof-of-concept Study
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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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