Clinical trial NCT06738381: Digital Secondary Prevention After Atherosclerotic Cardiovascular Disease
Official title: Individually Tailored Digital Secondary Prevention After Hospitalization for Atherosclerotic Cardiovascular Disease: a Randomized Proof-of-concept Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atheroscleroses, Coronary
Atheroscleroses, Cerebral
Atherosclerotic Ischemic Disease
Lead sponsor: Vestre Viken Hospital Trust
Sponsor class: OTHER
Collaborators: name: University of Oslo
First posted: 2024-12-17
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Attended follow-up visits in primary healthcare
timeFrame: From baseline to weeks 6-8 and 26
measure: Attended follow-up visits in specialist healthcare
timeFrame: From baseline to weeks 6-8 and 26
Secondary outcomes:
measure: Change in the SMART2 risk score
timeFrame: From baseline to weeks 26 and 52
measure: Changes in lipid profile
timeFrame: From baseline to weeks 26 and 52
measure: Changes in systolic blood pressure
timeFrame: From baseline to weeks 26 and 52
measure: Changes in HbA1c
timeFrame: From baseline to weeks 26 and 52
measure: Changes in smoking status
timeFrame: From baseline to weeks 26 and 52
Other outcomes:
Locations:
city: Drammen
country: Norway
facility: Vestre Viken Trust Drammen hospital
state: Buskerud
Study officials:
References: