Digital Secondary Prevention After Atherosclerotic Cardiovascular Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Digital intervention and motivational counselling.
- Who it may be relevant to
- Registry conditions: Atheroscleroses, Coronary, Atheroscleroses, Cerebral, Atherosclerotic Ischemic Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Norway
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Individually Tailored Digital Secondary Prevention After Hospitalization for Atherosclerotic Cardiovascular Disease: a Randomized Proof-of-concept Study
Overview
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
- Behavioral Digital intervention and motivational counselling
A single sesstion of motivational interviewing and access to a digital plattform for a six months period
Primary outcome measures
- Attended follow-up visits in primary healthcare [Time frame: From baseline to weeks 6-8 and 26]
- Attended follow-up visits in specialist healthcare [Time frame: From baseline to weeks 6-8 and 26]
Secondary outcome measures (5)
- Change in the SMART2 risk score [Time frame: From baseline to weeks 26 and 52]
- Changes in lipid profile [Time frame: From baseline to weeks 26 and 52]
- Changes in systolic blood pressure [Time frame: From baseline to weeks 26 and 52]
- Changes in HbA1c [Time frame: From baseline to weeks 26 and 52]
- Changes in smoking status [Time frame: From baseline to weeks 26 and 52]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Norway · 1 center
- Vestre Viken Trust Drammen hospital — Drammen
Identifiers
NCT: NCT06738381 · 807276