Digital Secondary Prevention After Atherosclerotic Cardiovascular Disease

Официальное название

Individually Tailored Digital Secondary Prevention After Hospitalization for Atherosclerotic Cardiovascular Disease: a Randomized Proof-of-concept Study

Обзор

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.

Вмешательства

• Поведенческое Digital intervention and motivational counselling
  A single sesstion of motivational interviewing and access to a digital plattform for a six months period

Первичные конечные точки

• Attended follow-up visits in primary healthcare [Срок оценки: From baseline to weeks 6-8 and 26]
• Attended follow-up visits in specialist healthcare [Срок оценки: From baseline to weeks 6-8 and 26]

Вторичные конечные точки (5)

• Change in the SMART2 risk score [Срок оценки: From baseline to weeks 26 and 52]
• Changes in lipid profile [Срок оценки: From baseline to weeks 26 and 52]
• Changes in systolic blood pressure [Срок оценки: From baseline to weeks 26 and 52]
• Changes in HbA1c [Срок оценки: From baseline to weeks 26 and 52]
• Changes in smoking status [Срок оценки: From baseline to weeks 26 and 52]

Критерии участия

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Норвегия · 1 центр

• Vestre Viken Trust Drammen hospital — Drammen

Идентификаторы

NCT: NCT06738381 · 807276

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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