Atheroscleroses, CoronaryNCT06738381
Digital Secondary Prevention After Atherosclerotic Cardiovascular Disease
A study testing Digital intervention and motivational counselling in people with Atheroscleroses, Coronary and Atheroscleroses, Cerebral, run by Vestre Viken Hospital Trust at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atheroscleroses, Coronary, Atheroscleroses, Cerebral, Atherosclerotic Ischemic Disease
- What is being tested?
- Digital intervention and motivational counselling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteNorway
- Study dates
- 3 Feb 2025to 20 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- -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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Vestre Viken Trust Drammen hospital
Drammen, Buskerud, 3014
Anja Lia, +4792460856, anjlia@vestreviken.no
About this study
Official title: Individually Tailored Digital Secondary Prevention After Hospitalization for Atherosclerotic Cardiovascular Disease: a Randomized Proof-of-concept Study
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.
- Being tested
- Digital intervention and motivational counselling
- Medical subject headings
- Coronary Artery Disease, Intracranial Arteriosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital intervention and motivational counsellingBehavioural
A single sesstion of motivational interviewing and access to a digital plattform for a six months period
| Study group | Role | What they receive |
|---|---|---|
| Digital intervention and motivational counselling | Experimental | 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. Receives: Behavioral: Digital intervention and motivational counselling |
| Control group | Active comparator | Brief advices, tailored discharge information to patients and their general practitioners, and a nurse-led outpatient visit at six months follow-up Receives: Behavioral: Digital intervention and motivational counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attended follow-up visits in primary healthcare
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
Measured: From baseline to weeks 6-8 and 26
Attended follow-up visits in specialist healthcare
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
Measured: From baseline to weeks 6-8 and 26
Secondary outcomes (5)
Change in the SMART2 risk score
Between-group change in the validated SMART2 risk score
Measured: From baseline to weeks 26 and 52
Changes in lipid profile
Between-group changes in total cholesterol, HDL-cholesterol and LDL-cholesterol in blood
Measured: From baseline to weeks 26 and 52
Changes in systolic blood pressure
Between-group changes in systolic blood pressure
Measured: From baseline to weeks 26 and 52
Changes in HbA1c
Between-group change in HbA1c levels in blood
Measured: From baseline to weeks 26 and 52
Changes in smoking status
Between-group differences in the proportion who report smoking abstinence
Measured: From baseline to weeks 26 and 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start3 Feb 2025
- Primary completion20 Dec 2026 (estimated)
- Study completion20 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atheroscleroses, CoronaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vestre Viken Hospital Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06738381
- Sponsor's protocol ID
- 807276
- Status last verified
- Feb 2025
- First submitted
- 12 Dec 2024
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individually Tailored Digital Secondary Prevention After Hospitalization for Atherosclerotic Cardiovascular Disease: a Randomized Proof-of-concept Study
- ClinicalTrials.gov ID
- NCT06738381
- Acronym / sponsor ID
- 807276
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Vestre Viken Hospital TrustUniversity, hospital or other
- Collaborators
- University of Oslo
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- 20 Dec 2026 (estimated)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 17 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital intervention and motivational counselling | Experimental | Behavioral: Digital intervention and motivational counsellingA 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. |
| Control group | Active comparator | Behavioral: Digital intervention and motivational counsellingBrief advices, tailored discharge information to patients and their general practitioners, and a nurse-led outpatient visit at six months follow-up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- -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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital intervention and motivational counsellingA single sesstion of motivational interviewing and access to a digital plattform for a six months period | Behavioural | Control group, Digital intervention and motivational counselling |
Primary outcome
Attended follow-up visits in primary healthcare
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
Attended follow-up visits in specialist healthcare
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
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital intervention and motivational counselling in people with Atheroscleroses, Coronary and Atheroscleroses, Cerebral, run by Vestre Viken Hospital Trust at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact John Munkhaugen, MD, PhD (+4797524194, johmun@vestreviken.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attended follow-up visits in primary healthcare (time frame: From baseline to weeks 6-8 and 26). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2025.