Acute Myocardial InfarctionPREVEN-IAMNCT05782023
Secondary Cardiovascular Prevention Post-acute Myocardial Infarction (AMI) Through a Web-based Empowerment Program
A study testing Digital empowerment in people with Acute Myocardial Infarction, run by Centro Cardiologico Monzino at 1 site in Italy.
Trial summary
The aim of this study is to assess the efficacy of an innovative program of secondary cardiovascular prevention focused on patient empowerment. This program will be characterized by a blended interaction between healthcare workers and the patients: first, a face-to-face first encounter in-hospital for risk factors… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- Digital empowerment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteItaly
- Study dates
- 18 Oct 2022to Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- STEMI or NSTEMI
- availability of digital communication devices (smart-phone, tablet or personal computer) and internet access
Who cannot join
- active malignancies (except for skin tumors other than melanoma)
- life expectancy <5 years
- absolute clinical indication to undergo hospital rehabilitation cycles
- cognitive status undermining digital communication devices use, even after proper training
- low understanding of Italian language, either oral or written, by clinician's judgement
- patient not foreseeing to undergo cardiology follow-up at the site
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Centro Cardiologico Monzino
Milan, 20138
José P Werba, MD, +39 0258002619, pablo.werba@cardiologicomonzino.it
About this study
Official title: Supporto Alla Prevenzione Cardiovascolare Secondaria Post-IAM Attraverso un Programma di Empowerment Web-based (PREVEN-IAM)
The aim of this study is to assess the efficacy of an innovative program of secondary cardiovascular prevention focused on patient empowerment. This program will be characterized by a blended interaction between healthcare workers and the patients: first, a face-to-face first encounter in-hospital for risk factors profiling, followed by remote interactions through a digital approach. The digital intervention is targeted at promoting the adoption and retention of virtuous behavior (e.g. smoking cessation, healthy eating habits, physical exercise, regular assumption of pharmacological therapies), improving cardiovascular risk factors control. Moreover, an exploratory endpoint will be investigated: the reduction of the residual coronary risk.
Read the detailed description
The experimental intervention will consist of educational, motivational and coaching actions of patients post-AMI through a web based interaction with the prevention team. This intervention will be: 1) personalized (based on a risk factor profile obtained in-hospital) 2) agreed (planned with the patient with shared decision making), 3) multidisciplinary (physician, nutritionist, psychologist, clinical research nurse), 4) blended, composed of a minimal initial interaction face-to-face and periodical reminders (educational, motivational and supportive) for secondary prevention, through email, a reserved website and a chat box. The intervention contents, targeted at patient empowerment, will take the behavioral change models into consideration as a theoretical basis.
The participants of both groups will undergo conventional cardiology follow-up visits indicated (at 1- 3-12-36-48 months). Blood tests or any other exam other than those indicated by routine clinical practice are not required in this study. Patients with diabetes who already wear the Abbot Freestyle Libre® glucose monitoring device will be asked access to device data within two periods of two weeks, before programmed cardiology visits at 1, 3 and 12 months. At 12 months and 48 months-follow-up visits, all participants will be assessed by the Atherosclerosis Prevention Unit, and the lifestyle questionnaires administered at baseline will be repeated. The intervention group will also take a satisfaction survey at 12 months.
- Conditions
- Acute Myocardial Infarction
- Being tested
- Digital empowerment
- Keywords
- acute myocardial infarction, secondary prevention, atherosclerosis, health empowerment
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital empowermentBehavioural
The intervention will consist of a minimal interaction face-to-face before hospital discharge for risk factors profiling followed by actions for health empowerment, delivered through an ad-hoc developed web platform, which include: a) periodic delivery of email messages with links to educational, motivational and supportive materials for secondary prevention, b) access to a message box for questions and answers and c) possibility of video-calls with the preventive team.
| Study group | Role | What they receive |
|---|---|---|
| Digital empowerment | Experimental | Usual-care + preventive intervention through digital empowerment Receives: Behavioral: Digital empowerment |
| Usual care | No intervention | Usual-care (cardiologist visit at 1, 3 and 12 months after AMI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy on measurable risk factors - BMI
Measured through the changes in the BMI, measured in weight in kilograms divided by the square of height in meters (kg/m2).
Measured: 12 months
Efficacy on measurable risk factors - systolic blood pressure
Measured through the changes in the systolic blood pressure, measured in millimetres (mm) of mercury (Hg) (mmHg).
Measured: 12 months
Efficacy on measurable risk factors - diastolic blood pressure
Measured through the changes in the diastolic blood pressure, measured in millimetres (mm) of mercury (Hg) (mmHg).
Measured: 12 months
Efficacy on measurable risk factors - LDL-cholesterol levels
Measured through the changes in the LDL-cholesterol levels, measured in milligrams per deciliter (mg/dL).
Measured: 12 months
Efficacy on measurable risk factors - glycemia levels
Measured through the changes in the glycemia levels, measured in milligrams per deciliter (mg/dL).
Measured: 12 months
Efficacy on measurable risk factors - glycosylated hemoglobin in diabetic patients
Measured through the changes in the glycosylated hemoglobin in diabetic patients, measured in percentage (%) of glycosylated hemoglobin over total hemoglobin, or in millimole of glycated hemoglobin per mole of total hemoglobin (mmol/mol).
Measured: 12 months
Efficacy on measurable risk factors - expired carbon monoxide in smokers
Measured through the changes in the expired carbon monoxide (CO) in smokers, measured in parts of expired carbon monoxide per million (ppm) per hour (ppm/h), assessed through the Smokerlyzer®.
Measured: 12 months
Secondary outcomes (15)
Efficacy on lifestyle changes - physical activity
Measured through the International Physical Activity Questionnaires (IPAQ). Based on the responses, three categories are identified:
- Inactive
- No activity is reported OR
- Some activity is reported but not enough to meet categories 2 or 3.
- Minimally Active Any one of the following 3 criteria:
- ≥3 days of vigorous activity of ≥20 minutes per day OR
- ≥5 days of moderate-intensity activity or walking of ≥30 minutes per day OR
- ≥5 days of any combination of walking, moderate-intensity or vigorous intensity activities achieving ≥600 MET-min/week.
- HEPA (health enhancing physical activity) active
Anyone of the following 2 criteria:
- Vigorous-intensity activity on ≥3 days and accumulating ≥1500 METminutes/week OR
- ≥7 days of any combination of walking, moderate-intensity or vigorous intensity activities achieving a minimum of ≥3000 MET-minutes/week.
Measured: 12 months
Efficacy on lifestyle changes - adherence to a "heart-friendly" diet
Measured through the Mediterranean Diet Adherence Screener (MEDAS). The final MEDAS score can range between 0 and 14. To categorize the overall MEDAS score, a cut-off score of ≥8 points is used to denote adherence to the principles of the mediterranean diet, while MEDAS score of ≤7 points represents mediterranean diet non-adherence.
Measured: 12 months
Efficacy on lifestyle changes - smoking reduction or cessation
Measured through the number of smoked cigarettes.
Measured: 12 months
Efficacy on lifestyle changes - self-efficacy
Measured through the General Self-Efficacy Scale, GSE. It is composed of 10 items, and the total score ranges between 10 and 40, with a higher score indicating more self-efficacy.
Measured: 12 months
Efficacy on lifestyle changes - Health Locus of Control
Measured through the Multidimensional Health Locus of Control (MHLC) questionnaire. The survey has 18 items with 6 items for each of its 3 subscales: Internal, Chance and Powerful Others. Each item is scored on a 6 point, Likert-type scale.
The Internal subscale measures the strength of the belief that the respondent's health is the result of their own behaviors: higher scores indicate a more Internal Health Locus of Control, lower scores indicate a more External Health Locus of Control.
The Powerful Others subscale measures the degree to which the respondent believes health is controlled by clinicians or a higher power. The Chance subscale indicates the degree to which the respondent believes that health is out of their control. Higher scores on both the Powerful Others and Chance subscales represent a more External Health Locus of Control while lower scores on the Powerful Others and Chance subscales indicate a more Internal Health Locus of Control.
Measured: 12 months
Efficacy on cardioprotective treatment adherence
Measured through the Morisky Medication Adherence Scale (MMAS-8). The MMAS-8 range from 0 to 8, with scores of 8 reflecting high adherence, 7 or 6 reflecting medium adherence, and <6 reflecting low adherence.
Measured: 12 months
Efficacy on glucose control in diabetic patients
Measured in diabetic patients who already use the continuous monitoring device Abbott Freestyle Libre® as the variation of the following parameters, to be considered 2 weeks before and after the educational intervention:
- mean glycemia (mg/dl)
- Glucose Management Indicator (GMI) (mmol/mol or %)
- glycemic variability (measured through the glycemic variability coefficient during monitoring, %)
- Time In Range (TIR) (70-180 mg/dl)
- High Time In Range (HTR) (>180 mg/dl)
- Low Time In Range (LTR) (<70 mg/dl)
- hyperglycemia or hypoglycemia episodes ≥15 min within the area under the curve
Measured: 12 months
Long-term maintenance of controlled levels of risk factors - BMI
Measured through the changes in the BMI, measured in weight in kilograms divided by the square of height in meters (kg/m2).
Measured: 48 months
Long-term maintenance of controlled levels of risk factors - systolic blood pressure
Measured through the changes in the systolic blood pressure, measured in millimetres (mm) of mercury (Hg) (mmHg).
Measured: 48 months
Long-term maintenance of controlled levels of risk factors - diastolic blood pressure
Measured through the changes in the diastolic blood pressure, measured in millimetres (mm) of mercury (Hg) (mmHg).
Measured: 48 months
Long-term maintenance of controlled levels of risk factors - LDL cholesterol
Measured through the changes in the LDL-cholesterol levels, measured in milligrams per deciliter (mg/dL).
Measured: 48 months
Long-term maintenance of controlled levels of risk factors - glycemia levels
Measured through the changes in the glycemia levels, measured in milligrams per deciliter (mg/dL).
Measured: 48 months
Long-term maintenance of controlled levels of risk factors - glycosylated hemoglobin in diabetic patients
Measured through the changes in the glycosylated hemoglobin in diabetic patients, measured in percentage (%) of glycosylated hemoglobin over total hemoglobin, or in millimole of glycated hemoglobin per mole of total hemoglobin (mmol/mol).
Measured: 48 months
Long-term maintenance of controlled levels of risk factors - expired carbon monoxide in smokers
Measured through the changes in the expired carbon monoxide (CO) in smokers, measured in parts of expired carbon monoxide per million (ppm) per hour (ppm/h), assessed through the Smokerlyzer®.
Measured: 48 months
Efficacy on secondary prevention
Measured as the incidence of symptomatic coronary events (exploratory analysis).
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start18 Oct 2022
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial InfarctionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Cardiologico Monzino
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Italy
- Responsible party
- Principal investigator, José Pablo Werba, Centro Cardiologico Monzino
- Investigators
- José P Werba, MD, Principal investigator, Centro Cardiologico Monzino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05782023
- Sponsor's protocol ID
- CCM 1547
- Acronym
- PREVEN-IAM
- Status last verified
- Mar 2023
- First submitted
- 21 Feb 2023
- Last updated
- 23 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporto Alla Prevenzione Cardiovascolare Secondaria Post-IAM Attraverso un Programma di Empowerment Web-based (PREVEN-IAM)
- ClinicalTrials.gov ID
- NCT05782023
- Acronym / sponsor ID
- PREVEN-IAM / CCM 1547
- Conditions
- Acute Myocardial Infarction
- Keywords
- acute myocardial infarction, secondary prevention, atherosclerosis, health empowerment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Centro Cardiologico MonzinoUniversity, hospital or other
- Collaborators
- Ministry of Health, Italy
- Study start
- 18 Oct 2022 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 23 Mar 2023 (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.
The aim of this study is to assess the efficacy of an innovative program of secondary cardiovascular prevention focused on patient empowerment. This program will be characterized by a blended interaction between healthcare workers and the patients: first, a face-to-face first encounter in-hospital for risk factors profiling, followed by remote interactions through a digital approach. The digital intervention is targeted at promoting the adoption and retention of virtuous behavior (e.g. smoking cessation, healthy eating habits, physical exercise, regular assumption of pharmacological therapies), improving cardiovascular risk factors control. Moreover, an exploratory endpoint will be investigated: the reduction of the residual coronary risk.
Detailed description
The experimental intervention will consist of educational, motivational and coaching actions of patients post-AMI through a web based interaction with the prevention team. This intervention will be: 1) personalized (based on a risk factor profile obtained in-hospital) 2) agreed (planned with the patient with shared decision making), 3) multidisciplinary (physician, nutritionist, psychologist, clinical research nurse), 4) blended, composed of a minimal initial interaction face-to-face and periodical reminders (educational, motivational and supportive) for secondary prevention, through email, a reserved website and a chat box. The intervention contents, targeted at patient empowerment, will take the behavioral change models into consideration as a theoretical basis.
The participants of both groups will undergo conventional cardiology follow-up visits indicated (at 1- 3-12-36-48 months). Blood tests or any other exam other than those indicated by routine clinical practice are not required in this study. Patients with diabetes who already wear the Abbot Freestyle Libre® glucose monitoring device will be asked access to device data within two periods of two weeks, before programmed cardiology visits at 1, 3 and 12 months. At 12 months and 48 months-follow-up visits, all participants will be assessed by the Atherosclerosis Prevention Unit, and the lifestyle questionnaires administered at baseline will be repeated. The intervention group will also take a satisfaction survey at 12 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital empowerment | Experimental | Behavioral: Digital empowermentUsual-care + preventive intervention through digital empowerment |
| Usual care | No intervention | –Usual-care (cardiologist visit at 1, 3 and 12 months after AMI) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- STEMI or NSTEMI
- availability of digital communication devices (smart-phone, tablet or personal computer) and internet access
Key exclusion criteria (6 listed)
- active malignancies (except for skin tumors other than melanoma)
- life expectancy <5 years
- absolute clinical indication to undergo hospital rehabilitation cycles
- cognitive status undermining digital communication devices use, even after proper training
- low understanding of Italian language, either oral or written, by clinician's judgement
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 empowermentThe intervention will consist of a minimal interaction face-to-face before hospital discharge for risk factors profiling followed by actions for health empowerment, delivered through an ad-hoc developed web platform, which include: a) periodic delivery of email messages with links to educational, motivational and supportive materials for secondary prevention, b) access to a message box for questions and answers and c) possibility of video-calls with the preventive team. | Behavioural | Digital empowerment |
Primary outcome
Efficacy on measurable risk factors - BMI
Time frame: 12 months
Measured through the changes in the BMI, measured in weight in kilograms divided by the square of height in meters (kg/m2).
Efficacy on measurable risk factors - systolic blood pressure
Time frame: 12 months
Measured through the changes in the systolic blood pressure, measured in millimetres (mm) of mercury (Hg) (mmHg).
Efficacy on measurable risk factors - diastolic blood pressure
Time frame: 12 months
Measured through the changes in the diastolic blood pressure, measured in millimetres (mm) of mercury (Hg) (mmHg).
Efficacy on measurable risk factors - LDL-cholesterol levels
Time frame: 12 months
Measured through the changes in the LDL-cholesterol levels, measured in milligrams per deciliter (mg/dL).
Efficacy on measurable risk factors - glycemia levels
Time frame: 12 months
Measured through the changes in the glycemia levels, measured in milligrams per deciliter (mg/dL).
Efficacy on measurable risk factors - glycosylated hemoglobin in diabetic patients
Time frame: 12 months
Measured through the changes in the glycosylated hemoglobin in diabetic patients, measured in percentage (%) of glycosylated hemoglobin over total hemoglobin, or in millimole of glycated hemoglobin per mole of total hemoglobin (mmol/mol).
Efficacy on measurable risk factors - expired carbon monoxide in smokers
Time frame: 12 months
Measured through the changes in the expired carbon monoxide (CO) in smokers, measured in parts of expired carbon monoxide per million (ppm) per hour (ppm/h), assessed through the Smokerlyzer®.
15 secondary outcomes
Efficacy on lifestyle changes - physical activity
Time frame: 12 months
Efficacy on lifestyle changes - adherence to a "heart-friendly" diet
Time frame: 12 months
Efficacy on lifestyle changes - smoking reduction or cessation
Time frame: 12 months
Efficacy on lifestyle changes - self-efficacy
Time frame: 12 months
Efficacy on lifestyle changes - Health Locus of Control
Time frame: 12 months
Efficacy on cardioprotective treatment adherence
Time frame: 12 months
Efficacy on glucose control in diabetic patients
Time frame: 12 months
Long-term maintenance of controlled levels of risk factors - BMI
Time frame: 48 months
Long-term maintenance of controlled levels of risk factors - systolic blood pressure
Time frame: 48 months
Long-term maintenance of controlled levels of risk factors - diastolic blood pressure
Time frame: 48 months
Long-term maintenance of controlled levels of risk factors - LDL cholesterol
Time frame: 48 months
Long-term maintenance of controlled levels of risk factors - glycemia levels
Time frame: 48 months
Long-term maintenance of controlled levels of risk factors - glycosylated hemoglobin in diabetic patients
Time frame: 48 months
Long-term maintenance of controlled levels of risk factors - expired carbon monoxide in smokers
Time frame: 48 months
Efficacy on secondary prevention
Time frame: 48 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
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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. This study is not recruiting at the moment.
José P Werba, MD principal investigator
Centro Cardiologico Monzino
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 empowerment in people with Acute Myocardial Infarction, run by Centro Cardiologico Monzino at 1 site in Italy.
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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 23 Mar 2023. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact José P Werba, MD (+39 0258002619, pablo-werba@cardiologicomonzino.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy on measurable risk factors - BMI (time frame: 12 months). The study lists 7 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 23 Mar 2023.