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Cardiovascular Healthe-DUCASS AdvNCT07835386

Digital Health Education to Improve Cardiovascular Health Across Different Socioeconomic Groups: e-DUCASS Advance

A study testing Enhanced Digital Health Literacy Program in people with Cardiovascular Health and Health Literacy, run by Maimónides Biomedical Research Institute of Córdoba at 1 site in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The e-DUCASS Advance study is a randomized study evaluating whether a 24-month digital health education program can improve cardiovascular health among people living in Córdoba, Spain, and representing different socioeconomic backgrounds and areas of the city. Read more about this study

Who is it for?
Ages 12 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Cardiovascular Health, Health Literacy
What is being tested?
Enhanced Digital Health Literacy Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
1 siteSpain
Study dates
1 Nov 2025to 15 Dec 2028
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 12 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Age 12 to 79 years.
  • Provision of written informed consent. For participants younger than 18 years, written informed consent from a parent or legal guardian and assent from the participant, when appropriate, are required.
  • Both healthy individuals and individuals with stable medical conditions are eligible. No specific disease or cardiovascular risk factor is required for participation.

Who cannot join

  • Life expectancy of less than 5 years.
  • Inability to complete the study intervention or scheduled study procedures, either independently or, when applicable, with support from a parent, legal guardian, or household member.
  • Serious or unstable medical conditions that could limit participation, follow-up, or survival, including hypertension or diabetes with target-organ damage affecting survival, disabling clinical manifestations of cerebrovascular disease, severe psychiatric illness, advanced chronic kidney disease, chronic liver disease, cancer under active treatment, severe or very severe chronic obstructive pulmonary disease, endocrine disease at risk of decompensation, or clinically significant chronic gastrointestinal disease.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

e-DUCASS Advance Study Team contact

+34 680 761 975

educass.advance@imibic.org

Spain1 site, 1 recruiting
  • Instituto Maimónides de Investigación Biomédica de Córdoba

    Córdoba, 14004

    e-DUCASS Advance Study Team, +34 680 761 975, educass.advance@imibic.org

    Recruiting

Other trials in Spain

About this study

Official title: Educational Strategy in Populations of Different Socioeconomic Status to Improve Cardiovascular Health Through a Digital Health Literacy Program: e-DUCASS Advance

The e-DUCASS Advance study is a randomized study evaluating whether a 24-month digital health education program can improve cardiovascular health among people living in Córdoba, Spain, and representing different socioeconomic backgrounds and areas of the city. Approximately 600 participants aged 12 to 79 years will be enrolled. Participants will be assigned by family so that members of the same family remain in the same study group.

All participants will first receive an initial basic health education workshop covering healthy eating, physical activity, sleep, tobacco use, and other health-related behaviors. Families will then be randomly assigned to one of two groups. The control group will receive no additional educational intervention, whereas the digital intervention group will receive weekly educational content through a web-based application or messaging channels. This content will include short videos, infographics, knowledge assessments, motivational activities, and access to support.

Read more

Cardiovascular health will be assessed at baseline, 12 months, and 24 months using the American Heart Association's Life's Essential 8 score. This score evaluates diet, physical activity, nicotine exposure, sleep, body mass index, blood lipids, blood glucose, and blood pressure.

The study will compare changes in cardiovascular health between the two groups and examine whether the effect of the program differs according to the socioeconomic characteristics of the participants' areas of residence. Other assessments will include adherence to a Mediterranean lifestyle, health and nutrition literacy, physical activity and sedentary behavior, chronotype, quality of life, anxiety, and depression.

Read the detailed description

e-DUCASS Advance is a 24-month, parallel-group, cluster-randomized controlled trial designed to evaluate the effectiveness of an enhanced digital health literacy intervention for improving cardiovascular health among people with different socioeconomic backgrounds in Córdoba, Spain. Participants are recruited from across the city.

The household is the unit of randomization, ensuring that all participating members of the same household are assigned to the same trial arm and reducing the risk of contamination between groups. Households are randomized in a 1:1 ratio to the control or digital intervention group using stratified permuted block randomization.

Randomization is stratified by socioeconomic status and household composition, resulting in six strata. Household composition is classified into three categories: households with children, households comprising two or more adults without children, and single-person households. Socioeconomic status is categorized as high or low-middle. Households within the upper income quintile of the municipal distribution for Córdoba, based on the 2023 Household Income Distribution Atlas of the Spanish National Statistics Institute, are classified as high income. All remaining households are classified within the low-middle-income category.

The randomization sequence was generated by an independent statistical programmer using the blockrand package, version 1.5, in R statistical software, version 4.4.2. Allocation was centralized, and researchers responsible for participant recruitment were unaware of the block sizes and upcoming assignments. Randomization was implemented in three successive waves as recruitment progressed, following a prespecified master randomization log.

After the baseline clinical and sociodemographic assessment, all participants receive an initial basic health education workshop addressing healthy eating, physical activity, sleep, tobacco use, and other cardiovascular health-related behaviors. Participants assigned to the control group receive no further structured educational intervention. Participants assigned to the digital intervention group receive weekly educational content through a web-based application or messaging channels for 24 months.

The digital intervention is based on three components: education, evaluation, and motivation. Educational materials include short videos and infographics with practical and accessible messages about cardiovascular health and healthy lifestyles. Brief assessments are used to reinforce knowledge and monitor engagement. Motivational activities, participation feedback, and access to support are intended to encourage sustained interaction with the program and the adoption of healthier behaviors.

Participants undergo study assessments at baseline, 12 months, and 24 months. These assessments include clinical history, anthropometric measurements, blood pressure, body composition, and biochemical measurements. Cardiovascular health is evaluated using the American Heart Association's Life's Essential 8 score, ranging from 0 to 100 and comprising diet, physical activity, nicotine exposure, sleep health, body mass index, blood lipids, blood glucose, and blood pressure.

The primary objective is to compare changes in Life's Essential 8 between the digital intervention and control groups and to examine whether the effect of the intervention differs according to household socioeconomic status. Secondary objectives include evaluating changes in adherence to a Mediterranean lifestyle, health and nutrition literacy, dietary habits, physical activity and sedentary behavior, chronotype, quality of life, anxiety, and depression. Potential differences according to age and sex will also be explored.

The target enrollment is approximately 600 participants aged 12 to 79 years. The sample size calculation accounts for household-level clustering and expected losses to follow-up. Longitudinal analyses will account for repeated measurements and the clustering of participants within households.

Being tested
Enhanced Digital Health Literacy Program
Keywords
Life's Essential 8, Digital Health education, Cardiovascular disease prevention, Lifestyle intervention, Health equity, Social determinants of health

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Enhanced Digital Health Literacy ProgramBehavioural

    Also called e-DUCASS Advance Digital Intervention

    The intervention is a 24-month enhanced digital health literacy program designed to improve cardiovascular health through sustained education on healthy lifestyles. Participants receive new educational content weekly through a web-based application. Content includes short videos and summary infographics addressing healthy eating, physical activity, sleep health, avoidance of tobacco and nicotine exposure, and other cardiovascular health-related behaviors. The program combines education, evaluation, and motivation. Brief knowledge assessments reinforce learning, while information on content access and views is used to monitor engagement. Motivational activities, participation feedback, and access to support are provided to encourage adherence and sustained behavior change. Content is adapted when appropriate for adolescent participants.

Study groups in NCT07835386
Study groupRoleWhat they receive
Control groupNo interventionNo further intervention
Digital Intervention GroupExperimentalParticipants receive the initial basic health education workshop provided to all study participants, followed by a 24-month enhanced digital health literacy intervention. Weekly educational content is delivered through a web-based application or messaging channels and includes short videos, infographics, brief knowledge assessments, motivational activities, participation feedback, and access to support. The content addresses healthy eating, physical activity, sleep, tobacco use, and other health-related behaviors aimed at improving cardiovascular health.
Receives: Behavioral: Enhanced Digital Health Literacy Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Change From Baseline in Life's Essential 8 Score at 24 Months

    Cardiovascular health will be assessed using the American Heart Association's Life's Essential 8 score. The overall score is calculated as the mean of eight component scores: diet, physical activity, nicotine exposure, sleep health, body mass index, blood lipids, blood glucose, and blood pressure. Each component and the overall score range from 0 to 100 points, with higher scores indicating better cardiovascular health.

    Measured: Baseline and 24 months

Secondary outcomes (7)
  1. Mean Change From Baseline in Life's Essential 8 Score at 12 Months

    Cardiovascular health will be assessed using the American Heart Association's Life's Essential 8 score. The overall score is calculated as the mean of eight component scores: diet, physical activity, nicotine exposure, sleep health, body mass index, blood lipids, blood glucose, and blood pressure. Each component and the overall score range from 0 to 100 points, with higher scores indicating better cardiovascular health.

    Measured: Baseline and 12 months

  2. Mean Change From Baseline in Mediterranean Lifestyle Index Score at 24 Months

    Adherence to the Mediterranean lifestyle will be assessed using the 28-item Mediterranean Lifestyle Index (MEDLIFE), which evaluates Mediterranean food consumption, Mediterranean dietary habits, physical activity, rest, and social interaction. Each item is scored as 0 or 1, producing an overall score ranging from 0 to 28 points. Higher scores indicate greater adherence to a Mediterranean lifestyle.

    Measured: Baseline and 24 months

  3. Mean Change From Baseline in Mediterranean Diet Adherence Screener Score at 24 Months

    Adherence to the Mediterranean diet will be assessed using the 14-item Mediterranean Diet Adherence Screener (MEDAS). Each item contributes 0 or 1 point, resulting in a total score ranging from 0 to 14 points. Higher scores indicate greater adherence to the Mediterranean dietary pattern.

    Measured: Baseline and 24 months

  4. Mean Change From Baseline in Physical Activity at 24 Months

    Physical activity will be assessed using the International Physical Activity Questionnaire (IPAQ), a validated self-reported instrument evaluating physical activity performed during the previous seven days. A physical activity score will be derived according to the standardized IPAQ scoring procedure, with higher values indicating a greater level of physical activity.

    Measured: Baseline and 24 months

  5. Mean Change From Baseline in Patient Health Questionnaire-9 Score at 24 Months

    Depressive symptoms will be assessed using the 9-item Patient Health Questionnaire (PHQ-9). Each item is scored from 0 to 3, producing a total score ranging from 0 to 27 points. Higher scores indicate greater severity of depressive symptoms. For each participant, change will be calculated as the 24-month score minus the baseline score.

    Measured: Baseline and 24 months

  6. Mean Change From Baseline in Generalized Anxiety Disorder-7 Score at 24 Months

    Anxiety symptoms will be assessed using the 7-item Generalized Anxiety Disorder scale (GAD-7). Each item is scored from 0 to 3, producing a total score ranging from 0 to 21 points. Higher scores indicate greater severity of anxiety symptoms. For each participant, change will be calculated as the 24-month score minus the baseline score.

    Measured: Baseline and 24 months

  7. Mean Change From Baseline in EQ-5D-5L Index Score at 24 Months

    Health-related quality of life will be assessed using the EQ-5D-5L questionnaire, which evaluates mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Each dimension has five levels of severity. Responses will be converted into a health utility index using the Spanish EQ-5D-5L value set. The index has a maximum value of 1, representing full health, and may include values below 0 for health states considered worse than death. Higher values indicate better health-related quality of life. Change will be calculated as the 24-month index value minus the baseline value.

    Measured: Baseline and 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2026
  2. Study start1 Nov 2025
  3. Primary completion15 Dec 2028 (estimated)
  4. Study completion15 Dec 2028 (estimated)

Resources

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
Model description
Two-arm, parallel, cluster-randomized design. Households are randomized in a 1:1 ratio to the digital intervention or control group, with all participating members of the same household assigned to the same study arm. Randomization is stratified by household composition and socioeconomic status. Recruitment is conducted in three successive waves, but participants remain in their assigned study arm throughout the 24-month follow-up, with no crossover between groups.
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07835386
Sponsor's protocol ID
PI24/00875
Other IDs
PI24/00875
Acronym
e-DUCASS Adv
Status last verified
Sep 2026
First submitted
17 Sep 2026
Last updated
22 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Deidentified individual participant data underlying the results reported in study publications may be shared with qualified researchers from academic institutions for scientifically sound, non-commercial research. Access will be subject to approval by the study principal investigators and compliance with applicable ethical, institutional, and data-protection requirements. Data will be provided through a secure, controlled-access mechanism and may require an approved research proposal and a data-use agreement. No directly identifying participant information will be shared.

Questions about this trial

What is this clinical trial studying?

A study testing Enhanced Digital Health Literacy Program in people with Cardiovascular Health and Health Literacy, run by Maimónides Biomedical Research Institute of Córdoba at 1 site in Spain.

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 3 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 22 Sep 2026. 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 Spain. 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 e-DUCASS Advance Study Team (+34 680 761 975, educass.advance@imibic.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change From Baseline in Life's Essential 8 Score at 24 Months (time frame: Baseline and 24 months). 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 22 Sep 2026.

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