Digital Health Education to Improve Cardiovascular Health Across Different Socioeconomic Groups: e-DUCASS Advance (e-DUCASS Adv)
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.
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：e-DUCASS Advance Study Team
- 電話番号：+34 680 761 975
- メール：educass.advance@imibic.org
研究場所
-
-
-
Córdoba、スペイン、14004
- 募集
- Instituto Maimónides de Investigación Biomédica de Córdoba
-
コンタクト：
- e-DUCASS Advance Study Team
- 電話番号：+34 680 761 975
- メール：educass.advance@imibic.org
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
介入なし：Control group
No further intervention |
|
|
実験的：Digital Intervention Group
Participants 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. |
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.
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Mean Change From Baseline in Life's Essential 8 Score at 24 Months
時間枠：Baseline and 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. |
Baseline and 24 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Mean Change From Baseline in Life's Essential 8 Score at 12 Months
時間枠：Baseline and 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. |
Baseline and 12 months
|
|
Mean Change From Baseline in Mediterranean Lifestyle Index Score at 24 Months
時間枠：Baseline and 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. |
Baseline and 24 months
|
|
Mean Change From Baseline in Mediterranean Diet Adherence Screener Score at 24 Months
時間枠：Baseline and 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. |
Baseline and 24 months
|
|
Mean Change From Baseline in Physical Activity at 24 Months
時間枠：Baseline and 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. |
Baseline and 24 months
|
|
Mean Change From Baseline in Patient Health Questionnaire-9 Score at 24 Months
時間枠：Baseline and 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. |
Baseline and 24 months
|
|
Mean Change From Baseline in Generalized Anxiety Disorder-7 Score at 24 Months
時間枠：Baseline and 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. |
Baseline and 24 months
|
|
Mean Change From Baseline in EQ-5D-5L Index Score at 24 Months
時間枠：Baseline and 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. |
Baseline and 24 months
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Mean Change From Baseline in Life's Essential 8 Score at 24 Months by Baseline Chronotype
時間枠：Baseline and 24 months
|
Baseline chronotype will be assessed using the Morningness-Eveningness Questionnaire. The questionnaire score ranges from 16 to 86 points, with higher scores indicating a greater morning preference. Participants will be classified as having a morning, intermediate, or evening chronotype according to prespecified scoring criteria. Mean change in the Life's Essential 8 score from baseline to 24 months will be evaluated within each chronotype category to determine whether the effect of the digital intervention on cardiovascular health differs according to baseline chronotype. |
Baseline and 24 months
|
|
Association of Circadian Health Parameters With Baseline Life's Essential 8 Score and Its Change at 24 Months
時間枠：Seven-day circadian monitoring during the first months after enrollment; Life's Essential 8 assessed at baseline and 24 months
|
Circadian health will be assessed once during a seven-day monitoring period conducted within the first months after enrollment using the KronoWise KW-5 wrist-worn device. The device continuously records distal skin temperature, motor activity, wrist position, light exposure, and sleep-wake patterns. Prespecified parameters derived from these signals will be used to characterize circadian timing, amplitude, regularity, fragmentation, and sleep. These circadian health parameters will be examined in relation to the baseline Life's Essential 8 score and prospectively in relation to the change in Life's Essential 8 score from baseline to 24 months. |
Seven-day circadian monitoring during the first months after enrollment; Life's Essential 8 assessed at baseline and 24 months
|
|
Mean Change From Baseline in Life's Essential 8 Score at 24 Months by Sex
時間枠：Baseline and 24 months
|
Mean change in the Life's Essential 8 score from baseline to 24 months will be evaluated separately according to sex recorded at baseline. The overall score ranges from 0 to 100 points, with higher scores indicating better cardiovascular health. Differences in the effect of the digital intervention according to sex will be assessed using a prespecified interaction analysis. |
Baseline and 24 months
|
|
Mean Change From Baseline in Life's Essential 8 Score at 24 Months by Age Group
時間枠：Baseline and 24 months
|
Mean change in the Life's Essential 8 score from baseline to 24 months will be evaluated according to four prespecified age groups: adolescents aged 12 to 19 years, young adults aged 20 to 39 years, middle-aged adults aged 40 to 64 years, and older adults aged 65 to 79 years. These categories are based on the age ranges used in American Heart Association population analyses of Life's Essential 8. The overall score ranges from 0 to 100 points, with higher scores indicating better cardiovascular health. Differences in the effect of the digital intervention across age groups will be assessed using a prespecified interaction analysis. |
Baseline and 24 months
|
|
Mean Change From Baseline in Life's Essential 8 Diet Component Score at 12 and 24 Months
時間枠：Baseline, 12 months, and 24 months
|
The diet component of Life's Essential 8 will be scored from 0 to 100 points using the age-appropriate American Heart Association criteria. Higher scores indicate a healthier dietary pattern. For each participant, changes will be calculated as the 12-month score minus the baseline score and as the 24-month score minus the baseline score. |
Baseline, 12 months, and 24 months
|
|
Mean Change From Baseline in Life's Essential 8 Physical Activity Component Score at 12 and 24 Months
時間枠：Baseline, 12 months, and 24 months
|
The physical activity component of Life's Essential 8 will be scored from 0 to 100 points using the age-appropriate American Heart Association criteria. Higher scores indicate a more favorable level of physical activity. For each participant, changes will be calculated as the 12-month score minus the baseline score and as the 24-month score minus the baseline score. |
Baseline, 12 months, and 24 months
|
|
Mean Change From Baseline in Life's Essential 8 Nicotine Exposure Component Score at 12 and 24 Months
時間枠：Baseline, 12 months, and 24 months
|
The nicotine exposure component of Life's Essential 8 will be scored from 0 to 100 points using the age-appropriate American Heart Association criteria. Higher scores indicate lower exposure to tobacco and nicotine. For each participant, changes will be calculated as the 12-month score minus the baseline score and as the 24-month score minus the baseline score. |
Baseline, 12 months, and 24 months
|
|
Mean Change From Baseline in Life's Essential 8 Sleep Health Component Score at 12 and 24 Months
時間枠：Baseline, 12 months, and 24 months
|
The sleep health component of Life's Essential 8 will be scored from 0 to 100 points using the age-appropriate American Heart Association criteria. Higher scores indicate a more favorable sleep duration. For each participant, changes will be calculated as the 12-month score minus the baseline score and as the 24-month score minus the baseline score. |
Baseline, 12 months, and 24 months
|
|
Mean Change From Baseline in Life's Essential 8 Body Mass Index Component Score at 12 and 24 Months
時間枠：Baseline, 12 months, and 24 months
|
The body mass index component of Life's Essential 8 will be scored from 0 to 100 points using the age-appropriate American Heart Association criteria. Higher component scores indicate a more favorable body mass index category. For each participant, changes will be calculated as the 12-month score minus the baseline score and as the 24-month score minus the baseline score. |
Baseline, 12 months, and 24 months
|
|
Mean Change From Baseline in Life's Essential 8 Blood Lipids Component Score at 12 and 24 Months
時間枠：Baseline, 12 months, and 24 months
|
The blood lipids component of Life's Essential 8 will be scored from 0 to 100 points using the age-appropriate American Heart Association criteria. Higher scores indicate a more favorable blood lipid profile. For each participant, changes will be calculated as the 12-month score minus the baseline score and as the 24-month score minus the baseline score. |
Baseline, 12 months, and 24 months
|
|
Mean Change From Baseline in Life's Essential 8 Blood Glucose Component Score at 12 and 24 Months
時間枠：Baseline, 12 months, and 24 months
|
The blood glucose component of Life's Essential 8 will be scored from 0 to 100 points using the age-appropriate American Heart Association criteria. Higher scores indicate a more favorable glycemic profile. For each participant, changes will be calculated as the 12-month score minus the baseline score and as the 24-month score minus the baseline score. |
Baseline, 12 months, and 24 months
|
|
Mean Change From Baseline in Life's Essential 8 Blood Pressure Component Score at 12 and 24 Months
時間枠：Baseline, 12 months, and 24 months
|
The blood pressure component of Life's Essential 8 will be scored from 0 to 100 points using the age-appropriate American Heart Association criteria. Higher scores indicate a more favorable blood pressure profile. For each participant, changes will be calculated as the 12-month score minus the baseline score and as the 24-month score minus the baseline score. |
Baseline, 12 months, and 24 months
|
協力者と研究者
捜査官
- 主任研究者：Pablo Pérez Martínez, Professor, PhD, MD、Instituto Maimónides de Investigación Biomédica de Córdoba
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- PI24/00875
- PI24/00875 (その他の助成金/資金番号：Instituto de Salud Carlos III (ISCIII))
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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.
IPD 共有時間枠
Beginning 12 months after publication of the primary study results and remaining available for 5 years thereafter.
IPD 共有アクセス基準
Access may be granted to qualified researchers affiliated with academic or public research institutions who submit a scientifically sound proposal for non-commercial research. Requests should be submitted to the study principal investigator and will be reviewed by the study investigators. Access will require approval of the proposed analyses, compliance with applicable ethical, institutional, and data-protection requirements, and execution of a data-use agreement prohibiting participant re-identification and unauthorized onward sharing. Approved researchers will receive only the deidentified individual participant data necessary for the approved purpose, together with the available supporting documentation, through a secure controlled-access mechanism.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- ICF
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。