This study is testing a training program for people from the Bangladeshi community of Ancona in the Marche Region (Italy) who have type 2 diabetes. Many people in this group find it hard to understand health information, including how to use digital health tools. This is called low health literacy. Low health literacy can make it harder to manage diabetes well. The goal of this study is to find out if the training program improves health literacy and confidence in managing diabetes. About 50 adults with type 2 diabetes from the Bangladeshi community are taking part. They are followed by the diabetes clinic at the University Hospital of the Marche Region in Ancona. Before training started, patients, caregivers, and health workers helped design the program together. This made sure the training fit the community's needs and culture. Participants complete a training program with four short modules. The modules cover diabetes, health literacy, and digital skills for managing diabetes. Researchers measure health literacy, digital skills, and confidence in managing diabetes before training, right after training, and again after 1 month and 6 months. This shows whether the improvements last over time. This study is part of JACARDI, a European project working to reduce diabetes and heart disease across Europe.
This is a monocentric pilot study conducted within the JACARDI (Joint Action on CARdiovascular diseases and Diabetes) framework, Grant Agreement ID 101126953, whose general objective is to reduce the burden of cardiovascular disease and diabetes across EU countries by integrating validated best practices through transnational pilot initiatives. The study is led by the Regional Health Agency of the Marche Region (Italy), in collaboration with the diabetes center (Centro Antidiabetico, CAD) of the University Hospital of the Marche Region (Azienda Ospedaliero-Universitaria delle Marche) in Ancona. Type 2 diabetes mellitus (DM) is a growing global health burden, and glycaemic control is a central therapeutic goal that depends heavily on patients' self-management abilities. Self-management capacity, in turn, is strongly related to individual health literacy (HL) - the ability to obtain, process, and understand basic health information - and eHealth literacy (e-HL), the ability to find, evaluate, and apply electronic health information to health problems. People with low HL and e-HL tend to have poorer health outcomes, higher hospitalization and mortality rates, and reduced ability to self-manage chronic conditions. These risks are amplified in ethnic minority populations facing linguistic and social barriers. The Bangladeshi community is one of the largest foreign populations in the Marche Region and, as part of the Asian population, is at elevated risk of type 2 DM as well as low HL and e-HL. Evidence indicates that structured, culturally oriented educational programs, delivered by trained healthcare professionals and involving peer support, are effective in improving self-management and glycaemic control, and that early, sustained involvement of stakeholders in intervention design improves implementation outcomes and long-term sustainability. The study follows the OPHELIA (OPtimising HEalth Literacy and Access) methodology, which combines local community engagement with international evidence to co-design, develop, and implement health literacy interventions that are accessible, culturally appropriate, and sustainable. The study is structured in two main phases: a pre-study (co-design) phase and a core intervention phase. The pre-study phase involves a situation analysis conducted using the Consolidated Framework for Implementation Research (CFIR) and PESTEL (Political, Economic, Social, Technological, Environmental, Legal) tools to identify enablers of and barriers to implementation, through one online and one in-person stakeholder meeting; and two focus groups with patients and their family/community members supported by a cultural mediator, to assess healthcare service accessibility, evaluate the appropriateness of the planned training content, and gather input on perceived barriers and enablers to using digital health tools. These focus groups used co-design techniques and were analyzed qualitatively. Educational materials - brochures and digital tools including videos - were developed drawing on the ACCESS training program, materials used in clinical routine, and validated guidelines from the Ministry of Health and diabetes scientific societies, then translated and culturally adapted into Italian and Bengali and made available to participants. Approximately 50 participants are organized into 4 training sessions of 10 participants each. Each session comprises 4 modules delivered in person at the CAD of Ancona, combining didactic and interactive methods, with support from a cultural mediator and diabetic peers: Module I: Awareness of DM type II, and core principles of HL and e-HL Module II: Digital health skills, part I - use of health apps and digital tools Module III: Digital health skills, part II - usability of technological devices and online health services Module IV: Self-evaluation of acquired knowledge and skills, and assessment of program sustainability and satisfaction Data are collected at four time points - baseline (T0, before training), post-intervention (T1, at the end of the training), 1-month follow-up (T2), and 6-month follow-up (T3) - using validated, self-administered, paper-based questionnaires, together with clinical assessment. Assessed domains include eHealth literacy, health literacy, self-efficacy in diabetes management, social integration and support, quality of life, DM severity and related clinical parameters, diabetes-related emotional distress, and participants' perceived satisfaction with the training. Continuous variables are reported as mean and standard deviation or median and interquartile range depending on distribution (assessed via Kolmogorov-Smirnov test); categorical variables as absolute numbers and percentages. Pre- and post-intervention comparisons use paired t-tests or Wilcoxon matched-pairs signed-rank tests for continuous outcomes, and Mann-Whitney U or Chi-square tests as appropriate. Analyses are performed using STATA or R. This study poses minimal risk to participants. Personal data are processed in anonymous, aggregate form in accordance with EU Regulation 2016/679 (GDPR) and Italian Legislative Decree No. 101/2018.
Study Type
OBSERVATIONAL
Enrollment
50
A structured, culturally adapted educational intervention aimed at improving eHealth literacy, health literacy, and self-management skills in Bangladeshi patients with type 2 diabetes. The training was co-designed with patients, family/community members, and healthcare stakeholders during a preparatory phase, based on the OPHELIA methodology and the ACCESS training model. It consists of 4 modules delivered in person at the diabetes center over 8 weeks (1 module every 15 days, approximately 120 minutes each), combining didactic teaching and interactive/practical sessions, with the support of a cultural mediator and diabetic peers. Topics include: type 2 diabetes awareness and management; principles of health literacy and eHealth literacy; use of digital health apps and tools; usability of technological devices and online health services; and self-evaluation of acquired knowledge and skills.
Azienda Ospedaliero Universitaria delle Marche (AOU Marche)
Ancona, March, Italy
Improvement of ehealth literacy among Bangladeshi type 2 diabetes patients
eHealth literacy will be assessed using the eHealth Literacy Scale (eHEALS), an 8-item measure of consumers' combined knowledge, comfort, and perceived skills in finding, evaluating, and applying electronic health information to health problems. The scale assesses the ability to access and use internet health information (items 1-5), judgment ability (items 6-7), and decision-making ability (item 8). Each item is rated on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree), with total scores ranging from 8 to 40; higher scores indicate greater eHealth literacy. The scale will be administered as a self-reported, paper-based tool, with support from a cultural mediator when needed, at baseline, at the end of the training intervention, and at 1-month and 6-month follow-up.
Time frame: Baseline (T0), end of intervention at 8 weeks (T1), 1-month follow-up (T2), and 6-month follow-up (T3)
Improvement of health literacy levels among paticipants
Health literacy will be assessed using the 16-item European Health Literacy Survey Questionnaire (HLS-EU-Q16), which measures health literacy across three domains: healthcare, disease prevention, and health promotion. Each item is answered by choosing one of four response options: "very difficult," "fairly difficult," "fairly easy," or "very easy." The questionnaire will be administered as a self-reported, paper-based tool, with support from a cultural mediator when needed, at baseline, at the end of the training intervention, and at 1-month and 6-month follow-up, to evaluate change over time.
Time frame: Baseline (T0), end of intervention at 8 weeks (T1), 1-month follow-up (T2), and 6-month follow-up (T3)
Improvement of Self-Efficacy in Diabetes Management (IT-DMSES)
Self-efficacy in diabetes management will be assessed using the Italian Diabetes Management Self-Efficacy Scale (IT-DMSES). The scale consists of 15 items divided into two factors: Factor 1, self-efficacy in diabetes management (e.g., medication adherence, glycaemic control), and Factor 2, self-efficacy in lifestyle management (e.g., eating behaviors, physical activity). Each factor score ranges from 0 to 10, with higher scores indicating greater self-efficacy (low: 0-3; mid: 4-6; high: 7-10). The scale will be administered as a self-reported, paper-based questionnaire, with support from a cultural mediator when needed, at baseline, at the end of the training intervention, and at 1-month and 6-month follow-up, to evaluate change over time.
Time frame: Baseline (T0), end of intervention at 8 weeks (T1), 1-month follow-up (T2), and 6-month follow-up (T3)
Improvement of Perceived Social Support and Integration (MSPSS)
Perceived social support and integration will be assessed using the Multidimensional Scale of Perceived Social Support (MSPSS), a 12-item self-reported questionnaire measuring perceived adequacy of social support from three sources: family, friends, and significant others. Each item is rated on a 5-point Likert scale ranging from 0 (strongly disagree) to 5 (strongly agree). The questionnaire will be administered as a self-reported, paper-based tool, with support from a cultural mediator when needed, at baseline and at 1-month follow-up, to evaluate change over time.
Time frame: Baseline (T0) and 1-month follow-up (T2)
Improvement of Quality of Life (EQ-5D-5L VAS)
Quality of life will be assessed using the EQ-5D-5L Visual Analogue Scale (VAS). The EQ-5D-5L consists of five dimensions - mobility, self-care, usual activities, pain/discomfort, and anxiety/depression - each rated across 5 severity levels (no problems, slight, moderate, severe, extreme problems). Participants indicate their health status by selecting the most appropriate level for each dimension, and additionally rate their overall health on the VAS, a vertical scale from 0 (worst imaginable health) to 100 (best imaginable health). The questionnaire will be administered as a self-reported, paper-based tool, with support from a cultural mediator when needed, at baseline, at the end of the training intervention, and at 1-month and 6-month follow-up, to evaluate change over time.
Time frame: Baseline (T0), end of intervention at 8 weeks (T1), 1-month follow-up (T2), and 6-month follow-up (T3)
Reduction of Diabetes-Related Emotional Distress (PAID)
Diabetes-related emotional distress will be assessed using the Problem Areas in Diabetes (PAID) questionnaire, a 20-item self-report scale measuring negative emotions related to diabetes (e.g., fear, anger, frustration). Each item is rated on a 5-point scale from 0 ("no problem") to 4 ("a serious problem"). The questionnaire will be administered as a self-reported, paper-based tool, with support from a cultural mediator when needed, at baseline, at the end of the training intervention, and at 1-month and 6-month follow-up, to evaluate change over time.
Time frame: Baseline (T0), end of intervention at 8 weeks (T1), 1-month follow-up (T2), and 6-month follow-up (T3)
Perceived utility, efficacy and effectiveness of the training (ad hoc questionnaire)
Participants' experience with the training will be assessed using an ad hoc, self-reported questionnaire developed specifically for this study, based on the target group and training modules. The questionnaire collects information on participants' overall satisfaction, perceived usefulness and effectiveness of the training, any benefits or limitations experienced, and suggestions for improvement. It will be administered as a paper-based tool, with support from a cultural mediator when needed, at the end of the training intervention.
Time frame: End of intervention, at 8 weeks (T1)
To evaluate the changes, after the intervention, in T2DM severity, through clinical records/physician visits.
This outcome will be assessed evaluating the change in the levels of Serum total cholesterol (mg/dl), triglycerides (mg/dl), High-Density Lipoproteins (mg/dl) and Low-Density Lipoproteins cholesterol (mg/dl).
Time frame: Baseline (T0), end of intervention at 8 weeks (T1), 1-month follow-up (T2), and 6-month follow-up (T3)
To evaluate the changes, after the intervention, in T2DM severity, through clinical records/physician visits.
This outcome will be assessed evaluating the change in waist circumference (cm)
Time frame: Baseline (T0), end of intervention at 8 weeks (T1), 1-month follow-up (T2), and 6-month follow-up (T3)
To evaluate the changes, after the intervention, in T2DM severity, through clinical records/physician visits.
This outcome will be assessed through evaluating the body weight (kg).
Time frame: Baseline (T0), end of intervention at 8 weeks (T1), 1-month follow-up (T2), and 6-month follow-up (T3)
To evaluate the changes, after the intervention, in T2DM severity, through clinical records/physician visits.
This outcome will be assessed evaluating the change Body Mass Index (BMI) (kg/m\^2).
Time frame: Baseline (T0), end of intervention at 8 weeks (T1), 1-month follow-up (T2), and 6-month follow-up (T3)
To evaluate the changes, after the intervention, in T2DM severity, through clinical records/physician visits.
This outcome will be assessed evaluating the change in the levels of glycated haemoglobin (HbA1c) - (mmol/mol)
Time frame: Baseline (T0), end of intervention at 8 weeks (T1), 1-month follow-up (T2), and 6-month follow-up (T3)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.