E-Health Literacy Intervention for Bangladeshi Migrants With Type 2 Diabetes in Italy

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.

Inclusion criteria

• belonging to Bangladesh ethnicity
• affected by DM type 2 (as confirmed by the physician's diagnosis)
• Followed by the CAD of the capital province of Marche Region, Ancona, located in Azienda Ospedaliero Universitaria delle Marche
• aged >= 18 years old
• Capable of communicating verbally in local language (corresponding to a level of Italian language knowledge =>A2-CEFR level) (Council of Europe, 1996)
• without acute medical problems: myocardial infarction or stroke within 6 months, painful arthritis, spinal stenosis, amputation, painful foot lesions or neuropathy limiting balance and mobility, advanced Parkinson's disease and/or neuromuscular disorders, metastatic cancer, or immunosuppressive therapy, significant visual or hearing impairment, uncontrolled hypertension or other serious conditions that restrict their participation in the study.
• MMSE>= 24 (Folstein et al. 1975)
• PHQ-9=< 15 (Kroenke et al. 2001)
• with a low HL level, assessed by a scoring <=12 of HLS-EU-Q16 (Pelikan et al. 2017) and/or with low e-HL level, measured through e-HEALS (Norman & Skinner, 2006-II), assessed by a scoring <=29, and/or with low levels in self-efficacy, measured IT-DMSES (Messina et al. 2018), assessed by a scoring <4.
• capable to consent
• fulfilling the informed consent.

Exclusion criteria

• Failure to meet the inclusion criteria;
• Concomitant participation in other studies;
• Lack of written informed consent.