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

NCT07783893 | Active Not Recruiting

• 1 other identifier: 3736
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes; Diabete Mellitus

Keywords

eHealth literacy; Health literacy; Type 2 diabetes mellitus; Ethnic minority; Migrant health; Bangladeshi community; Culturally tailored education; Community-based participatory research; Equity

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (T0), end of intervention at 8 weeks (T1), 1-month follow-up (T2), and 6-month follow-up (T3)

Secondary Outcomes (11)

• Improvement of health literacy levels among paticipants

  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)

  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)

  Baseline (T0) and 1-month follow-up (T2)

• Improvement of Quality of Life (EQ-5D-5L VAS)

  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)

  Baseline (T0), end of intervention at 8 weeks (T1), 1-month follow-up (T2), and 6-month follow-up (T3)

Study Arms (1)

Bangladeshi patients with type 2 diabetes receiving the eHealth literacy training

Adults of Bangladeshi ethnicity with type 2 diabetes mellitus, followed by the diabetes center (CAD) of the University Hospital of the Marche Region in Ancona, meeting the study eligibility criteria. Participants receive a culturally adapted health literacy and eHealth literacy training intervention, co-designed with patients, family/community members, and healthcare stakeholders during a preparatory phase. The intervention consists of 4 modules delivered in person over 8 weeks (1 module every 15 days, approximately 120 minutes each), combining didactic and interactive methods with the support of a cultural mediator and diabetic peers. Modules cover: awareness of type 2 diabetes, health literacy and eHealth literacy principles; digital health tools and apps; usability of technological devices and online health services; and self-evaluation of acquired skills. Outcomes are assessed at baseline, post-intervention, and at 1- and 6-month follow-up.

Behavioral: Culturally Adapted eHealth Literacy Training Program

Interventions

Culturally Adapted eHealth Literacy Training Program BEHAVIORAL

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.

Bangladeshi patients with type 2 diabetes receiving the eHealth literacy training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults of Bangladeshi ethnicity with type 2 diabetes mellitus, residing in the Marche Region (Italy) and followed by the diabetes center (Centro Antidiabetico, CAD) of the University Hospital of the Marche Region (Azienda Ospedaliero-Universitaria delle Marche) in Ancona. Participants are recruited from among patients already in active follow-up at this clinic who wish to take part in the study and meet the eligibility criteria, including sufficient Italian language proficiency (CEFR level A2 or above), preserved cognitive status, absence of severe depressive symptoms, and low levels of health literacy, eHealth literacy, or self-efficacy in diabetes management. The Bangladeshi community is one of the largest ethnic minority groups in the Marche Region.

You may qualify if:

• 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.

You may not qualify if:

• Concomitant participation in other studies;
• Lack of written informed consent.

Sponsors & Collaborators

• Marche Region Regional Health Agency: lead

Study Sites (1)

Azienda Ospedaliero Universitaria delle Marche (AOU Marche)

Ancona, March, 60126, Italy

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2026
• First Posted: August 25, 2026
• Study Start: March 10, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 25, 2026

Record last verified: 2026-08

Locations

IT (1)