CompletedNot Applicable

Cardio-metabolic Diseases in Immigrants and Ethnic Minorities: From Epidemiology to New Prevention Strategies

Italy202 participantsStarted 2023-11-07

Plain-language summary

The purpose of this clinical trial is to learn if intervention on health behavior can promote diabetes care and improve compliance to therapeutic protocols in ethnic minorities with type 2 diabetes. To answer this question, researchers will compare the effectiveness of co-created, culture-sensitive intervention to that of a usual-care approach to promote diabetes care 12 months after enrollment in first-generation immigrants with type 2 diabetes.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Immigrant status: Self-identification of being born in High migration pressure countries from parents born in high migration pressure countries * Age ≥ 18 years * Type 2 diabetes newly diagnosed or with HbA1c \> 8% in the last assessment within 24 months before the visit Exclusion Criteria: * Patients who will not provide the informed consent * Patients with HbA1c ≤ 8% in the last assessment within 24 months before the visit * Severe psychiatric disorders * Pregnant women * Critical illness * Impaired cognitive or physical ability that could make the intervention not feasible, as judged by clinical staff members

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Glycated haemoglobin (HbA1c)

Timeframe: from baseline to follow-up at month 12

Trial details

NCT IDNCT06131411

SponsorAzienda Ospedaliero-Universitaria Careggi

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10-31

View on ClinicalTrials.gov More Diabetes Mellitus, Type 2 trials