UnknownNot Applicable

IMPACT_BD (IMProving AdherenCe to Treatment in Behçet's Disease)

Italy300 participantsStarted 2021-11-16

Plain-language summary

Behçet's disease (BD) is an autoimmune, rare, and severe multisystemic inflammatory disease characterized by recurrent oral aphthous ulcers, genital ulcers, skin lesions, and both anterior and posterior uveitis; articular, vascular, gastroenteric and neurological involvement may also occur. The multi-organ involvement and the wide range of clinical spectrum make the diagnosis of BD challenging. Adherence has been defined as the "extent to which a person's behavior (in terms of taking medications, following diets, or executing other lifestyle changes) corresponds with agreed recommendations from a health care provider". The lack of medication adherence leads to poorer health outcomes for the patients, which affect quality of life, generate economic loss for the healthcare system and trigger uncertainty for the healthcare prescribers in dealing with the disease treatment. This challenge is particularly important in BD. The present study is therefore aimed at exploring the main reasons for low- or non-adherence to treatments in BD and to create a specific tool able to catch and monitor the reasons for low- or non-adherence in BD over time. Objectives * to explore the unmet needs in treatment adherence * to create a toll aimed at identifying and monitoring the reasons of low treatment adherence * to plan specific actions aimed at improving treatment adherence in BD

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: * Diagnosis of Behçet's disease Exclusion Criteria: * BD patients \< 18 years

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.

1This IMPACT_BD study seems focused on understanding why Behçet's disease patients struggle to stick to their treatments — could participating help identify specific barriers I personally face with my own medication routine, and how would that information actually be used?
2Since this trial is listed as 'Phase NA,' it appears to be a research or observational study rather than a drug trial — can you explain what that means for me in terms of what I'd actually be asked to do, and whether there are any risks involved?
3The study aims to co-design a new tool to measure why patients don't adhere to their Behçet's treatment — would taking part in this kind of research realistically take time away from managing my current care, and how much of a commitment would it be?
4Given that my current treatment adherence might already be a challenge, is there anything in my specific situation — like the type of Behçet's symptoms I have or the medications I'm on — that would make my input particularly relevant or useful to this study?
5Since this trial's recruitment status is listed as 'unknown,' do you know whether it is still actively enrolling patients, and if not, are there other similar research efforts focused on improving Behçet's disease treatment adherence that I could consider instead?

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

To explore the unmet needs in treatment adherence in Behçet's disease patients

Timeframe: From November 2021 to middle May 2022

The creation of a co-designed tool aimed at assessing the causes and barriers of low- or non adherence in BD patients;

Timeframe: From May 2022 to July 2022

Trial details

NCT IDNCT05128357

SponsorAzienda Ospedaliero, Universitaria Pisana

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-07

View on ClinicalTrials.gov More Behçet Disease trials

Plain-language summary