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

NCT05128357 | Unknown DMC

• 1 other identifier: RTalarico
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Behçet Disease

Keywords

Behçet; adherence to treatment; multistakeholder approach

Outcome Measures

Primary Outcomes (2)

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

  An ad hoc survey will be created in co-design with the different stakeholders in order to capture all the different dimensions, barriers and needs that are involved in the process of treatment adherence, as well to ensure the accessibility and understandability of the survey. The answers to the questions and the contributions provided in the narrative medicine section will be elaborated in order to identify the main barriers and unmet needs related to treatment adherence in BD patients and caregivers.

  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;

  he final tool will then be translated in different languages and will be adopted in a pilot phase that will involve at least 300 BD patients and caregivers form different countries. The results of the pilot phase will be discussed in the panel described in Phase A and the tool will be refined according to the results gathered in the pilot.

  From May 2022 to July 2022

Interventions

the study is observational, no intervention foreseen OTHER

the study does not foresees any intervention, since it is a multi step observational study.

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

At leads 300 patients with a diagnosis of Behçet's disease

You may qualify if:

• Diagnosis of Behçet's disease

You may not qualify if:

• BD patients \< 18 years

Sponsors & Collaborators

• Azienda Ospedaliero, Universitaria Pisana: lead

Study Sites (1)

AOUPisana

Pisa, 56125, Italy

Location

Related Publications (2)

• Talarico R, Marinello D, Manzo A, Cannizzo S, Palla I, Ticciati S, Gaglioti A, Trieste L, Pisa L, Badalamenti L, Randisi G, Del Bianco A, Lorenzoni V, Turchetti G, Mosca M. Being a caregiver of a Behcet's syndrome patient: challenges and perspectives during a complex journey. Orphanet J Rare Dis. 2021 Oct 18;16(1):436. doi: 10.1186/s13023-021-02070-2.

  PMID: 34663419 BACKGROUND

• Pirri S, Marinello D, Lorenzoni V, Andreozzi G, Bazzani A, Del Bianco A, Turchetti G, Mosca M, Talarico R. Adherence to treatment in Behcet's syndrome: a multi-faceted issue. Clin Exp Rheumatol. 2021 Sep-Oct;39 Suppl 132(5):88-93. doi: 10.55563/clinexprheumatol/1lx7a5. Epub 2021 Sep 30.

  PMID: 34596034 RESULT

MeSH Terms

Conditions

Behcet Syndrome; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Uveitis, Anterior; Panuveitis; Uveitis; Uveal Diseases; Eye Diseases; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Hereditary Autoinflammatory Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vascular; Health Behavior; Behavior

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: November 9, 2021
• First Posted: November 22, 2021
• Study Start: November 16, 2021
• Primary Completion: July 1, 2022
• Study Completion: November 1, 2022
• Last Updated: November 22, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)