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

November 9, 2021 updated by: Rosaria Talarico, Azienda Ospedaliero, Universitaria Pisana

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Methodology The methodology includes 5 consequent phases, summarized below. Phase A. Panel creation - The first step foresees the creation of a multi-stakeholder panel, that will include clinicians, BD patients' representatives, BD caregiver' representatives and other experts (economists, psychologist, pharmacists, etc). The multi-stakeholder approach will contribute to improve the identification of the different barriers, perspectives and unmet needs of the different stakeholders and to identify the patients' outcomes to be included in the tool. The panel will be created by launching an international call for interest.

Phase B. Co-design process - 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 survey will include two main sections: one section with questions and a section dedicated to narrative medicine, that will provide a limited space for patients and caregivers to express their perspective, views, needs and priorities in terms of treatment adherence.

The survey will be translated in different languages to ensure a wide dissemination across different countries.

Phase C. Launch of the survey - This phase foresees the upload of the survey into the EU Survey and the launch of the survey across the different centers involved in the study.

BD patients and caregivers will be able to access the survey online for at least 3 months in order to reach the greatest number possible of respondents.

Phase D. Data analysis, workshop and agreement - 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.

In addition, an online workshop will be organized in order to:

  • elaborate and discuss the results of the survey;
  • co-design and reach a formal agreement on the tool that will enable the identification and the monitoring of BD treatment adherence during the clinical follow-up of BD patients.

Phase E. Pilot phase for validation - The 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. The final tool will then be published in a scientific paper and distributed to BD experts and patients' organisations for adoption. In addition, based on the results of the pilot phase, a list of future actions aimed at improving treatment adherence in BD patients will be produced with the support of members of the co-design panel organized in Phase A.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • Diagnosis of Behçet's disease

Exclusion Criteria:

  • BD patients < 18 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To explore the unmet needs in treatment adherence in Behçet's disease patients
Time Frame: From November 2021 to middle May 2022
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;
Time Frame: From May 2022 to July 2022
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliero, Universitaria Pisana

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 16, 2021

Primary Completion (Anticipated)

July 1, 2022

Study Completion (Anticipated)

November 1, 2022

Study Registration Dates

First Submitted

November 9, 2021

First Submitted That Met QC Criteria

November 9, 2021

First Posted (Actual)

November 22, 2021

Study Record Updates

Last Update Posted (Actual)

November 22, 2021

Last Update Submitted That Met QC Criteria

November 9, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RTalarico

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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