Behçet DiseaseIMPACT_BDNCT05128357
IMPACT_BD (IMProving AdherenCe to Treatment in Behçet's Disease)
An observational study of Behçet Disease, run by Azienda Ospedaliero, Universitaria Pisana at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Behçet Disease
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- 16 Nov 2021to Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: At leads 300 patients with a diagnosis of Behçet's disease
Who may be able to join
- Diagnosis of Behçet's disease
Who cannot join
- BD patients < 18 years
Trial locations and contacts
1 site in 1 country.
Italy1 site
AOUPisana
Pisa, 56125
Rosaria Talarico, MD, PhD, +393383062729, sara.talarico76@gmail.com
Diana Marinello, +39 328 022 4868, info@behcetclinic-pisa.it
About this study
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
Read the 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.
- Conditions
- Behçet Disease
- Being tested
- the study is observational, no intervention foreseen
- Keywords
- Behçet, adherence to treatment, multistakeholder approach
- Medical subject headings
- Behcet Syndrome, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the study is observational, no intervention foreseenOther
the study does not foresees any intervention, since it is a multi step observational study.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From May 2022 to July 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start16 Nov 2021 (estimated)
- Primary completionJul 2022 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Behçet DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero, Universitaria Pisana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rosaria Talarico, Azienda Ospedaliero, Universitaria Pisana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05128357
- Sponsor's protocol ID
- RTalarico
- Acronym
- IMPACT_BD
- Status last verified
- Nov 2021
- First submitted
- 9 Nov 2021
- Last updated
- 22 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34663419Pirri 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.
PubMed 34596034
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMPACT_BD (IMProving AdherenCe to Treatment in Behçet's Disease)
- ClinicalTrials.gov ID
- NCT05128357
- Acronym / sponsor ID
- IMPACT_BD / RTalarico
- Conditions
- Behçet Disease
- Keywords
- Behçet, adherence to treatment, multistakeholder approach
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero, Universitaria PisanaUniversity, hospital or other
- Study start
- 16 Nov 2021 (estimated)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 22 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- At leads 300 patients with a diagnosis of Behçet's disease
Key inclusion criteria (1 listed)
- Diagnosis of Behçet's disease
Key exclusion criteria (1 listed)
- BD patients < 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the study is observational, no intervention foreseenthe study does not foresees any intervention, since it is a multi step observational study. | Other | – |
Primary outcome
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2021.
- Background: PubMed 34663419Talarico 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.
- Results publication: PubMed 34596034Pirri 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Behçet Disease, run by Azienda Ospedaliero, Universitaria Pisana at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To explore the unmet needs in treatment adherence in Behçet's disease patients (time frame: From November 2021 to middle May 2022). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05128357, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2021.