Behcet's DiseaseNCT02190929
Educational Needs of Patients With Systemic Vasculitis
An observational study of Behcet's Disease and Churg-Strauss Syndrome, run by University of South Florida at 1 site in United States.
Trial summary
A cross-sectional study design and online questionnaire was used to assess the informational needs of patients with several different types of systemic vasculitis. Patients were recruited from within the Vasculitis Clinical Research Consortium (VCRC) online Patient Contact Registry1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Behcet's Disease, Churg-Strauss Syndrome, Vasculitis, Central Nervous System
- How many people
- 386 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Feb 2014
- How long will I take part?
- 1 Year
- 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: Patients were recruited from within the Vasculitis Clinical Research Consortium (VCRC) Patient Contact Registry to participate in an online questionnaire. More than 3000 patients, representing all the different types of idiopathic vasculitis, are currently enrolled into the on-line registry. The different types of vasculitis available for study include: Behçets disease, Churg-Strauss Syndrome, CNS Vasculitis, Giant Cell Arteritis, granulomatosis with polyangiitis (Wegener's granulomatosis), Henoch-Schöenlein Purpura, Microscopic Polyangiitis, Polyarteritis Nodosa, or Takayasu's Arteritis.
Who may be able to join
- Enrolled in the VCRC Contact Registry
- Patient reported diagnosis of Behçets disease, Churg-Strauss Syndrome, CNS Vasculitis, Giant Cell Arteritis, granulomatosis with polyangiitis (Wegener's granulomatosis), Henoch-Schöenlein Purpura, Microscopic Polyangiitis, Polyarteritis Nodosa, Takayasu's Arteritis.
- 18 years of age or older
- English speaking
Who cannot join
- Inability to provide informed consent and complete survey
Trial locations and contacts
1 site in 1 country.
United States1 site
University of South Florida Data Management Coordinating Center
Tampa, Florida, 33612
About this study
Official title: Educational Needs of Patients With Systemic Vasculitis- an International Survey
A cross-sectional study design and online questionnaire was used to assess the informational needs of patients with several different types of systemic vasculitis. Patients were recruited from within the Vasculitis Clinical Research Consortium (VCRC) online Patient Contact Registry1. Survey responses from participants in the VCRC Patient Contact Registry were compared to responses from a similar survey recently administered to patients within a United Kingdom (UK) based vasculitis support group (Vasculitis UK).
Read the detailed description
All patients enrolled in the Vasculitis Clinical Research Consortium's Contact Registry were invited via email to participate in this study. The Contract Registry includes people who self-identify as having one of the following types of vasculitis: Behçets disease, Churg-Strauss Syndrome, CNS Vasculitis, Giant Cell Arteritis, granulomatosis with polyangiitis (Wegener's granulomatosis), Henoch-Schöenlein Purpura, Microscopic Polyangiitis, Polyarteritis Nodosa, or Takayasu's Arteritis. People voluntarily enroll in this Registry with the understanding that they will receive information about clinical studies for which they might be eligible. The introductory email included basic information about the study and all of the required elements for informed consent in a brief format. Once participants agreed to participate in the study, they were directed to the online questionnaire.
When completing the questionnaire, the patients were asked a series of questions. The questionnaire content was included as an appendix. The online questionnaire version was thoroughly tested for usability.
It was expected that most participants wouldrequire approximately 10-15 minutes to complete the questionnaire.
The survey data is stored by the Rare Diseases Clinical Research Network Data Management and Coordinating Center (DMCC) at the University of South Florida. The data is de-identified. Names or other personal health information were not collected.
- Conditions
- Behcet's Disease, Churg-Strauss Syndrome, Vasculitis, Central Nervous System, Giant Cell Arteritis, Wegener Granulomatosis, Henoch-Schoenlein Purpura
- Medical subject headings
- Behcet Syndrome, Churg-Strauss Syndrome, Vasculitis, Central Nervous System, Giant Cell Arteritis, Granulomatosis with Polyangiitis, IgA Vasculitis, Microscopic Polyangiitis, Polyarteritis Nodosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Vasculitis Contact Registry Patients | Patients will be recruited from within the Vasculitis Clinical Research Consortium (VCRC) Patient Contact Registry to participate in an online questionnaire. More than 3000 patients, representing all the different types of idiopathic vasculitis, are currently enrolled into the on-line registry. The different types of vasculitis available for study include: Behçets disease, Churg-Strauss Syndrome, CNS Vasculitis, Giant Cell Arteritis, granulomatosis with polyangiitis (Wegener's granulomatosis), Henoch-Schöenlein Purpura, Microscopic Polyangiitis, Polyarteritis Nodosa, or Takayasu's Arteritis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preferred method and component of education materials for patients with vasculitis
The outcome measure will be evaluated based on the cross-sectional online questionnaire. The questionnaire is the only study procedure for this online patient contact registry protocol and will be the sole analysis tool for the primary outcome measure.
Measured: Up to 24 months from the last patient assessment received
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2014 (estimated)
- Study startMar 2012
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behcet's 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 386 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Boston University, University of Pennsylvania, Data Management and Coordinating Center (DMCC)
- Responsible party
- Sponsor
- Investigators
- Richard A Watts, DM, Study chair, University of East AngliaJanice Mooney, M.Sc., Study chair, University of East AngliaPeter C. Grayson, MD, Study chair, Boston UniversityPeter A. Merkel, MD, MPH, Study chair, University of PennsylvaniaAmanda M. Terry, MA, Study chair, University of South Florida College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02190929
- Sponsor's protocol ID
- 5534
- Status last verified
- Jun 2014
- First submitted
- 30 May 2014
- Last updated
- 15 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Educational Needs of Patients With Systemic Vasculitis- an International Survey
- ClinicalTrials.gov ID
- NCT02190929
- Acronym / sponsor ID
- 5534
- Conditions
- Behcet's Disease, Churg-Strauss Syndrome, Vasculitis, Central Nervous System, Giant Cell Arteritis, Wegener Granulomatosis, Henoch-Schoenlein Purpura
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 386 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Collaborators
- Boston University, University of Pennsylvania, Data Management and Coordinating Center (DMCC)
- Study start
- Mar 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 15 Jul 2014 (estimated)
- 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.
A cross-sectional study design and online questionnaire was used to assess the informational needs of patients with several different types of systemic vasculitis. Patients were recruited from within the Vasculitis Clinical Research Consortium (VCRC) online Patient Contact Registry1. Survey responses from participants in the VCRC Patient Contact Registry were compared to responses from a similar survey recently administered to patients within a United Kingdom (UK) based vasculitis support group (Vasculitis UK).
Detailed description
All patients enrolled in the Vasculitis Clinical Research Consortium's Contact Registry were invited via email to participate in this study. The Contract Registry includes people who self-identify as having one of the following types of vasculitis: Behçets disease, Churg-Strauss Syndrome, CNS Vasculitis, Giant Cell Arteritis, granulomatosis with polyangiitis (Wegener's granulomatosis), Henoch-Schöenlein Purpura, Microscopic Polyangiitis, Polyarteritis Nodosa, or Takayasu's Arteritis. People voluntarily enroll in this Registry with the understanding that they will receive information about clinical studies for which they might be eligible. The introductory email included basic information about the study and all of the required elements for informed consent in a brief format. Once participants agreed to participate in the study, they were directed to the online questionnaire.
When completing the questionnaire, the patients were asked a series of questions. The questionnaire content was included as an appendix. The online questionnaire version was thoroughly tested for usability.
It was expected that most participants wouldrequire approximately 10-15 minutes to complete the questionnaire.
The survey data is stored by the Rare Diseases Clinical Research Network Data Management and Coordinating Center (DMCC) at the University of South Florida. The data is de-identified. Names or other personal health information were not collected.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vasculitis Contact Registry Patients | – | –Patients will be recruited from within the Vasculitis Clinical Research Consortium (VCRC) Patient Contact Registry to participate in an online questionnaire. More than 3000 patients, representing all the different types of idiopathic vasculitis, are currently enrolled into the on-line registry. The different types of vasculitis available for study include: Behçets disease, Churg-Strauss Syndrome, CNS Vasculitis, Giant Cell Arteritis, granulomatosis with polyangiitis (Wegener's granulomatosis), Henoch-Schöenlein Purpura, Microscopic Polyangiitis, Polyarteritis Nodosa, or Takayasu's Arteritis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients were recruited from within the Vasculitis Clinical Research Consortium (VCRC) Patient Contact Registry to participate in an online questionnaire. More than 3000 patients, representing all the different types of idiopathic vasculitis, are currently enrolled into the on-line registry. The different types of vasculitis available for study include: Behçets disease, Churg-Strauss Syndrome, CNS Vasculitis, Giant Cell Arteritis, granulomatosis with polyangiitis (Wegener's granulomatosis), Henoch-Schöenlein Purpura, Microscopic Polyangiitis, Polyarteritis Nodosa, or Takayasu's Arteritis.
Key inclusion criteria (4 listed)
- Enrolled in the VCRC Contact Registry
- Patient reported diagnosis of Behçets disease, Churg-Strauss Syndrome, CNS Vasculitis, Giant Cell Arteritis, granulomatosis with polyangiitis (Wegener's granulomatosis), Henoch-Schöenlein Purpura, Microscopic Polyangiitis, Polyarteritis Nodosa, Takayasu's Arteritis.
- 18 years of age or older
- English speaking
Key exclusion criteria (1 listed)
- Inability to provide informed consent and complete survey
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Preferred method and component of education materials for patients with vasculitis
Time frame: Up to 24 months from the last patient assessment received
The outcome measure will be evaluated based on the cross-sectional online questionnaire. The questionnaire is the only study procedure for this online patient contact registry protocol and will be the sole analysis tool for the primary outcome measure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2014.
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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.
Richard A Watts, DM study chair
University of East Anglia
Janice Mooney, M.Sc. study chair
University of East Anglia
Peter C. Grayson, MD study chair
Boston University
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 Behcet's Disease and Churg-Strauss Syndrome, run by University of South Florida at 1 site in United States.
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 4 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: finished, as of the sponsor's last update on 15 Jul 2014. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preferred method and component of education materials for patients with vasculitis (time frame: Up to 24 months from the last patient assessment received). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jul 2014.