VasculitisNCT02476292
Impact of Vasculitis on Employment and Income
An observational study of Vasculitis and Systemic Vasculitis, run by University of South Florida at 1 site in United States.
Trial summary
The purpose of this study is to learn about the impact of vasculitis on employment and income in patients with different systemic vasculitides. All patients enrolled in the Vasculitis Clinical Research Consortium (VCRC) Patient Contact Registry, living in USA or Canada, and followed for more than 1 year since the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vasculitis, Systemic Vasculitis, Behcet's Disease
- What is being tested?
- online questionnaire
- How many people
- 426 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Jan 2016
- 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: All individuals with vasculitis participating in the VCRC Patient Contact Registry, living in the USA or Canada, and with a follow-up period ≥1 year since the diagnosis of vasculitis.
Who may be able to join
- Diagnosis of a systemic vasculitis: VCRC Patient Contact Registry includes patients with Behcet's disease, CNS vasculitis, Cryoglobulinemic vasculitis (Cryoglobulinemia), eosinophilic granulomatosis with polyangiitis (Churg-Strauss) (CSS), giant cell (temporal) arteritis (GCA), granulomatosis with polyangiitis (Wegener's) (GPA), Henoch-Schönlein purpura (IgA vasculitis), microscopic polyangiitis (MPA), polyarteritis nodosa (PAN), Takayasu arteritis (TAK), and urticarial vasculitis.
- Age ≥18 years old
- Living in USA or Canada
- Vasculitis diagnosis made ≥1 year ago
- Language requirements: questionnaire will be in English only
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 and Coordinating Center
Tampa, Florida, 33612
About this study
Official title: Impact of Vasculitis on Employment and Income. An Online Survey of Participants in the VCRC Patient Contact Registry
The purpose of this study is to learn about the impact of vasculitis on employment and income in patients with different systemic vasculitides. All patients enrolled in the Vasculitis Clinical Research Consortium (VCRC) Patient Contact Registry, living in USA or Canada, and followed for more than 1 year since the vasculitis diagnosis will be invited via email to participate in this study, based on an online survey.
Read the detailed description
All individuals with vasculitis participating in the VCRC contact patient registry, living in the USA or Canada, and with a follow-up period of ≥1 year since the diagnosis of vasculitis will be invited by email to complete an online questionnaire. They will be asked several questions about their disease, their employment and work status before diagnosis and over the course of their disease, their work capacity and the financial impact on their lives.
The survey data will be stored by the Rare Diseases Clinical Research Network's Data Management and Coordinating Center (DMCC) at the University of South Florida. The data will be de-identified. Names or other personal health information will not be collected. If a participant is enrolled in the Vasculitis Patient-Powered Research Network (V-PPRN) University of South Florida (USF) Institutional Review Board Pro00018514, the participant can choose to provide their email address. Upon conclusion of the study period, the data will be sent to the VCRC Principal Investigator and the Protocol 5536 Co-Principal Investigators. All data collected will be sent to the database of Genotypes and Phenotypes (dbGaP) to be stored indefinitely per the Rare Disease Clinical Research Network (RDCRN) Data Sharing Policy.
- Conditions
- Vasculitis, Systemic Vasculitis, Behcet's Disease, CNS Vasculitis, Cryoglobulinemic Vasculitis, Eosinophilic Granulomatosis
- Being tested
- online questionnaire
- Medical subject headings
- Vasculitis, Systemic Vasculitis, Behcet Syndrome, Vasculitis, Central Nervous System, Cryoglobulinemia, Familial Mixed, Giant Cell Arteritis, Granulomatosis with Polyangiitis, IgA Vasculitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
online questionnaireOther
The online questionnaire includes questions about vasculitis, employment and work status before diagnosis and over the course of the disease, work capacity and the financial impact of vasculitis.
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentages of patients with different types of vasculitis who report negative impact of the disease on employment status, productivity, and income.
Self-reported change in employment status, productivity, and income from the time of diagnosis to the present.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VasculitisStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe sponsor's other registered studies.
- 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
- Time perspective
- Prospective
- Enrolment
- 426 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- University of Western Ontario, Canada, University of Pennsylvania, University of Toronto
- Responsible party
- Sponsor
- Investigators
- Christian Pagnoux, MD, MPH, MSc, Study chair, University of TorontoPeter A. Merkel, MD, MPH, Study chair, University of PennsylvaniaLillian Barra, MD, PhD, Study chair, University of Western Ontario, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02476292
- Sponsor's protocol ID
- VCRC 5536
- Status last verified
- Jan 2016
- First submitted
- 12 Jun 2015
- Last updated
- 28 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Vasculitis on Employment and Income. An Online Survey of Participants in the VCRC Patient Contact Registry
- ClinicalTrials.gov ID
- NCT02476292
- Acronym / sponsor ID
- VCRC 5536
- Conditions
- Vasculitis, Systemic Vasculitis, Behcet's Disease, CNS Vasculitis, Cryoglobulinemic Vasculitis, Eosinophilic Granulomatosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 426 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Collaborators
- University of Western Ontario, Canada, University of Pennsylvania, University of Toronto
- Study start
- Jun 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 19 Jun 2015 (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.
The purpose of this study is to learn about the impact of vasculitis on employment and income in patients with different systemic vasculitides. All patients enrolled in the Vasculitis Clinical Research Consortium (VCRC) Patient Contact Registry, living in USA or Canada, and followed for more than 1 year since the vasculitis diagnosis will be invited via email to participate in this study, based on an online survey.
Detailed description
All individuals with vasculitis participating in the VCRC contact patient registry, living in the USA or Canada, and with a follow-up period of ≥1 year since the diagnosis of vasculitis will be invited by email to complete an online questionnaire. They will be asked several questions about their disease, their employment and work status before diagnosis and over the course of their disease, their work capacity and the financial impact on their lives.
The survey data will be stored by the Rare Diseases Clinical Research Network's Data Management and Coordinating Center (DMCC) at the University of South Florida. The data will be de-identified. Names or other personal health information will not be collected. If a participant is enrolled in the Vasculitis Patient-Powered Research Network (V-PPRN) University of South Florida (USF) Institutional Review Board Pro00018514, the participant can choose to provide their email address. Upon conclusion of the study period, the data will be sent to the VCRC Principal Investigator and the Protocol 5536 Co-Principal Investigators. All data collected will be sent to the database of Genotypes and Phenotypes (dbGaP) to be stored indefinitely per the Rare Disease Clinical Research Network (RDCRN) Data Sharing Policy.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All individuals with vasculitis participating in the VCRC Patient Contact Registry, living in the USA or Canada, and with a follow-up period ≥1 year since the diagnosis of vasculitis.
Key inclusion criteria (5 listed)
- Diagnosis of a systemic vasculitis: VCRC Patient Contact Registry includes patients with Behcet's disease, CNS vasculitis, Cryoglobulinemic vasculitis (Cryoglobulinemia), eosinophilic granulomatosis with polyangiitis (Churg-Strauss) (CSS), giant cell (temporal) arteritis (GCA), granulomatosis with polyangiitis (Wegener's) (GPA), Henoch-Schönlein purpura (IgA vasculitis), microscopic polyangiitis (MPA), polyarteritis nodosa (PAN), Takayasu arteritis (TAK), and urticarial vasculitis.
- Age ≥18 years old
- Living in USA or Canada
- Vasculitis diagnosis made ≥1 year ago
- Language requirements: questionnaire will be in English only
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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| online questionnaireThe online questionnaire includes questions about vasculitis, employment and work status before diagnosis and over the course of the disease, work capacity and the financial impact of vasculitis. | Other | – |
Primary outcome
Percentages of patients with different types of vasculitis who report negative impact of the disease on employment status, productivity, and income.
Time frame: one day
Self-reported change in employment status, productivity, and income from the time of diagnosis to the present.
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 28 Jan 2016.
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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.
Christian Pagnoux, MD, MPH, MSc study chair
University of Toronto
Peter A. Merkel, MD, MPH study chair
University of Pennsylvania
Lillian Barra, MD, PhD study chair
University of Western Ontario, Canada
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 Vasculitis and Systemic Vasculitis, 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 5 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 28 Jan 2016. 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?
Percentages of patients with different types of vasculitis who report negative impact of the disease on employment status, productivity, and income. (time frame: one day). 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 28 Jan 2016.