VasculitisNCT03410290
Journey of Patients With Vasculitis From First Symptom to Diagnosis
An observational study of Vasculitis and Systemic Vasculitis, run by University of Pennsylvania at 1 site in United States.
Trial summary
This study seeks to understand the journey that patients eventually are diagnosed with vasculitis experience in the period prior to their formal diagnosis by a healthcare provider. Data elements of interest include average time from the onset of the first symptoms to the time a diagnosis of vasculitis is confirmed. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Vasculitis, Systemic Vasculitis, Behcet's Disease
- What is being tested?
- Online Questionnaire
- How many people
- 456 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jan 2018to 21 May 2018
- How long will I take part?
- 1 Day
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All individuals with self-reported vasculitis participating in the Vasculitis Patient-Powered Research Network (V-PPRN) will be invited to join the study, with a target recruitment period of 3 months. This study is open to US and international participants.
Who may be able to join
- Diagnosis of a systemic vasculitis: The V-PPRN includes patients with self-reported Behçet's disease, central nervous system vasculitis, cryoglobulinemic vasculitis, eosinophilic granulomatosis with polyangiitis (Churg-Strauss Syndrome, CSS), giant cell (temporal) arteritis (GCA), granulomatosis with polyangiitis (Wegener's, GPA), IgA vasculitis (Henoch-Schönlein Purpura), microscopic polyangiitis (MPA), polyarteritis nodosa (PAN), Takayasu's arteritis (TAK), and urticarial vasculitis.
- Language requirements: questionnaire will be in English only
Who cannot join
- Inability to provide informed consent and complete survey in English
- Patients with a diagnosis of "other" type of vasculitis
- Patients with a "missing" diagnosis -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Journey of Patients With Vasculitis From First Symptom to Diagnosis
This study seeks to understand the journey that patients eventually are diagnosed with vasculitis experience in the period prior to their formal diagnosis by a healthcare provider. Data elements of interest include average time from the onset of the first symptoms to the time a diagnosis of vasculitis is confirmed. Other aims include identifying factors associated with the time to diagnosis. These factors will be divided into: a) intrinsic factors, or so-called "patient-related factors", such as the type of vasculitis symptoms, patient demographics, socioeconomic status, patients' beliefs regarding the etiology of their symptoms, and other factors, and b) extrinsic factors, or "professional/health system factors", such as healthcare access, referral patterns, testing patterns, and other factors. Understanding such factors can guide future efforts to shorten delays in diagnosis and thereby improve outcomes. All analyses will be done for the population of patients with vasculitis as a whole and by individual types of vasculitis.
- Conditions
- Vasculitis, Systemic Vasculitis, Behcet's Disease, CNS Vasculitis, Cryoglobulinemic Vasculitis, Eosinophilic Granulomatous Vasculitis
- Being tested
- Online Questionnaire
- Medical subject headings
- Vasculitis, Systemic Vasculitis, Behcet Syndrome, Vasculitis, Central Nervous System, Cryoglobulinemia, Familial Mixed, Churg-Strauss Syndrome, Giant Cell Arteritis, Granulomatosis with Polyangiitis
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 factors that impacted a patients diagnosis of vasculitis.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | The online questionnaire includes questions about factors that impacted a patients diagnosis of vasculitis. Receives: Other: Online Questionnaire |
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 a delay in their disease diagnosis from initial symptoms of vasculitis to establishment of a diagnosis of vasculitis, stratified by disease type.
Analysis of how people fill in the questionnaire to determine the time from onset of symptoms of vasculitis to the first encounter with a healthcare provider for evaluation of those symptoms.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2018
- Study start11 Jan 2018
- Primary completion21 May 2018
- Study completion21 May 2018
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 PennsylvaniaThe 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 456 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Merkel, University of Pennsylvania
- Investigators
- Antoine Sreih, MD, Study chair, University of PennsylvaniaPeter A Merkel, MD, MPH, Study director, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03410290
- Sponsor's protocol ID
- VCRC5538/V-PPRN4
- Status last verified
- Jun 2018
- First submitted
- 18 Jan 2018
- Last updated
- 6 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Journey of Patients With Vasculitis From First Symptom to Diagnosis
- ClinicalTrials.gov ID
- NCT03410290
- Acronym / sponsor ID
- VCRC5538/V-PPRN4
- Conditions
- Vasculitis, Systemic Vasculitis, Behcet's Disease, CNS Vasculitis, Cryoglobulinemic Vasculitis, Eosinophilic Granulomatous Vasculitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 456 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 11 Jan 2018 (actual)
- Primary completion
- 21 May 2018 (actual)
- Study completion
- 21 May 2018 (actual)
- First posted
- 25 Jan 2018 (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.
This study seeks to understand the journey that patients eventually are diagnosed with vasculitis experience in the period prior to their formal diagnosis by a healthcare provider. Data elements of interest include average time from the onset of the first symptoms to the time a diagnosis of vasculitis is confirmed. Other aims include identifying factors associated with the time to diagnosis. These factors will be divided into: a) intrinsic factors, or so-called "patient-related factors", such as the type of vasculitis symptoms, patient demographics, socioeconomic status, patients' beliefs regarding the etiology of their symptoms, and other factors, and b) extrinsic factors, or "professional/health system factors", such as healthcare access, referral patterns, testing patterns, and other factors. Understanding such factors can guide future efforts to shorten delays in diagnosis and thereby improve outcomes. All analyses will be done for the population of patients with vasculitis as a whole and by individual types of vasculitis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: Online QuestionnaireThe online questionnaire includes questions about factors that impacted a patients diagnosis of vasculitis. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All individuals with self-reported vasculitis participating in the Vasculitis Patient-Powered Research Network (V-PPRN) will be invited to join the study, with a target recruitment period of 3 months. This study is open to US and international participants.
Key inclusion criteria (2 listed)
- Diagnosis of a systemic vasculitis: The V-PPRN includes patients with self-reported Behçet's disease, central nervous system vasculitis, cryoglobulinemic vasculitis, eosinophilic granulomatosis with polyangiitis (Churg-Strauss Syndrome, CSS), giant cell (temporal) arteritis (GCA), granulomatosis with polyangiitis (Wegener's, GPA), IgA vasculitis (Henoch-Schönlein Purpura), microscopic polyangiitis (MPA), polyarteritis nodosa (PAN), Takayasu's arteritis (TAK), and urticarial vasculitis.
- Language requirements: questionnaire will be in English only
Key exclusion criteria (3 listed)
- Inability to provide informed consent and complete survey in English
- Patients with a diagnosis of "other" type of vasculitis
- Patients with a "missing" diagnosis -
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 factors that impacted a patients diagnosis of vasculitis. | Other | Group 1 |
Primary outcome
Percentages of patients with different types of vasculitis who report a delay in their disease diagnosis from initial symptoms of vasculitis to establishment of a diagnosis of vasculitis, stratified by disease type.
Time frame: 1 day
Analysis of how people fill in the questionnaire to determine the time from onset of symptoms of vasculitis to the first encounter with a healthcare provider for evaluation of those symptoms.
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 6 Jun 2018.
- Vasculitis Patient-Powered Research NetworkLink provided by the sponsor.
- 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.
Antoine Sreih, MD study chair
University of Pennsylvania
Peter A Merkel, MD, MPH study director
University of Pennsylvania
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 Pennsylvania 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 2 inclusion and 3 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 6 Jun 2018. 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 a delay in their disease diagnosis from initial symptoms of vasculitis to establishment of a diagnosis of vasculitis, stratified by disease type. (time frame: 1 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 6 Jun 2018.