SarcoidosisOSAP-PRONCT04342403
Patient Reported Outcome Instruments in Sarcoidosis
An observational study of Sarcoidosis, run by University of Cincinnati at 3 sites in United States.
Trial summary
Evaluate change of quality of life of sarcoiodosis patients over a six months using various quality of life instruments including a monthly smart phone app. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoidosis
- What is being tested?
- Quality of Life
- How many people
- 350 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Apr 2017to 1 Dec 2020
- 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 followed at sarcoidosis clinics across United States
Who may be able to join
- Diagnosis of sarcoidosis by established criteria.
- Patient has completed pulmonary function tests (spirometry) as per standard of care at the enrollment visit.
- Ability to understand and read English at least at a 7th grade level.
- Have access to a computer, iPad, smart phone, or another electronic device that will support the on-line sarcoidosis assessment platform.
- The subject is willing to wear a daily activity and sleep tracker wristband (Fitbit ™ wristband) for 6 months.
Who cannot join
- Life expectancy of < 1 year.
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Recruiting
Albany Medical Center
Albany, New York, 12208
Marc Judson, MD, 518-262-5196, JudsonM@amc.edu
- Recruiting
University of Cincinnati
Cincinnati, Ohio, 45267
Robert P Baughman, MD, 513-584-5225, bob.baughman@uc.edu
Elyse E Lower, 513-584-3829, ELower@ucmail.uc.edu
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Dan Culver, 216-444-2200, CULVERD@ccf.org
Dan Culver
About this study
Official title: Clinical Studies Network Research Trial: Development of an On-Line Sarcoidosis Assessment Platform (OSAP) to Validate Sarcoidosis Phenotypes and Monitor Disease Burden Longitudinally
Evaluate change of quality of life of sarcoiodosis patients over a six months using various quality of life instruments including a monthly smart phone app.
- Conditions
- Sarcoidosis
- Being tested
- Quality of Life
- Medical subject headings
- Sarcoidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of LifeDiagnostic test
Also called Pulmonary function testing
Quality of life instruments including King's Sarcoidosis Questionnaire (KSQ) and Sarcoidosis Assessment Tool (SAT)
| Study group | Role | What they receive |
|---|---|---|
| Sarcoidosis | Patients with sarcoidosis willing to participate Receives: Diagnostic Test: Quality of Life |
What is being measured
The primary outcome is the main question the study is designed to answer.
KSQ
Change in KSQ
Measured: 6 months
Secondary outcomes (3)
SAT
Change in SAT
Measured: 6 Months
Visual Analog Scale (VAS)
Change in VAS
Measured: 6 Months
Forced Vital Capacity (FVC)
Change in FVC percent predicted
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2020
- Study start1 Apr 2017
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcoidosisStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe 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
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation for Sarcoidosis Research, Albany Medical College
- Responsible party
- Principal investigator, Robert P Baughman, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04342403
- Sponsor's protocol ID
- 2015-7046
- Acronym
- OSAP-PRO
- Status last verified
- Apr 2020
- First submitted
- 8 Apr 2020
- Last updated
- 13 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: none at this time
Publications
Judson MA, Yucel R, Preston S, Chen ES, Culver DA, Hamzeh N, Lower EE, Sweiss NJ, Valeyre D, Veltkamp M, Victorson DE, Beaumont JL, Singh N, Shivas T, Vancavage R, Baughman RP. The association of baseline sarcoidosis measurements with 6-month outcomes that are of interest to patients: Results from the On-line Sarcoidosis Assessment Platform Study (OSAP). Respir Med. 2022 May;196:106819. doi: 10.1016/j.rmed.2022.106819. Epub 2022 Mar 18.
PubMed 35358810
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Studies Network Research Trial: Development of an On-Line Sarcoidosis Assessment Platform (OSAP) to Validate Sarcoidosis Phenotypes and Monitor Disease Burden Longitudinally
- ClinicalTrials.gov ID
- NCT04342403
- Acronym / sponsor ID
- OSAP-PRO / 2015-7046
- Conditions
- Sarcoidosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- Foundation for Sarcoidosis Research, Albany Medical College
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 13 Apr 2020 (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.
Evaluate change of quality of life of sarcoiodosis patients over a six months using various quality of life instruments including a monthly smart phone app.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sarcoidosis | – | Diagnostic Test: Quality of LifePatients with sarcoidosis willing to participate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients followed at sarcoidosis clinics across United States
Key inclusion criteria (5 listed)
- Diagnosis of sarcoidosis by established criteria.
- Patient has completed pulmonary function tests (spirometry) as per standard of care at the enrollment visit.
- Ability to understand and read English at least at a 7th grade level.
- Have access to a computer, iPad, smart phone, or another electronic device that will support the on-line sarcoidosis assessment platform.
- The subject is willing to wear a daily activity and sleep tracker wristband (Fitbit ™ wristband) for 6 months.
Key exclusion criteria (1 listed)
- Life expectancy of < 1 year.
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 |
|---|---|---|
| Quality of LifeAlso: Pulmonary function testingQuality of life instruments including King's Sarcoidosis Questionnaire (KSQ) and Sarcoidosis Assessment Tool (SAT) | Diagnostic test | Sarcoidosis |
Primary outcome
KSQ
Time frame: 6 months
Change in KSQ
3 secondary outcomes
SAT
Time frame: 6 Months
Visual Analog Scale (VAS)
Time frame: 6 Months
Forced Vital Capacity (FVC)
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2020.
- Derived from this study: PubMed 35358810Judson MA, Yucel R, Preston S, Chen ES, Culver DA, Hamzeh N, Lower EE, Sweiss NJ, Valeyre D, Veltkamp M, Victorson DE, Beaumont JL, Singh N, Shivas T, Vancavage R, Baughman RP. The association of baseline sarcoidosis measurements with 6-month outcomes that are of interest to patients: Results from the On-line Sarcoidosis Assessment Platform Study (OSAP). Respir Med. 2022 May;196:106819. doi: 10.1016/j.rmed.2022.106819. Epub 2022 Mar 18.
- Individual participant dataSharing planned: No. none at this time
Related trials for Sarcoidosis
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
Not yet recruitingPhase 2
An Efficacy Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis With or Without Extrapulmonary Manifestations
Pulmonary Sarcoidosis
RecruitingPhase 2/3
A Study of Brepocitinib in Adults With Cutaneous Sarcoidosis
Cutaneous Sarcoidosis
Not yet recruitingPhase 2
LAM-001 for the Treatment of Sarcoidosis Associated Pulmonary Hypertension (SAPH)
Sarcoidosis Associated Pulmonary Hypertension
RecruitingObservational study
Prognostic Value of Clinical Cardiovascular MRI
Sarcoidosis
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcoidosis, run by University of Cincinnati at 3 sites 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: status not confirmed, as of the sponsor's last update on 13 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
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?
KSQ (time frame: 6 months). 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 NCT04342403, which also lists 1 linked publication.
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 13 Apr 2020.