Patient Reported Outcome Instruments in Sarcoidosis
OSAP-PRO
Clinical Studies Network Research Trial: Development of an On-Line Sarcoidosis Assessment Platform (OSAP) to Validate Sarcoidosis Phenotypes and Monitor Disease Burden Longitudinally
1 other identifier
observational
350
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2017
Typical duration for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2017
CompletedFirst Submitted
Initial submission to the registry
April 8, 2020
CompletedFirst Posted
Study publicly available on registry
April 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedApril 13, 2020
April 1, 2020
3.7 years
April 8, 2020
April 8, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
KSQ
Change in KSQ
6 months
Secondary Outcomes (3)
SAT
6 Months
Visual Analog Scale (VAS)
6 Months
Forced Vital Capacity (FVC)
6 months
Study Arms (1)
Sarcoidosis
Patients with sarcoidosis willing to participate
Interventions
Quality of life instruments including King's Sarcoidosis Questionnaire (KSQ) and Sarcoidosis Assessment Tool (SAT)
Eligibility Criteria
Patients followed at sarcoidosis clinics across United States
You may qualify if:
- 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.
You may not qualify if:
- Life expectancy of \< 1 year.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Cincinnatilead
- Foundation for Sarcoidosis Researchcollaborator
- Albany Medical Collegecollaborator
Study Sites (3)
Albany Medical Center
Albany, New York, 12208, United States
University of Cincinnati
Cincinnati, Ohio, 45267, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Related Publications (1)
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.
PMID: 35358810DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 8, 2020
First Posted
April 13, 2020
Study Start
April 1, 2017
Primary Completion
December 1, 2020
Study Completion
December 1, 2020
Last Updated
April 13, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share
none at this time