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Patient Reported Outcome Instruments in Sarcoidosis

Clinical Studies Network Research Trial: Development of an On-Line Sarcoidosis Assessment Platform (OSAP) to Validate Sarcoidosis Phenotypes and Monitor Disease Burden Longitudinally

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04342403
Acronym
OSAP-PRO
Enrollment
350
Registered
2020-04-13
Start date
2017-04-01
Completion date
2020-12-01
Last updated
2020-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sarcoidosis

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.

Interventions

DIAGNOSTIC_TESTQuality of Life

Quality of life instruments including King's Sarcoidosis Questionnaire (KSQ) and Sarcoidosis Assessment Tool (SAT)

Sponsors

Foundation for Sarcoidosis Research
CollaboratorOTHER
Albany Medical College
CollaboratorOTHER
University of Cincinnati
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

• Life expectancy of \< 1 year.

Design outcomes

Primary

MeasureTime frameDescription
KSQ6 monthsChange in KSQ

Secondary

MeasureTime frameDescription
SAT6 MonthsChange in SAT
Visual Analog Scale (VAS)6 MonthsChange in VAS
Forced Vital Capacity (FVC)6 monthsChange in FVC percent predicted

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026