Patient Reported Outcome Instruments in Sarcoidosis

Sarcoidosis Clinical Trial

— OSAP-PRO  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04342403
• Other study ID #: 2015-7046
• Status: Recruiting
• Start date: April 1, 2017
• Est. completion date: December 1, 2020

Study information

• Verified date: April 2020
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: December 1, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Sarcoidosis

Intervention

Diagnostic Test:
• Quality of Life
Quality of life instruments including King's Sarcoidosis Questionnaire (KSQ) and Sarcoidosis Assessment Tool (SAT)

Locations

Country	Name	City	State
United States	Albany Medical Center	Albany	New York
United States	University of Cincinnati	Cincinnati	Ohio
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
University of Cincinnati	Albany Medical College, Foundation for Sarcoidosis Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	KSQ	Change in KSQ	6 months
Secondary	SAT	Change in SAT	6 Months
Secondary	Visual Analog Scale (VAS)	Change in VAS	6 Months
Secondary	Forced Vital Capacity (FVC)	Change in FVC percent predicted	6 months