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Patient Reported Outcome Instruments in Sarcoidosis (OSAP-PRO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04342403
Recruitment Status : Unknown
Verified April 2020 by Robert P Baughman, University of Cincinnati.
Recruitment status was:  Recruiting
First Posted : April 13, 2020
Last Update Posted : April 13, 2020
Sponsor:
Collaborators:
Foundation for Sarcoidosis Research
Albany Medical College
Information provided by (Responsible Party):
Robert P Baughman, University of Cincinnati

Study Description
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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.

Condition or disease Intervention/treatment
Sarcoidosis Diagnostic Test: Quality of Life

Study Design
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Study Type : Observational
Estimated Enrollment : 350 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sarcoidosis

Groups and Cohorts
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Group/Cohort Intervention/treatment
Sarcoidosis
Patients with sarcoidosis willing to participate
 Diagnostic Test: Quality of Life
Quality of life instruments including King's Sarcoidosis Questionnaire (KSQ) and Sarcoidosis Assessment Tool (SAT)
Other Name: Pulmonary function testing


Outcome Measures
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Primary Outcome Measures :
  1. KSQ [ Time Frame: 6 months ]
    Change in KSQ


Secondary Outcome Measures :
  1. SAT [ Time Frame: 6 Months ]
    Change in SAT

  2. Visual Analog Scale (VAS) [ Time Frame: 6 Months ]
    Change in VAS

  3. Forced Vital Capacity (FVC) [ Time Frame: 6 months ]
    Change in FVC percent predicted


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients followed at sarcoidosis clinics across United States
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04342403


Locations
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United States, New York
Albany Medical Center Recruiting
Albany, New York, United States, 12208
Contact: Marc Judson, MD    518-262-5196    JudsonM@amc.edu   
United States, Ohio
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Robert P Baughman, MD    513-584-5225    bob.baughman@uc.edu   
Contact: Elyse E Lower    513-584-3829    ELower@ucmail.uc.edu   
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Dan Culver    216-444-2200    CULVERD@ccf.org   
Principal Investigator: Dan Culver         
Sponsors and Collaborators
University of Cincinnati
Foundation for Sarcoidosis Research
Albany Medical College
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Robert P Baughman, Professor, University of Cincinnati
ClinicalTrials.gov Identifier: NCT04342403    
Other Study ID Numbers: 2015-7046
First Posted: April 13, 2020    Key Record Dates
Last Update Posted: April 13, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: none at this time

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sarcoidosis
Lymphoproliferative Disorders
Lymphatic Diseases
 Hypersensitivity, Delayed
Hypersensitivity
Immune System Diseases