Patient Reported Outcome Instruments in Sarcoidosis

NCT ID: NCT04342403

Last Updated: 2020-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-01

Study Completion Date

2020-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Sarcoidosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Sarcoidosis

Patients with sarcoidosis willing to participate

Quality of Life

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Quality of Life

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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Pulmonary function testing

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Foundation for Sarcoidosis Research

OTHER

Sponsor Role collaborator

Albany Medical College

OTHER

Sponsor Role collaborator

University of Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Robert P Baughman

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Albany Medical Center

Albany, New York, United States

Site Status RECRUITING

University of Cincinnati

Cincinnati, Ohio, United States

Site Status RECRUITING

Cleveland Clinic

Cleveland, Ohio, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Marc Judson, MD

Role: primary

518-262-5196

Robert P Baughman, MD

Role: primary

513-584-5225

Elyse E Lower

Role: backup

513-584-3829

Dan Culver

Role: primary

216-444-2200

References

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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.

Reference Type DERIVED
PMID: 35358810 (View on PubMed)

Other Identifiers

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2015-7046

Identifier Type: -

Identifier Source: org_study_id

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