Development of a Patient-Reported Outcome Measure to Assess Symptoms in Patients With Primary Sclerosing Cholangitis (PSC)
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|ClinicalTrials.gov Identifier: NCT02247934|
Recruitment Status : Completed
First Posted : September 25, 2014
Last Update Posted : February 9, 2016
|Condition or disease|
|Primary Sclerosing Cholangitis|
In Step I, concept elicitation one-on-one interviews (via telephone or in person) will be conducted. The aims of the concept elicitation interviews are to:
- Identify the most common symptoms, as well as the most important symptoms, for patients with PSC, and
- Assess whether these symptoms impact day-to-day functioning
An instrument will be developed based on the symptoms reported and in Step II of the study, the performance of the instrument will be assessed with further interviews.
|Study Type :||Observational|
|Actual Enrollment :||26 participants|
|Official Title:||Development of a Patient-Reported Outcome Measure to Assess Symptoms in Patients With Primary Sclerosing Cholangitis (PSC)|
|Study Start Date :||October 2014|
|Actual Primary Completion Date :||October 2015|
|Actual Study Completion Date :||October 2015|
Concept elicitation interviews (Step I)
Approximately 20 participants will be included.
Cognitive interviews (Step II)
Approximately 30 participants will be included.
- List Primary Sclerosing Cholangitis (PSC) Symptoms for inclusion in patient questionnaire [ Time Frame: Up to 12 months ]Interview participants to generate a list of the most common symptoms, as well as the most important symptoms, experienced by patients with PSC, and whether each symptom impacts day-to-day functioning.
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): NCT02247934
|United States, Colorado|
|University of Colorado Hospital, Denver Health Medical Center|
|Aurora, Colorado, United States, 80045|
|United States, Florida|
|University of Miami Miller School of Medicine - Schiff Center for Liver Diseases|
|Miami, Florida, United States, 33136|
|United States, Maryland|
|Bethesda, Maryland, United States, 20814|
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|United States, Washington|
|Organ Care Research Swedish Medical Center|
|Seattle, Washington, United States, 98104|
|Study Director:||Rob Myers, MD||Gilead Sciences|