Qualitative Research to Explore Bowel Urgency and Disease Remission in Adults with Ulcerative Colitis

Published: 10/02/2020

General Information:

Study Objective
  • We are conducting interviews with adults who have been clinically diagnosed with Ulcerative Colitis (UC) that is currently moderately-to-severely active based on clinician assessment.
  • The focus of the interviews will be to gain a better understanding of the participant's experience living with ulcerative colitis, including what symptoms are most important to them and how these symptoms may impact their day-to-day life.
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Eligibility:

Age
Adult (18+)
Gender
Female
Male
Disease Type
Ulcerative Colitis
Severity
Moderate
Severe
Eligibility Criteria

Inclusion criteria 

  • Participant is aged ≥ 18 years.
  • Participant has UC confirmed by sigmoidoscopy or colonoscopy ≥ 3 months ago.
  • Participant's current UC is rated moderately-severely active as rated by recruiting physician.
  • Participant has a signed and dated informed consent and is fluent in understanding, speaking and reading US-English.
  • Participant is willing and able to attend a telephone/face-to-face interview session and to have that interview audio recorded. 

Exclusion criteria 

  • Participant has a previous diagnosis of Crohn's disease, indeterminate colitis, radiation colitis or diverticular-associated colitis that could interfere with the participant's ability to evaluate the symptoms and impacts of their ulcerative colitis.
  • Participant has had surgical resection that has significantly treated their ulcerative colitis.
  • Participant has any other medical or psychiatric condition that, in the opinion of the investigator, may interfere with participation in the study, interfere with the interpretation of the study results or result in an unacceptable risk to the participant for participating in the study.
  • Participant is a member of the investigational site staff, or family member of the investigational site staff directly involved in the conduct of the study from Lilly or Clinical Outcomes Solutions.
  • Participant, or family member of participant, has been directly involved in a previous Lilly or Clinical Outcomes Solutions study relating to UC.
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Study Details:

Study Description

  • Clinical Outcomes Solutions is conducting telephone interviews with adults 18 years of age or older to gain a better understanding of the participant's experience living with ulcerative colitis.
  • The interview will include discussion of their experience of symptoms related to ulcerative colitis including how often these types of symptoms are experienced.
  • The results of this research will inform a measure developed by the sponsor that is being used in their clinical trials.

Description of treatment or intervention (mechanism of action)

  • This is an interview study.
  • There is no treatment included in this research.
  • We only want to talk to adult participants who have been diagnosed with ulcerative colitis. 

Patient Participation Requirements

  • Participants are expected to participate and complete an interview expecting to last approximately 90 minutes.

Possible risks and side effects

  • There is no risk of physical harm related to participating in this study.
  • The participants may feel some discomfort sharing personal information about their experience with ulcerative colitis; however, all information will be treated confidentially and the interview will be conducted by a trained researcher. 

 

 

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Contact Information:

Site Locations

Clinical Outcomes Solutions 1820 East River Road Suite #220 Tucson, Arizona 85718
Trina Soileau
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