Qualitative Research in Pediatric Patients and Their Parents/Caregivers to Develop a Patient-Reported Outcome (PRO) and Observer-Reported Outcome (ObsRO) Instruments in Crohn's Disease (CD)
We are conducting interviews with both caregivers of patients with CD and patients with CD between the ages of 5 and 17 years. Through these interviews, we will identify and explore the most important symptoms of CD experienced by children and adolescents. We want to understand how symptoms impact their lives and identify the specific language patients and their caregivers use to describe CD symptoms. With this data, we will create a conceptual model of CD, which will be used to develop a measure for Eli Lilly's clinical trials.
Eligible participants will:
- Be between the ages of 5 and 17 years with a clinical diagnosis of Crohn's Disease (CD) confirmed by sigmoidoscopy or colonoscopy. Alternatively, eligible participants may be a parent or caregiver of a child between the ages of 2 and 11 with clinically confirmed CD (as outlined above).
- Have clinician-confirmed CD that has been active in the past 90 days.
- Have signed and dated an Informed Consent Form and/or Assent and Parental Permission Forms.
- Be fluent in understanding, speaking, and reading US-English appropriate to participant's age.
Participants will be excluded if:
- They have a previous diagnosis of ulcerative colitis, indeterminate colitis, radiation colitis, or diverticular-associated colitis that could interfere with the participant's ability to evaluate the symptoms and impacts of their (or their child's) CD.
- They have had a procedure known as surgical resection that has significantly treated their CD.
- They have another significant or uncontrolled condition (e.g. cardiovascular, respiratory, gastrointestinal [excluding CD], neurological or neuropsychiatric disorders) that could, in the opinion of the investigator, prevent the participant's participation in this study or put the participant at an unacceptable risk for participating in this study.
- They are a member of the investigational site staff or family member of Lilly or COS staff directly involved in the conduct of the study.
- If the child/adolescent has a sibling who has also taken part in study EL1018-CD.
- If the parent of the participant (or co-parent if the participant is a parent/caregiver) has also taken part in the study EL1018-CD.
- The participant (either the parent/caregiver or child/adolescent) has any other medical or psychiatric condition that, in the opinion of the investigator, may interfere with participation in the study or interfere with the interpretation of the study results.
- Participant (either the parent/caregiver or child/adolescent) has a history of alcohol and/or drug abuse at any point in the past 12 months.
Clinical Outcomes Solutions is conducting in-person (or telephone) interviews to explore the experiences of children and adolescents with Crohn's Disease (CD) and/or their parents. The discussion will focus on the symptoms and impacts on quality of life due to CD. Parent and child interviews will be conducted separately. The results of this research will inform the development of a measure used in future clinical trials.
Description of Treatment or Intervention (Mechanism of Action)
This is an interview study, meaning there is no treatment offered in this research. We only want to talk to both caregivers of patients with CD who are between 2-11 years of age and patients with CD between the ages of 5-17 years of age.
Patient Participation Requirements
Participants are expected to participate in an interview. Prior to the interview, children will be asked to bring a collage that represents their CD to the interview, which will consist of pictures and drawings that represent their experiences of CD. This will be used to facilitate discussion during the interview.
Possible Risks & Side Effects
Their is no risk of physical harm to participants related to participating in this study. Participants may feel some discomfort sharing personal information about their experience with CD, however all information will be treated confidentially, and the interview will be conducted by a trained researcher.