Application of Cellie Coping Kits in Pediatric Patients with Eosinophilic Esophagitis (EoE)

P
Paroma Bose, MD

Primary Investigator

Enrolling By Invitation
2 years - 18 years
All
Phase N/A
25 participants needed
2 Locations

Brief description of study

What is the purpose of this study?

The aim of this study is to measure the efficacy of the Cellie Coping Kit in pediatric patients with EoE.  Furthermore, an additional aim is to determine if there is variation in the kit’s efficacy among patients being treated with diet elimination versus medications or combination therapy.

THIS STUDY IS ENROLLING BY INVITATION ONLY - Patients will be identified and recruited by the research team for study participation as they come into Riley Hospital for Children’s Gastroenterology clinic (at either Riley Hospital or IUN) for an established diagnosis of EoE. 

Detailed description of study

What will happen during the study?
1) Eligible subjects for this study are pediatric subjects with a diagnosis of eosinophilic esophagitis. 
2) Subjects with a clinic visit indication of eosinophilic esophagitis will be approached for participation upon arrival at a Riley GI clinic at Riley Hospital for Children or IU North Hospital. 
3) At the initial clinic visit, eligible patients and their parents/guardians will be informed about the study with a consent form. 
4) If they agree to participate in the study, the patient or their parents/guardians will fill out an initial Peds EoE Quality of Life (QL) survey to assess symptom presence, frequency, and severity.  (For participants < 5 years of age, parents/guardians will complete the surveys.) 
5) The patient and caregiver will be provided with a Cellie Coping Kit, which includes a plush Cellie toy, a deck of coping cards, and a guide for caregivers in a drawstring bag. 
6) The PedsQL survey will be readministered 4-8 weeks after the initial clinic visit. A paper version of this survey along with pre-addressed and stamped envelope will be included in the kit to be returned to Riley Gastroenterology. Parents/guardians will be reminded by phone call and text message to complete and return mail the survey.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Eosinophilic Esophagitis, EoE, Riley
  • Age: 2 years - 18 years
  • Gender: All

Inclusion Criteria: 

  • Pediatric subjects aged 2-18 with an established EoE diagnosis based on esophageal symptoms and prior esophageal biopsies revealing ≥15 eosinophils per high-powered field in the squamous epithelium
  • Subjects must be followed in a Riley Hospital for Children Gastroenterology clinic, either virtually or in person

Updated on 04 Dec 2024. Study ID: PGI-IIR-CELLIE-KITS, 25300
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