Grants and Contracts Details
HUMAN CLINICAL TRIAL This is a prospective, multicenter, observational study designed to collect gastrointestinal related data in patients with CF. Eligible subjects will be consented and enrolled in the study at the Enrollment Visit. At the visit, the subject or parent/guardian will complete the patient reported outcome surveys (PROs) using their mobile device (e.g., smartphone or tablet). The PROs will consist of four questionnaires: Patient Assessment of Constipation-Symptoms (PAC-SYM), Patient Assessment of Gastrointestinal-Symptoms (PAGI-SYM), Patient Assessment of Constipation Quality of Life (PAC-QOL) and the disease-specific questionnaire. The diseasespecific questionnaire will include the Bristol Stool Scale and will collect information on presence of fecal incontinence, stool quality and stool frequency. At the Enrollment Visit, weight and height will be collected in addition to medical history and concomitant medication information. The subject or parent/guardian will complete the PROs outside-the-clinic setting per the Schedule of Events using their mobile device. Primary objective: Assess the feasibility of electronic PROs conducted outside-theclinic. Secondary Objectives: - Estimate the prevalence and variability of GI symptoms occurring in pediatric and adult patients with CF - Describe current management of GI symptoms in patients with CF - Gather information to guide and inform on the design of future algorithm-based approaches to treating GI symptoms in people with CF
|Effective start/end date||12/1/18 → 11/30/19|
- Seattle Childrens Research Institute: $20,488.00
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