Grants and Contracts Details
Description
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
Status | Finished |
---|---|
Effective start/end date | 12/1/18 → 11/30/19 |
Funding
- Seattle Childrens Research Institute: $20,488.00
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