Clinical Implementation of a Pictographic Constipation Action Plan for Children With Functional Constipation - Trial NCT05437523
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Study Focus
Sponsor & Location
Walter Reed National Military Medical Center
Timeline & Enrollment
N/A
Aug 01, 2020
Apr 01, 2022
Primary Outcome
Clinical outcomes- ROME IV Pediatric Diagnostic Questionnaire to diagnose Functional Constipation- Start of Study,Clinical outcomes- ROME IV Pediatric Diagnostic Questionnaire to diagnose Functional Constipation- End of Study,Patient-related outcomes-PedsQL™ Gastrointestinal Symptoms Version 3.0 (PedsGIQL),Patient-related outcomes-PedsQL™ Gastrointestinal Symptoms Version 3.0 (PedsGIQL),Health confidence- Health Confidence Score to measure self-efficacy- Start of Study,Health confidence- Health Confidence Score to measure self-efficacy- End of Study
Summary
Constipation is a common disorder that globally affects 0.7% to 29.6% of children. The
 majority of these children receive the diagnosis of functional constipation. Functional
 Constipation can be challenging to diagnose and treat. The ROME IV criteria provides
 structure in the approach to Functional Constipation by standardizing diagnosis criteria.
 Functional Constipation should be suspected when a child has at least two symptoms per week
 for the last month consisting of: two or fewer defecations in the toilet per week, greater
 than or equal to 1 episode of fecal incontinence per week, history of retentive posturing or
 excessive volitional stool retention, history of painful or hard bowel movements, presence of
 a large fecal mass in the rectum, or history of large diameter stools that can obstruct the
 toilet.
 
 Written action plans and similar self-management tools have been associated with improved
 clinical and patient-reported outcomes for several pediatric chronic disease processes
 including anaphylaxis, asthma, and atopic dermatitis. These tools have been shown to improve
 patient/caregiver confidence in disease self-management at home, to increase adherence to
 pharmacotherapy regimens, and ultimately to enhance patient-centered outcomes. The impact of
 a Constipation Action Plan on Functional Constipation clinical and patient-related outcomes
 has not been investigated. The aim of this project was to implement and to evaluate the
 effectiveness of the Uniformed Services Constipation Action Plan in the management of
 children with Functional Constipation in a pediatric gastroenterology clinic.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT05437523
Non-Device Trial