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Clinical Implementation of a Pictographic Constipation Action Plan for Children With Functional Constipation

NCT05437523 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2022-06-29

No results posted yet for this 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.

Conditions

  • Functional Constipation

Interventions

OTHER

Constipation Action Plan

The author team previously developed and assessed this constipation action plan using the universal precautions approach to produce a tool which could optimize knowledge transfer from clinicians to patients, and support stepwise home self-management of functional constipation. The Uniformed Services Constipation Action Plan can be freely downloaded at the following web link: https://wrnmmc.libguides.com/pediatrics/USAP

OTHER

Standard of care without constipation action plan

Standard of care without constipation action plan

Sponsors & Collaborators

  • Walter Reed National Military Medical Center

    lead FED

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-01
Primary Completion
2021-12-01
Completion
2022-04-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05437523 on ClinicalTrials.gov