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NCT05437523 · ClinicalTrials.gov registry record · NA
Clinical Implementation of a Pictographic Constipation Action Plan for Children With Functional Constipation
A NA study, sponsored by Walter Reed National Military Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 150
- Enrollment target
NCT05437523: Completed NA study, sponsored by Walter Reed National Military Medical Center.
NCT05437523 is a NA study that has completed, run by Walter Reed National Military Medical Center. The registered enrollment target is 150 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05437523, a NA study, has completed, sponsored by Walter Reed National Military Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 150 participants
- Enrollment target
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.
Primary Outcome
The measure of implementation effectiveness was clinical: whether the subject met the ROME IV criteria for functional constipation based on the Rome IV Diagnostic Questionnaire for Pediatric Gastrointestinal Disorders for Children and Adolescents (ROME IV Pediatric Diagnostic Questionnaire). Scoring instructions for Functional Constipation: Two or more of the following: (C 1) Two or fewer stools per week, OR (C3) painful stool\] OR (C4) Passage of very large stools, OR (C5) Stool retention "o
Interventions
- OTHER Constipation Action Plan
- OTHER Standard of care without constipation action plan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2020-08-01 |
| Est. Completion | 2022-04-01 |
| Phase | NA |
What the finished NCT05437523 record still lists
NCT05437523 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which Constipation Action Plan is the first listed.
NCT05437523 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05437523 about?
NCT05437523 is a clinical study titled "Clinical Implementation of a Pictographic Constipation Action Plan for Children With Functional Constipation". 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 ...
What is the current status of trial NCT05437523?
This trial is currently completed. It is a NA study. The enrollment target is 150 participants. The study started on 2020-08-01. Estimated completion is 2022-04-01.
What interventions are being tested in trial NCT05437523?
The interventions under investigation include: Constipation Action Plan (OTHER), Standard of care without constipation action plan (OTHER).
Who is sponsoring clinical trial NCT05437523?
This trial is sponsored by Walter Reed National Military Medical Center, which has 48 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05437523's enrollment target sits among peer trials
150 661st of 2000 higher than 1,299 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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