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NCT05437523: USCAP
Clinical Implementation of a Pictographic Constipation Action Plan for Children With Functional Constipation
NA trial testing Constipation Action Plan in Functional Constipation in 150 participants. Completed in 1 April 2022.
1 December 2021
Quick facts
| Lead sponsor | Walter Reed National Military Medical Center |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 150 |
| Start date | 1 August 2020 |
| Primary completion | 1 December 2021 |
| Estimated completion | 1 April 2022 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Constipation Action Plan
- Standard of care without constipation action plan
Conditions studied
- Functional Constipation — all drugs for Functional Constipation →
Sponsor
Walter Reed National Military Medical Center
Who can join
Adults 4 to 25, any sex, with Functional Constipation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05437523
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Constipation Action Plan
Trials testing the same drug.
- NCT03821532 — Adherence/Outcomes After Use of Constipation Action Plan · NA · completed
Other recruiting trials for Functional Constipation
Currently open trials in the same condition.
- NCT07148583 — BioAmicus Complete for Functional Gastrointestinal Symptoms in Infants Aged 0 to 24 Months · NA · recruiting
- NCT07091084 — A Study of Herbal Supplements in Cancer Survivors With Constipation · NA · recruiting
- NCT06534996 — A Single Arm Pilot Study of the Chinese Herbal Medicine Formula (SCD-2101) for the Functional Constipation in the Elderl · NA · recruiting
- NCT04918329 — Functional Digestive Disorders Observatory · recruiting
- NCT04547816 — Efficacy of Conservative Treatment of Functional Defecatory Disorders in Females With Pelvic Organ Prolapse · Phase 3 · recruiting
Other Walter Reed National Military Medical Center trials
Trials by the same sponsor.
- NCT07151417 — Use of Corticosteroid in Intraopertive Injections in Total Knee Replacement Surgery. · Phase 2, PHASE3 · not yet recruiting
- NCT06636136 — Transtibial Osseointegration · NA · recruiting
- NCT06808347 — Difference in Serum Estrogen Level Based on Methods of Vaginal Estrogen Application (fingertip Vs Applicator Use) in Pos · Phase 4 · not yet recruiting
- NCT06731348 — Patient Satisfaction With Opioid Restriction After Urogynecologic Surgery · Phase 4 · enrolling by invitation
- NCT06729151 — Effect of Intradetrusor onabotulinumtoxinA Injection Versus Conservative Management on Female Sexual Function in Patient · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05437523 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Walter Reed National Military Medical Center
- Last refreshed: 29 June 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05437523.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing