Adherence and Outcomes in Functional Constipation With a Constipation Action Plan
NCT ID: NCT04614935
Last Updated: 2022-04-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
38 participants
INTERVENTIONAL
2020-11-01
2022-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard of Care
Pediatric patients with functional constipation who are treated with medications and/or behavioral therapies as they would be if they were not enrolled in the study. In addition to standard of care treatment, these families will fill out a brief quality of life survey.
No interventions assigned to this group
Action Plan
Pediatric patients with functional constipation who are treated with standard of care medications and/or behavioral therapies and are also provided with a medication adherence log along with a constipation action plan. These families will also fill out a brief quality of life survey.
Action Plan
See arm description.
Interventions
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Action Plan
See arm description.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Chief complaint constipation or encopresis
* Meets Rome IV criteria for functional constipation
Exclusion Criteria
* Prior gastrointestinal surgery
* Presence of "red flag" symptoms for organic etiology:
* Passage of meconium \>48 hours after birth in a term newborn
* Family history of Hirschsprung's Disease
* "Ribbon" stools
* Blood in stools (in absence of anal fissure)
* Coexisting diagnosis of malnutrition, bilious vomiting, abnormal anal positioning, absent anal reflex, decreased lower extremity strength/tone, sacral dimple, and/or tuft of hair on spine
4 Years
8 Years
ALL
Yes
Sponsors
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University of Alabama at Birmingham
OTHER
Responsible Party
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Carter D. Wallace
Fellow, Pediatric Gastroenterology
Locations
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UAB/COA
Birmingham, Alabama, United States
Countries
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References
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Felt B, Wise CG, Olson A, Kochhar P, Marcus S, Coran A. Guideline for the management of pediatric idiopathic constipation and soiling. Multidisciplinary team from the University of Michigan Medical Center in Ann Arbor. Arch Pediatr Adolesc Med. 1999 Apr;153(4):380-5. doi: 10.1001/archpedi.153.4.380.
Hyams, Jeffrey S., et al. "Childhood Functional Gastrointestinal Disorders: Child/Adolescent." Gastroenterology, vol. 150, no. 6, 2016, doi:10.1053/j.gastro.2016.02.015.
Koppen IJN, van Wassenaer EA, Barendsen RW, Brand PL, Benninga MA. Adherence to Polyethylene Glycol Treatment in Children with Functional Constipation Is Associated with Parental Illness Perceptions, Satisfaction with Treatment, and Perceived Treatment Convenience. J Pediatr. 2018 Aug;199:132-139.e1. doi: 10.1016/j.jpeds.2018.03.066. Epub 2018 May 10.
Steiner SA, Torres MR, Penna FJ, Gazzinelli BF, Corradi CG, Costa AS, Ribeiro IG, de Andrade EG, do Carmo Barros de Melo M. Chronic functional constipation in children: adherence and factors associated with drug treatment. J Pediatr Gastroenterol Nutr. 2014 May;58(5):598-602. doi: 10.1097/MPG.0000000000000255.
Varni JW, Bendo CB, Denham J, Shulman RJ, Self MM, Neigut DA, Nurko S, Patel AS, Franciosi JP, Saps M, Yeckes A, Langseder A, Saeed S, Pohl JF. PedsQL Gastrointestinal Symptoms Scales and Gastrointestinal Worry Scales in pediatric patients with functional and organic gastrointestinal diseases in comparison to healthy controls. Qual Life Res. 2015 Feb;24(2):363-78. doi: 10.1007/s11136-014-0781-x. Epub 2014 Aug 23.
Other Identifiers
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IRB-300005480
Identifier Type: -
Identifier Source: org_study_id
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