Clinical trial NCT04614935: Adherence and Outcomes in Functional Constipation With a Constipation Action Plan
Official title: Adherence and Outcomes in Functional Constipation With a Constipation Action Plan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adherence, Medication
Functional Constipation
Pediatric ALL
Survey, Family Life
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2020-11-04
Enrollment: 38
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We will be assessing for improvement in reported symptoms as well as reported quality of life in pediatric patients with functional constipation using a constipation action plan and an adherence log.

Detailed description: Functional Constipation is one of the most common chief complaints for both the general pediatrician and the pediatric gastroenterologist. Treatment for this disorder is multifactorial, and usually involves different medications combined with behavioral techniques, depending on the severity of the underlying constipation. Studies have shown that medication compliance is one of the strongest predictors of successful treatment, but maintaining good medication adherence at home is uncommon for a variety of reasons. In this study, the investigators are aiming to improve home medication adherence for functional constipation to improve treatment outcomes. The investigators will be administering surveys for all enrolled participants to determine the child's and family's overall quality of life related to functional constipation. For the treatment group, the investigators will be providing tools to help with medication adherence. This will include a daily log to determine symptom severity, along with an "action plan" with instructions for how to adjust medicines, if necessary, depending on symptoms. By empowering families with this knowledge and medication roadmap, the investigators hypothesize that there will be overall symptomatic improvement in functional constipation, along with improved quality of life for both the patient and their family. The investigators will measure adherence (by reviewing symptom log and action plan at 2-month and 4-month follow up appointments.) with the treatment group. The investigators will be measuring overall quality of life and symptom improvement using a validated pediatric constipation quality of life survey (PedsQL GI) with both the treatment group and the control group at follow up appointments.

Eligibility criteria: Inclusion Criteria:

* Have been potty-trained for stool at some point
* Chief complaint constipation or encopresis
* Meets Rome IV criteria for functional constipation

Exclusion Criteria:

* Preexisting diagnoses of autism, cerebral palsy, developmental delay, and/or thyroid disease
* 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

Primary outcomes:
measure: Medication and behavioral modification adherence
timeFrame: 4 months
Secondary outcomes:
measure: Quality of Life survey results
timeFrame: 4 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB/COA
state: Alabama
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.