Adherence and Outcomes in Functional Constipation With a Constipation Action Plan

Study Overview
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Brief Summary
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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
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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.

Official Title
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Adherence and Outcomes in Functional Constipation With a Constipation Action Plan

Conditions
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Adherence, Medication, Functional Constipation, Pediatric ALL, Survey, Family Life

Intervention / Treatment
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* Behavioral: Action Plan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of Care<br>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. | |
| Experimental: Action Plan<br>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. | Behavioral: Action Plan<br>* See arm description.<br>* Other names: Adherence Log;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication and behavioral modification adherence | Calendar where families place a colored sticker (green, yellow, or red, depending on how symptoms correlate to the constipation action plan), measured as a ratio of total number of days logged/total number of days possible to log. Adherence log will be reviewed at each follow appointment (2 month and 4 month). | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life survey results | Parent report of child constipation symptoms using validated Pediatric Quality of Life (PedsQL) survey for functional constipation in the past month, using the Likert scale responses, with raw scores transformed to a 0 to 100 scale, with 0 being severe impairment and 100 being no impairment. This survey will be given on initial visit and repeated at 2 month and 4 month follow up visits. | 4 months |