Adherence and Outcomes in Functional Constipation With a Constipation Action Plan

Not Applicable

Completed

• Conditions: Survey, Family Life; Pediatric ALL; Adherence, Medication; Functional Constipation
• Interventions: Behavioral: Action Plan

• Registration Number: NCT04614935
• Lead Sponsor: University of Alabama at Birmingham

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-10-28
• Study First Submitted QC: 2020-10-28
• Study Start: 2020-11-01
• Study First Posted: 2020-11-04
• Primary Completion: 2021-12-31
• Study Completion: 2022-03-01
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-14
• Last Update Posted: 2022-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Action Plan	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.

Primary Outcome Measures

Name	Time	Method
Medication and behavioral modification adherence	4 months	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).

Secondary Outcome Measures

Name	Time	Method
Quality of Life survey results	4 months	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.

Trial Locations

Locations (1)

UAB/COA; 🇺🇸 Birmingham, Alabama, United States