Adherence and Outcomes in Functional Constipation With a Constipation Action Plan

The University of Alabama at Birmingham

Status: Completed

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

Treatments: Behavioral: Action Plan

Study type: Interventional

Funder types: Other

Identifiers

NCT04614935

IRB-300005480

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 4 to 8 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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38 participants in 2 patient groups

Standard of Care

No Intervention group

Description:

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.

Action Plan

Experimental group

Description:

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.

Treatment:

Behavioral: Action Plan