Adherence and Outcomes in Functional Constipation With a Constipation Action Plan
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Adherence, Medication
- Functional Constipation
- Pediatric ALL
- Survey, Family Life
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 4 years and 8 years
- Gender
- Both males and females
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 u...
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.
Tracking Information
- NCT #
- NCT04614935
- Collaborators
- Not Provided
- Investigators
- Not Provided