Ignite Creation Date:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2025-12-25 @ 7:49 PM
Study NCT ID:
NCT04614935
Status:
COMPLETED
Last Update Posted:
2022-04-15
First Post:
2020-10-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Adherence and Outcomes in Functional Constipation With a Constipation Action Plan
Sponsor:
University of Alabama at Birmingham
Organization:
Study Overview
Official Title:
Adherence and Outcomes in Functional Constipation With a Constipation Action Plan
Status:
COMPLETED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: