Adherence & Outcomes in Functional Constipation With a Constipation Action

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04614935
Study type	Interventional
Source	University of Alabama at Birmingham
Contact
Status	Completed
Phase	N/A
Start date	November 1, 2020
Completion date	March 1, 2022

View Details

See also
Status	Clinical Trial	Phase
Enrolling by invitation	`NCT05818644` - Hepatic Artery Stenosis and Thrombosis After Liver Transplantation in Children
Not yet recruiting	`NCT06018324` - CloudCare in the Treatment of Type 1 Diabetes in Pediatrics
Not yet recruiting	`NCT04523623` - Pain Control Differences Between Oxycodone and Ibuprofen in Children With Isolated Forearm Injuries	N/A
Completed	`NCT02930850` - Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation	N/A
Completed	`NCT03385681` - Pediatric Pain Management - an Intervention Study	N/A
Completed	`NCT00229671` - Medication Errors and Adverse Drug Events (ADEs) in Ambulatory Pediatrics	N/A
Completed	`NCT04465370` - Pediatric Cardiac Output Monitoring Observational Study
Recruiting	`NCT04100070` - Intensive Versus Standard One Year Monitoring on Glycaemic Control After Initiating CSII in Children With DT1. DEEP Study	N/A
Not yet recruiting	`NCT06035757` - The Occurrence of Emergence Agitation in Pediatric Strabismus Surgery	Phase 4
Completed	`NCT03369847` - Inhaled Steroids for Pediatric Asthma at Pediatric Emergency Medicine Discharge	Phase 4
Completed	`NCT05474170` - Impact of 2 Resuscitation Sequences on Management of Simulated Pediatric Cardiac Arrest	N/A
Recruiting	`NCT05230004` - Innovative Prosthetic Systems for Pediatric Limb Loss to Accommodate Growth	N/A
Completed	`NCT05818215` - Impact of the Qatar 2022 FIFA World Cup on PED Use and Misuse Patterns
Completed	`NCT05731401` - Expressed Beliefs About the Cause of Pain in a Paediatric Population
Completed	`NCT06376188` - Improving Breaking Bad News in Pediatrics by Simulated Communication	N/A
Completed	`NCT04589910` - Measuring Thickness of the Normal Diaphragm in Children Via Ultrasound.	N/A
Recruiting	`NCT04252508` - Impact of a Double-reading Animated Film (Child, Parents) in Preoperative on the Anxiety of Children Upon Arrival at the Operating Room	N/A
Completed	`NCT04655378` - Validation of the IgA1 Detection Method With Gradient Glycosylation by Mass Spectrometry as a Potential Marker of Renal Involvement in Pediatric Rheumatoid Purpura
Completed	`NCT04610918` - Comparing Body Composition Assessment Methods
Completed	`NCT03964259` - Reduced IV Fluids to Improve Clearance of HDMTX in Children w/Lymphoma or Acute Lymphoblastic Leukemia	Phase 1

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Adherence and Outcomes in Functional Constipation With a Constipation Action Plan

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms