Adherence and Outcomes in Functional Constipation With a Constipation Action Plan

NCT04614935 | Completed

• 1 other identifier: IRB-300005480
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Medication and behavioral modification adherence

  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).

  4 months

Secondary Outcomes (1)

• Quality of Life survey results

  4 months

Study Arms (2)

Standard of Care

NO INTERVENTION

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

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.

Behavioral: Action Plan

Interventions

Action Plan BEHAVIORAL

See arm description.

Also known as: Adherence Log

Action Plan

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

UAB/COA

Birmingham, Alabama, 35233, United States

Location

Related Publications (5)

• Felt B, Wise CG, Olson A, Kochhar P, Marcus S, Coran A. Guideline for the management of pediatric idiopathic constipation and soiling. Multidisciplinary team from the University of Michigan Medical Center in Ann Arbor. Arch Pediatr Adolesc Med. 1999 Apr;153(4):380-5. doi: 10.1001/archpedi.153.4.380.

  PMID: 10201721 BACKGROUND

• Hyams, Jeffrey S., et al. "Childhood Functional Gastrointestinal Disorders: Child/Adolescent." Gastroenterology, vol. 150, no. 6, 2016, doi:10.1053/j.gastro.2016.02.015.

  BACKGROUND

• Koppen IJN, van Wassenaer EA, Barendsen RW, Brand PL, Benninga MA. Adherence to Polyethylene Glycol Treatment in Children with Functional Constipation Is Associated with Parental Illness Perceptions, Satisfaction with Treatment, and Perceived Treatment Convenience. J Pediatr. 2018 Aug;199:132-139.e1. doi: 10.1016/j.jpeds.2018.03.066. Epub 2018 May 10.

  PMID: 29754864 BACKGROUND

• Steiner SA, Torres MR, Penna FJ, Gazzinelli BF, Corradi CG, Costa AS, Ribeiro IG, de Andrade EG, do Carmo Barros de Melo M. Chronic functional constipation in children: adherence and factors associated with drug treatment. J Pediatr Gastroenterol Nutr. 2014 May;58(5):598-602. doi: 10.1097/MPG.0000000000000255.

  PMID: 24345842 BACKGROUND

• Varni JW, Bendo CB, Denham J, Shulman RJ, Self MM, Neigut DA, Nurko S, Patel AS, Franciosi JP, Saps M, Yeckes A, Langseder A, Saeed S, Pohl JF. PedsQL Gastrointestinal Symptoms Scales and Gastrointestinal Worry Scales in pediatric patients with functional and organic gastrointestinal diseases in comparison to healthy controls. Qual Life Res. 2015 Feb;24(2):363-78. doi: 10.1007/s11136-014-0781-x. Epub 2014 Aug 23.

  PMID: 25148757 BACKGROUND

MeSH Terms

Conditions

Medication Adherence; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow, Pediatric Gastroenterology

Study Record Dates

• First Submitted: October 28, 2020
• First Posted: November 4, 2020
• Study Start: November 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: March 1, 2022
• Last Updated: April 15, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)