Adherence and Outcomes in Functional Constipation With a Constipation Action Plan

Pediatric ALL Clinical Trial

Official title:

Adherence and Outcomes in Functional Constipation With a Constipation Action Plan

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04614935
• Other study ID #: IRB-300005480
• Status: Completed
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: March 1, 2022

Study information

• Verified date: April 2022
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: March 1, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 8 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Action Plan
See arm description.

Locations

Country	Name	City	State
United States	UAB/COA	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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.

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Quality of Life survey results	Parent report of child constipation symptoms using validated Pediatric Quality of Life (PedsQL) survey for functional constipation in the past month, using the Likert scale responses, with raw scores transformed to a 0 to 100 scale, with 0 being severe impairment and 100 being no impairment. This survey will be given on initial visit and repeated at 2 month and 4 month follow up visits.	4 months