Adherence and Outcomes in Functional Constipation With a Constipation Action Plan
Primary Purpose
Adherence, Medication, Functional Constipation, Pediatric ALL
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Action Plan
Sponsored by
About this trial
This is an interventional treatment trial for Adherence, Medication
Eligibility Criteria
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
Sites / Locations
- UAB/COA
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard of Care
Action Plan
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT04614935
First Posted
October 28, 2020
Last Updated
April 14, 2022
Sponsor
University of Alabama at Birmingham
1. Study Identification
Unique Protocol Identification Number
NCT04614935
Brief Title
Adherence and Outcomes in Functional Constipation With a Constipation Action Plan
Official Title
Adherence and Outcomes in Functional Constipation With a Constipation Action Plan
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
March 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adherence, Medication, Functional Constipation, Pediatric ALL, Survey, Family Life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
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.
Arm Title
Action Plan
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Action Plan
Other Intervention Name(s)
Adherence Log
Intervention Description
See arm description.
Primary Outcome Measure Information:
Title
Medication and behavioral modification adherence
Description
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).
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Quality of Life survey results
Description
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.
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
UAB/COA
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
10201721
Citation
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.
Results Reference
background
PubMed Identifier
16678566
Citation
Rasquin A, Di Lorenzo C, Forbes D, Guiraldes E, Hyams JS, Staiano A, Walker LS. Childhood functional gastrointestinal disorders: child/adolescent. Gastroenterology. 2006 Apr;130(5):1527-37. doi: 10.1053/j.gastro.2005.08.063.
Results Reference
background
PubMed Identifier
29754864
Citation
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.
Results Reference
background
PubMed Identifier
24345842
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.
Results Reference
background
PubMed Identifier
25148757
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.
Results Reference
background
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Adherence and Outcomes in Functional Constipation With a Constipation Action Plan
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