Evaluation of Adherence and Outcomes in Children With Functional Constipation After Implementing a Constipation Action Plan
Phase: NA
Conditions: Constipation - Functional
Sponsor: Nemours Children's Clinic

COVER PAGE 
 
Study Title: Evaluation of adherence and outcomes in children with functional constipation  
after implementing a constipation action plan 
 
NCT: pending 
 
Date of Document: 18 October 2016 
 

Study Protocol Title 
Evaluation of adherence and outcomes in children with functional constipation after 
implementing a constipation action plan 
 
Principal Investigator, Research Team, and Study Site 
Principal investigator: Matthew D. Di Guglielmo, MD PhD  
Co-Investigator: Heidi E. Hagerott, DO 
Phone: 302.651.5928  
Fax:  302.651.5838 
Address:  1600 Rockland Rd. Wilmington, DE 19803 
Study site:  Nemours/A.I. DuPont Hospital for Children 
 
Study Title 
Evaluation of adherence and outcomes in children with functional constipation after 
implementing a constipation action plan 
 
Study Population 
Children are eligible to participate in the study if they are otherwise healthy children whose 
primary language is English with no conditions that would predispose them to develop 
constipation, between the ages of 3 and 8 years of age and meet the ROME IV criteria for 
functional constipation.  
 
Study Agent and Intervention Description 
Implementation of a Constipation action plan tool: a document describing step by step what 
needs to be done in response to the patient’s daily symptomatology of constipation.  
 
Primary Objective 
1. To assess compliance in pediatric patients with functional constipation that have been 
provided a constipation action plan plus educational information. 
Outcome measures: compliance 
Sticker reward chart review at 3 month visit in addition to constipation/adherence 
questionnaire at initial visit, 1 month telephone encounter and 3 month follow up 
visit.  
 
Secondary Objectives 
1. To assess improvement of constipation symptoms in pediatric patients with functional 
constipation that have been provided a constipation action plan and educational 
information 
Outcome measures:  symptoms 
Assess constipation symptoms by using the constipation/adherence questionnaire 
involving ROME IV Criteria at enrollment (with demographics), 1 month 
telephone encounter and 3 month follow up visit. 
 
2. To assess the perceived effectiveness of the constipation action plan from the viewpoint 
of the family 
Outcome measures:   perceived effectiveness of the constipation action plan  
           Assess the perceived effectiveness by an anonymous survey 

Study design/methodology 
This is a randomized controlled single blind study to measure compliance and outcomes in 
pediatric patients diagnosed with functional constipation. Participants will be recruited from the 
Division of Pediatric Gastroenterology and Nutrition at Nemours/A.I. duPont Hospital for 
Children who are being seen with a complaint of constipation. Children are eligible to participate 
in the study if they are otherwise healthy children whose primary language is English with no 
conditions that would predispose them to develop constipation, between the ages of 3 and 8 years 
old and meet the ROME IV criteria for functional constipation. We will obtain parental 
permission and assent from children older than 7 years of age from all participants. Each family 
will receive a randomized packet containing educational information (i.e. definitions, water and 
fiber intake, toilet sitting and medication information), rewards charts and stickers and half of the 
families will receive an additional constipation action plan tool. The treatment plan for each 
participant will be determined based on recommendations from the clinical guidelines for the 
Evaluation and Treatment of Functional Constipation Infants and Children as published by the 
North American Society for Pediatric Gastroenterology, Hepatology and Nutrition. The packets 
containing the additional constipation action plan tool will not be known to the investigator prior 
to assigning the packet to a family. At the first visit, the families will complete an initial paper 
questionnaire regarding symptomatology, adherence to the treatment plan and demographics. 
The questionnaires will not contain any patient identifiers and will be stored securely at 
Nemours. At 1 month, the co-investigator will call each family and administer a phone survey 
through REDcap regarding symptomatology and adherence to the treatment plan in the past 
month. At 3 months, the families will return for a follow up visit with their 3 month reward 
charts and complete a final paper survey regarding the child’s symptomatology and adherence to 
the treatment plan. The CO-I will upload the questionnaire responses onto REDcap based on the 
identification number. The families who were randomized into the group that received the 
constipation action plan tool will be mailed a survey regarding the utility of the constipation 
action plan and whether or not it was helpful in improving adherence to treatment and outcomes. 
Once received, the feedback survey will also be uploaded onto REDcap based on the 
identification number.  
 
Study Schedule 
Children will be recruited from November 2016 - October of 2017. Participants will remain in 
the study for a total of 3 months, or until the ‘3-month follow up appointment’ is completed, but 
no later than February 2018.  
 
Adverse Event Reporting 
All adverse events and serious adverse events in association with this study will be reported 
immediately to the IRB. An adverse event is defined as any unfavorable medical occurrence in a 
human subject, including any abnormal sign (abnormal physical exam or laboratory finding), 
symptom, or disease, temporally associated with the subject’s participation in the research, 
whether or not considered related to the subject’s participation in the research. The AE or SAE 
will be documented in the online secure database and the participant will have the opportunity to 
withdraw from the study if warranted, further follow up and monitoring with be scheduled as 
indicated based on the adverse event.  
 
 

Statistical Analysis Plan 
Descriptive statistics will be used to determine the distribution of key outcome and predictor 
variables. Means and standard deviations will be calculated to describe the distributions of 
continuous variables. Counts and proportions will be calculated to describe the distributions of 
categorical variables. The effectiveness of the constipation action plan tool will be assessed by 
comparing the parent/survey-responder’s reported adherence of the child to the constipation 
treatment in the intervention and control groups, at each follow-up survey, using multivariable 
logistic regression model. The change in effectiveness of the constipation action plan tool will be 
assessed by comparing the intervention and control groups across waves of the follow-up 
surveys, using multivariable mix-effects logistic regression model. Differences in demographic 
characteristics between the groups will be adjusted for during analysis. The association between 
compliance and constipation outcomes will be examined likewise.  
 
Informed Consent Process 
Informed consent will be taken after the patient is seen in the outpatient setting and has agreed to 
participate in the study. The CO-I will discuss the project details with the family and allow them 
to return on a subsequent visit to sign the consent and fill out the forms if they feel they require 
more time to think about participation. The families will be allowed to ask questions regarding 
the project and all questions will be answered prior to signing the consent form. The families will 
meet with the CO-I; all information will be provided to the families including a detailed 
description of the study and an explanation of how this will contribute to the scientific 
community. Assent will be obtained from all children 7 years of age and above. We will follow 
the families at 1 month and at 3 months to complete questionnaires and discuss their continued 
participation in the study. If the families decide they no longer wish to participate in the study 
they will be withdrawn. Translations will be submitted to the IRB for review and approval before 
enrolling non-English speaking participants. 
 
Privacy and confidentiality 
Each family will be seen in a private room for the visit encounters. In addition, the follow up 
surveys are completed via private telephone encounters and follow up interviews in private 
rooms. The CO-I will organize the list of participants and subsequent study identification 
numbers (as indicated on each packet they will receive) on password protected computer files 
(excel spreadsheet) on the Nemours server. The excel spreadsheet will be the only document 
containing PHI. All printed questionnaires are void of PHI and will contain only a participant 
(ID) number. The CO-I will upload the questionnaires to a secure website (REDcap) using the 
appropriate participant ID. 

 
Select patients from the 
outpatient GI clinic who meet 
study eligibility
Obtain parental permission 
and child assent
Obtain demographic 
information and initial 
constipation/adherence 
questionnaire
Randomization
Intervention group
1 month phone 
encounter and 
questionnaire 
3 month 
follow up visit 
and 
questionnaire
mail a 
feedback 
survey  
regarding 
intervention
statistical 
analysis/study 
complete
Control group
1 month phone 
encounter and 
questionnaire 
3 month 
follow up visit 
and 
questionnaire
statistical 
analysis/study 
complete