Adherence/Outcomes After Use of Constipation Action Plan

January 29, 2019 updated by: Matthew Di Guglielmo, Nemours Children's Clinic

Evaluation of Adherence and Outcomes in Children With Functional Constipation After Implementing a Constipation Action Plan

Adherence to recommendations for treatment of chronic constipation in pediatric population is often poor. This study is attempting to improve adherence, and outcomes, by implementing a trial of a constipation action plan plus standard of care, compared to standard of care alone, in an outpatient pediatric population.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Functional Constipation is a common childhood problem. The goal of this study is to evaluate if a constipation action plan had any impact on improved adherence in management. 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 if they meet the ROME IV criteria for functional constipation. The primary objective is to assess compliance in pediatric patients with functional constipation that have been provided a constipation action plan plus educational information. The secondary objectives are to assess improvement of constipation symptoms in pediatric patients with functional constipation that have been provided a constipation action plan and educational information and to assess the perceived effectiveness of the constipation action plan from the viewpoint of the family. The proposed study hypothesizes that patients diagnosed with functional constipation will have improved adherence to medication treatment plan, to fiber intake, and to toilet sit time and have improved constipation symptoms overall when provided with both a constipation action plan and educational information regarding dietary changes, toilet sit time, and medications as compared to education information alone.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Delaware
      • Wilmington, Delaware, United States, 19803
        • Alfred I. DuPont Hospital for Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 8 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy
  • History of functional constipation
  • English as primary language

Exclusion Criteria:

  • History of medical conditions pre-disposing to constipation
  • English as a second language
  • Chronic gastrointestinal disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Each family will receive a randomized packet containing educational information, rewards charts and an adult literacy test. The treatment plan 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. At the first visit, the parent(s) will complete an adult literacy test and an initial paper questionnaire regarding symptoms, adherence to the treatment plan and demographics. At 1 month, the primary investigator will call each family and administer a phone survey regarding symptoms 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 symptoms and adherence to the treatment plan.
Experimental: Experimental group
Each family will receive a randomized packet containing educational information, rewards charts, an adult literacy test and a constipation action plan tool. The treatment plan 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. At the first visit, the parent(s) will complete an adult literacy test and an initial paper questionnaire regarding symptoms, adherence to the treatment plan and demographics. At 1 month, the primary investigator will call each family and administer a phone survey regarding symptoms 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 symptoms, adherence to the treatment plan, and action plan utility.
Other: Constipation Action Plan
Action plan, adapted from Autism Speaks Network, demonstrating Red, Yellow, and Green levels of symptoms with corresponding steps for treatment or action by parent/guardian, tailored by care provider to the child's condition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compliance Questionnaire
Time Frame: At screening
Evaluate compliance using the constipation/adherence questionnaire. The questionnaire has 3 questions addressing the total number of days missed per week taking the prescribed medications, toilet sit times and dietary intake
At screening
Compliance Questionnaire
Time Frame: 1 Month
Compliance will be evaluated by reviewing the sticker reward chart at the 3 month visit and calculating the number of days the child missed medication dose, did not sit on the toilet as instructed and how many days were missed of adequate fiber intake. Further evaluate compliance using the constipation/adherence questionnaire. The questionnaire has 3 questions addressing the total number of days missed per week taking the prescribed medications, toilet sit times and dietary intake
1 Month
Compliance Questionnaire
Time Frame: 3 Month
Compliance will be evaluated by reviewing the sticker reward chart at the 3 month visit and calculating the number of days the child missed medication dose, did not sit on the toilet as instructed and how many days were missed of adequate fiber intake. Further evaluate compliance using the constipation/adherence questionnaire. The questionnaire has 3 questions addressing the total number of days missed per week taking the prescribed medications, toilet sit times and dietary intake
3 Month
Compliance Reward Chart
Time Frame: 3 Month
Compliance will be evaluated by reviewing the sticker reward chart at the 3 month visit and calculating the number of days the child missed medication dose, did not sit on the toilet as instructed and how many days were missed of adequate fiber intake.
3 Month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptoms
Time Frame: At screening
Number of participants with positive constipation symptoms using ROME IV Criteria
At screening
Symptoms
Time Frame: 1 Month
Number of participants with positive constipation symptoms using ROME IV Criteria
1 Month
Symptoms
Time Frame: 3 Month
Number of participants with positive constipation symptoms using ROME IV Criteria
3 Month
Perceived effectiveness
Time Frame: 1 month telephone encounter
Anonymous survey addresses questions regarding the number of days the child was in each zone of the constipation action plan and whether or not the plan helped the family better manage the child's symptoms, decreased calls to the physician and whether or not it was easy to use.
1 month telephone encounter
Perceived effectiveness
Time Frame: 3 month follow up visit
Anonymous survey addresses questions regarding the number of days the child was in each zone of the constipation action plan and whether or not the plan helped the family better manage the child's symptoms, decreased calls to the physician and whether or not it was easy to use.
3 month follow up visit
Caregiver Literacy
Time Frame: 0 months
Assess literacy level for caregivers by administering the Short-Form Rapid Assessment of Adult Literacy in Medicine. Final score of 0, 1-3, 4-6, or 7 determines grade reading level (3rd grade or less, 4th to 6th, 7th to 8th, 9th grade and higher). There is no better or worse outcome, just stratification of literacy (medical) is determined.
0 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nemours Children's Clinic

Investigators

  • Principal Investigator: Matthew Di Guglielmo, MD PhD, Nemours

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 13, 2016

Primary Completion (Actual)

February 1, 2018

Study Completion (Actual)

May 1, 2018

Study Registration Dates

First Submitted

December 15, 2018

First Submitted That Met QC Criteria

January 27, 2019

First Posted (Actual)

January 29, 2019

Study Record Updates

Last Update Posted (Actual)

January 31, 2019

Last Update Submitted That Met QC Criteria

January 29, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 947325

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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