Skip to main content
OpenTrials
Completed

NCT Number: NCT03821532

Adherence/Outcomes After Use of 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Constipation - Functional

Age range

4 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alfred I. duPont Hospital for Children

Wilmington, Delaware, 19803, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Constipation Action Plan

Other

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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.

Secondary outcomes

  1. Symptoms

    Time frame: At screening

    Number of participants with positive constipation symptoms using ROME IV Criteria

  2. Symptoms

    Time frame: 1 Month

    Number of participants with positive constipation symptoms using ROME IV Criteria

  3. Symptoms

    Time frame: 3 Month

    Number of participants with positive constipation symptoms using ROME IV Criteria

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Nemours Children's Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jan 29, 2019
Registry last updated
Jan 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.