Adherence/Outcomes After Use of Constipation Action Plan

Not Applicable

Completed

• Conditions: Constipation - Functional
• Interventions: Other: Constipation Action Plan

• Registration Number: NCT03821532
• Lead Sponsor: Nemours Children's Clinic

Brief Summary

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.

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 Timeline

• Study Start: 2016-09-13
• Primary Completion: 2018-02-01
• Study Completion: 2018-05-01
• Study First Submitted: 2018-12-15
• Status Verified: 2019-01
• Study First Submitted QC: 2019-01-27
• Study First Posted: 2019-01-29
• Last Update Submitted: 2019-01-29
• Last Update Posted: 2019-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	Constipation Action Plan	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.

Primary Outcome Measures

Name	Time	Method
Compliance Questionnaire	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
Compliance Reward Chart	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 Outcome Measures

Name	Time	Method
Perceived effectiveness	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.
Caregiver Literacy	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.
Symptoms	3 Month	Number of participants with positive constipation symptoms using ROME IV Criteria

Trial Locations

Locations (1)

Alfred I. duPont Hospital for Children; 🇺🇸 Wilmington, Delaware, United States