Clinical trial NCT03821532: Adherence/Outcomes After Use of Constipation Action Plan
Official title: Evaluation of Adherence and Outcomes in Children With Functional Constipation After Implementing a Constipation Action Plan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Constipation - Functional
Keywords: Action Plan
Adherence
Pediatrics
Lead sponsor: Nemours Children's Clinic
Sponsor class: OTHER
First posted: 2019-01-29
Enrollment: 25
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Control group (standard of care) compared to Intervention group (standard of care plus constipation action plan)
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Compliance Questionnaire
timeFrame: At screening
measure: Compliance Questionnaire
timeFrame: 1 Month
measure: Compliance Questionnaire
timeFrame: 3 Month
measure: Compliance Reward Chart
timeFrame: 3 Month
Secondary outcomes:
measure: Symptoms
timeFrame: At screening
measure: Symptoms
timeFrame: 1 Month
measure: Symptoms
timeFrame: 3 Month
measure: Perceived effectiveness
timeFrame: 1 month telephone encounter
measure: Perceived effectiveness
timeFrame: 3 month follow up visit
measure: Caregiver Literacy
timeFrame: 0 months
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: Alfred I. duPont Hospital for Children
state: Delaware
Study officials:
affiliation: Nemours
name: Matthew Di Guglielmo, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Luersen K, Davis SA, Kaplan SG, Abel TD, Winchester WW, Feldman SR. Sticker charts: a method for improving adherence to treatment of chronic diseases in children. Pediatr Dermatol. 2012 Jul-Aug;29(4):403-8. doi: 10.1111/j.1525-1470.2012.01741.x. Epub 2012 Apr 4.
citation: Ismail N, Ratchford I, Proudfoot C, Gibbs J. Impact of a nurse-led clinic for chronic constipation in children. J Child Health Care. 2011 Sep;15(3):221-9. doi: 10.1177/1367493511406568. Epub 2011 Aug 9.
citation: Arozullah AM, Yarnold PR, Bennett CL, Soltysik RC, Wolf MS, Ferreira RM, Lee SY, Costello S, Shakir A, Denwood C, Bryant FB, Davis T. Development and validation of a short-form, rapid estimate of adult literacy in medicine. Med Care. 2007 Nov;45(11):1026-33. doi: 10.1097/MLR.0b013e3180616c1b.