Adherence/Outcomes After Use of Constipation Action Plan



Status:Completed
Conditions:Constipation
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:4 - 8
Updated:2/2/2019
Start Date:September 13, 2016
End Date:May 1, 2018

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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.

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.

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
We found this trial at
1
site
1600 Rockland Road
Wilmington, Delaware 19803
(302) 651-4200
Alfred I. duPont Hospital for Children Nemours began more than 70 years ago with the...
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mi
from
Wilmington, DE
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