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Adherence/Outcomes After Use of Constipation Action Plan

NCT ID: NCT03821532

Last Updated: 2019-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-13

Study Completion Date

2018-05-01

Brief Summary

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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

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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.

Conditions

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Constipation - Functional

Keywords

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Action Plan Adherence Pediatrics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Control group (standard of care) compared to Intervention group (standard of care plus constipation action plan)
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
Packet of information containing Standard of Care education materials and {Action Plan or No Action Plan} are prepared prior to enrollment; all participants get unlabeled packet without prior knowledge of participant or investigator or care provider.

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Constipation Action Plan

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nemours Children's Clinic

OTHER

Sponsor Role lead

Responsible Party

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Matthew Di Guglielmo

Clinical Associate Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Matthew Di Guglielmo, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Nemours

Locations

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Alfred I. duPont Hospital for Children

Wilmington, Delaware, United States

Site Status

Countries

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United States

References

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Palsson OS, Whitehead WE, van Tilburg MA, Chang L, Chey W, Crowell MD, Keefer L, Lembo AJ, Parkman HP, Rao SS, Sperber A, Spiegel B, Tack J, Vanner S, Walker LS, Whorwell P, Yang Y. Rome IV Diagnostic Questionnaires and Tables for Investigators and Clinicians. Gastroenterology. 2016 Feb 13:S0016-5085(16)00180-3. doi: 10.1053/j.gastro.2016.02.014. Online ahead of print.

Reference Type BACKGROUND
PMID: 27144634 (View on PubMed)

van den Berg MM, Benninga MA, Di Lorenzo C. Epidemiology of childhood constipation: a systematic review. Am J Gastroenterol. 2006 Oct;101(10):2401-9. doi: 10.1111/j.1572-0241.2006.00771.x.

Reference Type BACKGROUND
PMID: 17032205 (View on PubMed)

Steiner SA, Torres MR, Penna FJ, Gazzinelli BF, Corradi CG, Costa AS, Ribeiro IG, de Andrade EG, do Carmo Barros de Melo M. Chronic functional constipation in children: adherence and factors associated with drug treatment. J Pediatr Gastroenterol Nutr. 2014 May;58(5):598-602. doi: 10.1097/MPG.0000000000000255.

Reference Type BACKGROUND
PMID: 24345842 (View on PubMed)

Graves MM, Roberts MC, Rapoff M, Boyer A. The efficacy of adherence interventions for chronically ill children: a meta-analytic review. J Pediatr Psychol. 2010 May;35(4):368-82. doi: 10.1093/jpepsy/jsp072. Epub 2009 Aug 26.

Reference Type BACKGROUND
PMID: 19710248 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22471987 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21828166 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18049342 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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947325

Identifier Type: -

Identifier Source: org_study_id