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Adherence/Outcomes After Use of Constipation Action Plan

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ClinicalTrials.gov Identifier: NCT03821532
Recruitment Status : Completed
First Posted : January 29, 2019
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
Matthew Di Guglielmo, Nemours Children's Clinic

Tracking Information
First Submitted Date  ICMJE December 15, 2018
First Posted Date  ICMJE January 29, 2019
Last Update Posted Date January 31, 2019
Actual Study Start Date  ICMJE September 13, 2016
Actual Primary Completion Date February 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 29, 2019)
  • 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
  • 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
  • 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
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 27, 2019)
  • Compliance Questionnaire [ Time Frame: 0 months ]
    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 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
  • 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
  • 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 29, 2019)
  • Symptoms [ Time Frame: At screening ]
    Number of participants with positive constipation symptoms using ROME IV Criteria
  • Symptoms [ Time Frame: 1 Month ]
    Number of participants with positive constipation symptoms using ROME IV Criteria
  • Symptoms [ Time Frame: 3 Month ]
    Number of participants with positive constipation symptoms using ROME IV Criteria
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 27, 2019)
  • Symptoms [ Time Frame: 0 months ]
    Number of participants with positive constipation symptoms using ROME IV Criteria
  • Symptoms [ Time Frame: 1 Month ]
    Number of participants with positive constipation symptoms using ROME IV Criteria
  • Symptoms [ Time Frame: 3 Month ]
    Number of participants with positive constipation symptoms using ROME IV Criteria
  • 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.
  • 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.
  • Caregiver Literacy [ Time Frame: 0 months ]
    Assess literacy level for caregivers by administering the Short-Form Rapid Assessment of Adult Literacy in Medicine.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adherence/Outcomes After Use of Constipation Action Plan
Official Title  ICMJE Evaluation of Adherence and Outcomes in Children With Functional Constipation After Implementing a Constipation Action Plan
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Control group (standard of care) compared to Intervention group (standard of care plus constipation action plan)
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:
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.
Primary Purpose: Treatment
Condition  ICMJE Constipation - Functional
Intervention  ICMJE Other: 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.
Study Arms  ICMJE
  • No Intervention: 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.
  • Experimental: 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.
    Intervention: Other: Constipation Action Plan
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 27, 2019)
25
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 1, 2018
Actual Primary Completion Date February 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 8 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03821532
Other Study ID Numbers  ICMJE 947325
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Matthew Di Guglielmo, Nemours Children's Clinic
Study Sponsor  ICMJE Nemours Children's Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Matthew Di Guglielmo, MD PhD Nemours
PRS Account Nemours Children's Clinic
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP