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Adherence, MedicationNCT04614935

Adherence and Outcomes in Functional Constipation With a Constipation Action Plan

A study testing Action Plan in people with Adherence, Medication and Functional Constipation, run by University of Alabama at Birmingham at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

We will be assessing for improvement in reported symptoms as well as reported quality of life in pediatric patients with functional constipation using a constipation action plan and an adherence log. Read more about this study

Who is it for?
Ages 4 to 8 yearsHealthy volunteers can take part
What is being tested?
Action Plan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteUnited States
Study dates
1 Nov 2020to 1 Mar 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 8 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Have been potty-trained for stool at some point
  • Chief complaint constipation or encopresis
  • Meets Rome IV criteria for functional constipation

Who cannot join

  • Preexisting diagnoses of autism, cerebral palsy, developmental delay, and/or thyroid disease
  • Prior gastrointestinal surgery
  • Presence of "red flag" symptoms for organic etiology:
  • Passage of meconium >48 hours after birth in a term newborn
  • Family history of Hirschsprung's Disease
  • "Ribbon" stools
  • Blood in stools (in absence of anal fissure)
  • Coexisting diagnosis of malnutrition, bilious vomiting, abnormal anal positioning, absent anal reflex, decreased lower extremity strength/tone, sacral dimple, and/or tuft of hair on spine

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UAB/COA

    Birmingham, Alabama, 35233

Other trials in United States

About this study

We will be assessing for improvement in reported symptoms as well as reported quality of life in pediatric patients with functional constipation using a constipation action plan and an adherence log.

Read the detailed description

Functional Constipation is one of the most common chief complaints for both the general pediatrician and the pediatric gastroenterologist. Treatment for this disorder is multifactorial, and usually involves different medications combined with behavioral techniques, depending on the severity of the underlying constipation. Studies have shown that medication compliance is one of the strongest predictors of successful treatment, but maintaining good medication adherence at home is uncommon for a variety of reasons. In this study, the investigators are aiming to improve home medication adherence for functional constipation to improve treatment outcomes. The investigators will be administering surveys for all enrolled participants to determine the child's and family's overall quality of life related to functional constipation. For the treatment group, the investigators will be providing tools to help with medication adherence. This will include a daily log to determine symptom severity, along with an "action plan" with instructions for how to adjust medicines, if necessary, depending on symptoms. By empowering families with this knowledge and medication roadmap, the investigators hypothesize that there will be overall symptomatic improvement in functional constipation, along with improved quality of life for both the patient and their family. The investigators will measure adherence (by reviewing symptom log and action plan at 2-month and 4-month follow up appointments.) with the treatment group. The investigators will be measuring overall quality of life and symptom improvement using a validated pediatric constipation quality of life survey (PedsQL GI) with both the treatment group and the control group at follow up appointments.

Being tested
Action Plan
Medical subject headings
Medication Adherence, Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Action PlanBehavioural

    Also called Adherence Log

    See arm description.

Study groups in NCT04614935
Study groupRoleWhat they receive
Standard of CareNo interventionPediatric patients with functional constipation who are treated with medications and/or behavioral therapies as they would be if they were not enrolled in the study. In addition to standard of care treatment, these families will fill out a brief quality of life survey.
Action PlanExperimentalPediatric patients with functional constipation who are treated with standard of care medications and/or behavioral therapies and are also provided with a medication adherence log along with a constipation action plan. These families will also fill out a brief quality of life survey.
Receives: Behavioral: Action Plan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Medication and behavioral modification adherence

    Calendar where families place a colored sticker (green, yellow, or red, depending on how symptoms correlate to the constipation action plan), measured as a ratio of total number of days logged/total number of days possible to log. Adherence log will be reviewed at each follow appointment (2 month and 4 month).

    Measured: 4 months

Secondary outcomes (1)

  1. Quality of Life survey results

    Parent report of child constipation symptoms using validated Pediatric Quality of Life (PedsQL) survey for functional constipation in the past month, using the Likert scale responses, with raw scores transformed to a 0 to 100 scale, with 0 being severe impairment and 100 being no impairment. This survey will be given on initial visit and repeated at 2 month and 4 month follow up visits.

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2020
  2. Study start1 Nov 2020
  3. Primary completion31 Dec 2021
  4. Study completion1 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04614935
Sponsor's protocol ID
IRB-300005480
Status last verified
Apr 2022
First submitted
28 Oct 2020
Last updated
15 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Felt B, Wise CG, Olson A, Kochhar P, Marcus S, Coran A. Guideline for the management of pediatric idiopathic constipation and soiling. Multidisciplinary team from the University of Michigan Medical Center in Ann Arbor. Arch Pediatr Adolesc Med. 1999 Apr;153(4):380-5. doi: 10.1001/archpedi.153.4.380.

    PubMed 10201721

  • Rasquin A, Di Lorenzo C, Forbes D, Guiraldes E, Hyams JS, Staiano A, Walker LS. Childhood functional gastrointestinal disorders: child/adolescent. Gastroenterology. 2006 Apr;130(5):1527-37. doi: 10.1053/j.gastro.2005.08.063.

    PubMed 16678566

  • Koppen IJN, van Wassenaer EA, Barendsen RW, Brand PL, Benninga MA. Adherence to Polyethylene Glycol Treatment in Children with Functional Constipation Is Associated with Parental Illness Perceptions, Satisfaction with Treatment, and Perceived Treatment Convenience. J Pediatr. 2018 Aug;199:132-139.e1. doi: 10.1016/j.jpeds.2018.03.066. Epub 2018 May 10.

    PubMed 29754864

  • 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.

    PubMed 24345842

  • Varni JW, Bendo CB, Denham J, Shulman RJ, Self MM, Neigut DA, Nurko S, Patel AS, Franciosi JP, Saps M, Yeckes A, Langseder A, Saeed S, Pohl JF. PedsQL Gastrointestinal Symptoms Scales and Gastrointestinal Worry Scales in pediatric patients with functional and organic gastrointestinal diseases in comparison to healthy controls. Qual Life Res. 2015 Feb;24(2):363-78. doi: 10.1007/s11136-014-0781-x. Epub 2014 Aug 23.

    PubMed 25148757

Questions about this trial

What is this clinical trial studying?

A study testing Action Plan in people with Adherence, Medication and Functional Constipation, run by University of Alabama at Birmingham at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Medication and behavioral modification adherence (time frame: 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04614935, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2022.

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