The Impact of a Smartphone App on the Quality of Pediatric Colonoscopy Preparations

October 10, 2020 updated by: James Brief, Stony Brook University
The investigators developed a smartphone app that guides pediatric patients and their families through colonoscopy prep in an attempt to see if an app could improve the colonoscopy process.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators created a smartphone app designed for pediatric patients and their families that informs patients about their colonoscopy procedure, alerts them when to take their medications throughout the hours-long colonoscopy prep process and tells them when to arrive to the endoscopy suite. The investigators designed a study to determine if this app will yield improved colonoscopy cleanouts, better patient understanding of the procedure, fewer calls to the GI service and more punctual arrival times to the endoscopy suite compared to patients who receive written instructions that do not actively interact with the patient before, during or after their colonoscopy prep.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

- Aged 5-18 years scheduled to undergo a diagnostic and/or therapeutic colonoscopy

Exclusion Criteria:

  • Patients who had undergone a colonoscopy within the past one year
  • Patients admitted for a nasogastric (NG) cleanout
  • Patients requiring colonoscopy preparation medication other than Polyethylene Glycol
  • Patients with poor understanding of English.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: App Subject
Users who were assigned to use a smartphone app downloaded a free app from the iOS App or Google Play stores titled "SB Colonoscopy Prep." The app informed subjects about their colonoscopy procedure, alerts them when to take their medications throughout the hours-long colonoscopy prep process and tells them when to arrive to the endoscopy suite.
Device: Smartphone App "SB Colonoscopy Prep"
We created a smartphone app that informs patients about their colonoscopy procedure, alerts them when to take their medications throughout the hours-long colonoscopy prep process and tells them when to arrive to the endoscopy suite.
Active Comparator: Written Instruction Subjects
Subjects in the control group were given a three-page document that described the procedure and instructed users on how to take the preparation medications. The written instructions had a list of frequently asked questions about colonoscopies and the URL of a website where users could view the animated video that was included in the app. The written instructions also contained the time and date of the procedure. All subjects were instructed to arrive one hour before their scheduled procedure.
Other: Written Instruction
Written Instruction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Smartphone application use was associated with increased number of "excellent" colonoscopy preps.
Time Frame: Each subject was assessed from the time they were scheduled for their colonoscopy to the day of their procedure, up to three months for subjects. Subjects were scored on their colonoscopies immediately following the procedure once the patient was stable
Prep quality was measured with the validated Boston Scoring Scale. A score of 0, 1, 2 or 3 is given to the right, transverse and left colon based on the amount and consistency of stool visualized as well as the ease or difficulty of guiding endoscopic instrumentation during a colonoscopy. Higher scores indicate a cleaner colon and as per Lai, a Boston Score of 7 or above indicates an "excellent" prep. To eliminate bias, the four grading gastroenterologists did not know whether subjects had used written or app instructions.
Each subject was assessed from the time they were scheduled for their colonoscopy to the day of their procedure, up to three months for subjects. Subjects were scored on their colonoscopies immediately following the procedure once the patient was stable

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The difference in the number of calls to the gastroenterology service between app users and controls.
Time Frame: Each subject was assessed from the time they were scheduled for their colonoscopy to the day of their procedure, up to three months for subjects
Calls to the GI service were recorded by the GI staff.
Each subject was assessed from the time they were scheduled for their colonoscopy to the day of their procedure, up to three months for subjects
The difference between app users and controls regarding patient arrival time.
Time Frame: Each subject was assessed from the time they were scheduled for their colonoscopy to the day of their procedure, up to three months for subjects
Patient arrival time was taken from the patients arrival time in the endoscopy suite.
Each subject was assessed from the time they were scheduled for their colonoscopy to the day of their procedure, up to three months for subjects
The significant difference between app users and controls regarding patient knowledge about the procedure.
Time Frame: Each subject was assessed from the time they were scheduled for their colonoscopy to the day of their procedure, up to three months for subjects
A questionnaire with validated questions determined whether subjects improvement their knowledge before and after receiving colonoscopy information.
Each subject was assessed from the time they were scheduled for their colonoscopy to the day of their procedure, up to three months for subjects

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stony Brook University

Investigators

  • Study Director: Jeffrey Morganstern, MD, Stony Brook University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2014

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

September 28, 2020

First Submitted That Met QC Criteria

October 10, 2020

First Posted (Actual)

October 19, 2020

Study Record Updates

Last Update Posted (Actual)

October 19, 2020

Last Update Submitted That Met QC Criteria

October 10, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 1132702

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

I am happy to share all data in whatever way is easiest for everyone

IPD Sharing Time Frame

Immediately

IPD Sharing Access Criteria

Email request

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pediatric ALL

Clinical Trials on Smartphone App "SB Colonoscopy Prep"

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Algeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe