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

NCT ID: NCT04590105

Last Updated: 2020-10-19

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

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-15

Study Completion Date

2015-05-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pediatric ALL

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Subjects were randomly assigned via block randomization to receive either written or software-based prep instructions.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
Subjects were randomly assigned via block randomization to receive either written or software-based prep instructions. To eliminate bias, the four grading gastroenterologists who judged the quality of the subject's cleanout did not know whether subjects had used written or app instructions.

Study Groups

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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.

Group Type EXPERIMENTAL

Smartphone App "SB Colonoscopy Prep"

Intervention Type DEVICE

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.

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.

Group Type ACTIVE_COMPARATOR

Written Instruction

Intervention Type OTHER

Written Instruction

Interventions

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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.

Intervention Type DEVICE

Written Instruction

Written Instruction

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

5 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Stony Brook University

OTHER

Sponsor Role lead

Responsible Party

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James Brief

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeffrey Morganstern, MD

Role: STUDY_DIRECTOR

Stony Brook University Hospital

References

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Pall H, Zacur GM, Kramer RE, Lirio RA, Manfredi M, Shah M, Stephen TC, Tucker N, Gibbons TE, Sahn B, McOmber M, Friedlander J, Quiros JA, Fishman DS, Mamula P. Bowel preparation for pediatric colonoscopy: report of the NASPGHAN endoscopy and procedures committee. J Pediatr Gastroenterol Nutr. 2014 Sep;59(3):409-16. doi: 10.1097/MPG.0000000000000447.

Reference Type BACKGROUND
PMID: 24897169 (View on PubMed)

Pillai A, Menon R, Oustecky D, Ahmad A. Educational Colonoscopy Video Enhances Bowel Preparation Quality and Comprehension in an Inner City Population. J Clin Gastroenterol. 2018 Jul;52(6):515-518. doi: 10.1097/MCG.0000000000000893.

Reference Type BACKGROUND
PMID: 28742732 (View on PubMed)

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Reference Type BACKGROUND
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Reference Type BACKGROUND
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Cook KA, Modena BD, Simon RA. Improvement in Asthma Control Using a Minimally Burdensome and Proactive Smartphone Application. J Allergy Clin Immunol Pract. 2016 Jul-Aug;4(4):730-737.e1. doi: 10.1016/j.jaip.2016.03.005. Epub 2016 Apr 20.

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Reference Type BACKGROUND
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Reference Type BACKGROUND
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Reference Type BACKGROUND
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Reference Type BACKGROUND
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Reference Type BACKGROUND
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Reference Type BACKGROUND
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Reference Type BACKGROUND
PMID: 28152012 (View on PubMed)

Brief J, Chawla A, Lerner D, Vitola B, Woroniecki R, Morganstern J. The Impact of a Smartphone App on the Quality of Pediatric Colonoscopy Preparations: Randomized Controlled Trial. JMIR Pediatr Parent. 2020 Nov 10;3(2):e18174. doi: 10.2196/18174.

Reference Type DERIVED
PMID: 33170131 (View on PubMed)

Other Identifiers

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1132702

Identifier Type: -

Identifier Source: org_study_id

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