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

Pediatric ALL Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04590105
• Other study ID #: 1132702
• Status: Completed
• Phase: N/A
• Start date: November 15, 2014
• Est. completion date: May 1, 2015

Study information

• Verified date: October 2020
• Source: Stony Brook University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: May 1, 2015
• Est. primary completion date: May 1, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pediatric ALL

Intervention

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.

Other:
• Written Instruction
Written Instruction

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Stony Brook University

References & Publications (14)

Badawy SM, Kuhns LM. Economic Evaluation of Text-Messaging and Smartphone-Based Interventions to Improve Medication Adherence in Adolescents with Chronic Health Conditions: A Systematic Review. JMIR Mhealth Uhealth. 2016 Oct 25;4(4):e121. — View Citation

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. — View Citation

Hayat U, Lee PJ, Lopez R, Vargo JJ, Rizk MK. Online Educational Video Improves Bowel Preparation and Reduces the Need for Repeat Colonoscopy Within Three Years. Am J Med. 2016 Nov;129(11):1219.e1-1219.e9. doi: 10.1016/j.amjmed.2016.06.011. Epub 2016 Jul 6. — View Citation

Iacoviello BM, Steinerman JR, Klein DB, Silver TL, Berger AG, Luo SX, Schork NJ. Clickotine, A Personalized Smartphone App for Smoking Cessation: Initial Evaluation. JMIR Mhealth Uhealth. 2017 Apr 25;5(4):e56. doi: 10.2196/mhealth.7226. — View Citation

Iribarren SJ, Cato K, Falzon L, Stone PW. What is the economic evidence for mHealth? A systematic review of economic evaluations of mHealth solutions. PLoS One. 2017 Feb 2;12(2):e0170581. doi: 10.1371/journal.pone.0170581. eCollection 2017. Review. — View Citation

Kang X, Zhao L, Leung F, Luo H, Wang L, Wu J, Guo X, Wang X, Zhang L, Hui N, Tao Q, Jia H, Liu Z, Chen Z, Liu J, Wu K, Fan D, Pan Y, Guo X. Delivery of Instructions via Mobile Social Media App Increases Quality of Bowel Preparation. Clin Gastroenterol Hepatol. 2016 Mar;14(3):429-435.e3. doi: 10.1016/j.cgh.2015.09.038. Epub 2015 Oct 20. — View Citation

Lorenzo-Zúñiga V, Moreno de Vega V, Marín I, Barberá M, Boix J. Improving the quality of colonoscopy bowel preparation using a smart phone application: a randomized trial. Dig Endosc. 2015 Jul;27(5):590-5. doi: 10.1111/den.12467. Epub 2015 Mar 20. — View Citation

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. Review. — View Citation

Park JS, Kim MS, Kim H, Kim SI, Shin CH, Lee HJ, Lee WS, Moon S. A randomized controlled trial of an educational video to improve quality of bowel preparation for colonoscopy. BMC Gastroenterol. 2016 Jun 17;16(1):64. doi: 10.1186/s12876-016-0476-6. — View Citation

Perski O, Blandford A, Ubhi HK, West R, Michie S. Smokers' and drinkers' choice of smartphone applications and expectations of engagement: a think aloud and interview study. BMC Med Inform Decis Mak. 2017 Feb 28;17(1):25. doi: 10.1186/s12911-017-0422-8. — View Citation

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. — View Citation

Sagawa T, Sato K, Tomizawa T, Mizuide M, Yasuoka H, Shimoyama Y, Kuribayashi S, Kakizaki S, Kawamura O, Kusano M, Yamada M. A prospective randomized controlled trial of AJG522 versus standard PEG+E as bowel preparation for colonoscopy. Biomed Res Int. 2015;2015:521756. doi: 10.1155/2015/521756. Epub 2015 Jan 22. — View Citation

Ting TV, Kudalkar D, Nelson S, Cortina S, Pendl J, Budhani S, Neville J, Taylor J, Huggins J, Drotar D, Brunner HI. Usefulness of cellular text messaging for improving adherence among adolescents and young adults with systemic lupus erythematosus. J Rheumatol. 2012 Jan;39(1):174-9. doi: 10.3899/jrheum.110771. Epub 2011 Nov 15. — View Citation

Voiosu A, Tantau A, Garbulet C, Tantau M, Mateescu B, Baicus C, Voiosu R, Voiosu T. Factors affecting colonoscopy comfort and compliance: a questionnaire based multicenter study. Rom J Intern Med. 2014;52(3):151-7. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smartphone application use was associated with increased number of "excellent" colonoscopy preps.	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	The difference in the number of calls to the gastroenterology service between app users and controls.	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
Secondary	The difference between app users and controls regarding patient arrival time.	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
Secondary	The significant difference between app users and controls regarding patient knowledge about the procedure.	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