Improving Bowel Cleansing With a Smart Phone Application

NCT02303743 | Completed Phase 4 Results

• 1 other identifier: CEI071114
• Study Type: interventional
• Target: 260
• Locations: 0 countries
• Sites: N/A

Brief Summary

Getting ready for a colonoscopy is difficult and involves a lot of steps. The information given to patients is very important to adherence to treatment. The investigators have created a novel smart phone application (SPA) aimed to increased bowel preparation quality and patient satisfaction, using different educational tools.

Conditions

Cathartics; Mobile Applications

Keywords

Bowel preparation; colonoscopy; Smartphone application

Outcome Measures

Primary Outcomes (1)

• Bowel Preparation Was Evaluated Using the Harefield Cleansing Scale (HCS). The Scale Was the Primary Outcome Measure

  The quality of bowel cleansing is evaluated after colonoscopy (Day 1). Baseline the patients initiated low fiber diet in the 24 hours prior to colonoscopy. The HCS uses a 5-point qualitative scale in 5 separate colon segments. HCS is the sum of 5 segments, ranging from 0 (worst possible outcome) to 20 (best possible outcome). Global score assesses the quality of bowel cleansing: Successful (A or B) / unsuccessful (C or D). A: All segments scored 3 or 4; B: One or more segments scored 2; C: One or more segments scored 1; and D: One or more segments scored 0.

  Day 1

Secondary Outcomes (1)

• Patient Satisfaction Were Assessed With a Specific Questionnaire

  Day 1

Study Arms (2)

Smart Phone Application (SPA) Group

ACTIVE COMPARATOR

Patients assigned to SPA group were instructed on how to free-download the application onto their smartphone. Each patient enters the date and time of his colonoscopy and timed alerts appeared on the phone to alert the patient of the next step in bowel preparation. In addition to the alerts, the app assists in bowel preparation by explaining the procedure, providing tips, examples of low fiber diet, and displaying pictures of preparation quality and educational video to explain how to prepare the purgative solution.Finally, the patient can obtain a checklist to confirm all steps.

Device: Smart Phone Application

Control Group

ACTIVE COMPARATOR

Written instructions with visual aids explaining the procedure and when to begin self-administration of the bowel solution

Device: Written instructions with visual aids

Interventions

Smart Phone Application DEVICE

Bowel preparation was evaluated using the Harefield Cleansing Scale (HCS). The scale was the primary outcome measure

Smart Phone Application (SPA) Group

Written instructions with visual aids DEVICE

written instructions with visual aids explaining the procedure and when to begin self-administration of the bowel solution (control group).

Control Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective colonoscopy
• Owners of a smartphone

You may not qualify if:

• No owners of a smartphone

Sponsors & Collaborators

• Vicente Lorenzo-Zúñiga García: lead

Related Publications (5)

• Harewood GC, Sharma VK, de Garmo P. Impact of colonoscopy preparation quality on detection of suspected colonic neoplasia. Gastrointest Endosc. 2003 Jul;58(1):76-9. doi: 10.1067/mge.2003.294.

  PMID: 12838225 BACKGROUND

• Froehlich F, Wietlisbach V, Gonvers JJ, Burnand B, Vader JP. Impact of colonic cleansing on quality and diagnostic yield of colonoscopy: the European Panel of Appropriateness of Gastrointestinal Endoscopy European multicenter study. Gastrointest Endosc. 2005 Mar;61(3):378-84. doi: 10.1016/s0016-5107(04)02776-2.

  PMID: 15758907 BACKGROUND

• Spiegel BM, Talley J, Shekelle P, Agarwal N, Snyder B, Bolus R, Kurzbard N, Chan M, Ho A, Kaneshiro M, Cordasco K, Cohen H. Development and validation of a novel patient educational booklet to enhance colonoscopy preparation. Am J Gastroenterol. 2011 May;106(5):875-83. doi: 10.1038/ajg.2011.75. Epub 2011 Apr 12.

  PMID: 21483463 BACKGROUND

• Tae JW, Lee JC, Hong SJ, Han JP, Lee YH, Chung JH, Yoon HG, Ko BM, Cho JY, Lee JS, Lee MS. Impact of patient education with cartoon visual aids on the quality of bowel preparation for colonoscopy. Gastrointest Endosc. 2012 Oct;76(4):804-11. doi: 10.1016/j.gie.2012.05.026. Epub 2012 Jul 27.

  PMID: 22840295 BACKGROUND

• Prakash SR, Verma S, McGowan J, Smith BE, Shroff A, Gibson GH, Cheng M, Lowe Ii D, Gopal K, Mohanty SR. Improving the quality of colonoscopy bowel preparation using an educational video. Can J Gastroenterol. 2013 Dec;27(12):696-700. doi: 10.1155/2013/292636.

  PMID: 24340313 BACKGROUND

Related Links

• Moviprep: ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE

Results Point of Contact

• Title: Dr. Vicente Lorenzo-Zúñiga García
• Organization: Hospital Germans Trias i Pujol

vlorenzo.germanstrias@gencat.cat

+34-934978866

Study Officials

• Vicente Lorenzo-Zúñiga Garcíaa, M.D.; Ph.D.

  Germans Trias i Pujol Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D.; Ph.D.

Study Record Dates

• First Submitted: November 24, 2014
• First Posted: December 1, 2014
• Study Start: January 1, 2014
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: October 14, 2016
• Results First Posted: January 13, 2015

Record last verified: 2015-01