Improving Bowel Cleansing With a Smart Phone Application

Mobile Applications Clinical Trial

Official title:

Improving the Quality of Colonoscopy Bowel Preparation Using a Smart Phone Application

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02303743
• Other study ID #: CEI071114
• Status: Completed
• Phase: Phase 4
• First received: November 24, 2014
• Last updated: October 13, 2016
• Start date: January 2014
• Est. completion date: June 2014

Study information

• Verified date: January 2015
• Source: Germans Trias i Pujol Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

Description:

Background: 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.

Methods: The investigators have performed a prospective, endoscopist-blinded, randomized, controlled trial. The investigators have enrolled 260 outpatients owners of a smartphone. Patients were randomly allocated to two different protocols: instructions provided by SPA (SPA group; n=108) or written instructions with visual aids (control group; n=152). All procedures were performed in afternoon time and patients received the same purgative regimen (2-L PEG solution plus ascorbic acid), in a full-dose same-day regimen. The day before colonoscopy (Baseline), patients initiated low fiber diet. The study was designed to detect an improvement in quality of bowel preparation using the Harefield Cleansing Scale (HCS) scale. The effect of protocol on patient satisfaction was assessed with a specific questionnaire at time of the colonoscopy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Elective colonoscopy

• Owners of a smartphone

Exclusion Criteria:

• No owners of a smartphone

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cathartics
• Mobile Applications

Intervention

Device:
• Smart Phone Application
Bowel preparation was evaluated using the Harefield Cleansing Scale (HCS). The scale was the primary outcome measure
• Written instructions with visual aids
written instructions with visual aids explaining the procedure and when to begin self-administration of the bowel solution (control group).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Vicente Lorenzo-Zúñiga García

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Patient Satisfaction Were Assessed With a Specific Questionnaire	Patient satisfaction were assessed with a specific questionnaire before colonoscopy. Patients were asked if they used the application and their satisfaction with the app. Again, the endoscopist was blinded to the answers. The items read as follows: (1) "Do you have experience with a previous colonoscopy?"; (2) "Have you used the phone application?"; (3) "How easy was the preparation for colonoscopy?"; (4) "Which is your level of satisfaction with the bowel preparation?"; (5) "Would you like to repeat the same preparation in the future?"; (6) "Did you have any difficulty with the preparation?". Patient responses to the questionnaire were categorical (yes or no; questions 1, 2, 5, and 6) or numerical scale answers (0 to 10), from very difficult or very bad (0 or close to 0) to very easy or very good (10 or close to 10) (items 3 and 4).	Day 1	No

External Links

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