Clinical trial NCT02303743: Improving Bowel Cleansing With a Smart Phone Application
Official title: Improving the Quality of Colonoscopy Bowel Preparation Using a Smart Phone Application
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cathartics
Mobile Applications
Keywords: Bowel preparation; colonoscopy; Smartphone application
Lead sponsor: Germans Trias i Pujol Hospital
Sponsor class: OTHER
First posted: 2014-12-01
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Elective colonoscopy
* Owners of a smartphone

Exclusion Criteria:

* No owners of a smartphone

Primary outcomes:
measure: Bowel Preparation Was Evaluated Using the Harefield Cleansing Scale (HCS). The Scale Was the Primary Outcome Measure
timeFrame: Day 1
Secondary outcomes:
measure: Patient Satisfaction Were Assessed With a Specific Questionnaire
timeFrame: Day 1
Other outcomes:
Locations:
Study officials:
affiliation: Germans Trias i Pujol Hospital
name: Vicente Lorenzo-Zúñiga Garcíaa, M.D.; Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1067/mge.2003.294.
citation: 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.
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.
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.
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. doi: 10.1155/2013/292636.