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Improving Bowel Cleansing With a Smart Phone Application

V

Vicente Lorenzo-Zúñiga García

Status and phase

Completed
Phase 4

Conditions

Cathartics
Mobile Applications

Treatments

Device: Smart Phone Application
Device: Written instructions with visual aids

Study type

Interventional

Funder types

Other

Identifiers

NCT02303743
CEI071114

Details and patient eligibility

About

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.

Full 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.

Enrollment

260 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Elective colonoscopy
  • Owners of a smartphone

Exclusion criteria

  • No owners of a smartphone

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

260 participants in 2 patient groups

Smart Phone Application (SPA) Group
Active Comparator group
Description:
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.
Treatment:
Device: Smart Phone Application
Control Group
Active Comparator group
Description:
Written instructions with visual aids explaining the procedure and when to begin self-administration of the bowel solution
Treatment:
Device: Written instructions with visual aids

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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