Improving Bowel Cleansing With a Smart Phone Application
|ClinicalTrials.gov Identifier: NCT02303743|
Recruitment Status : Completed
First Posted : December 1, 2014
Results First Posted : January 13, 2015
Last Update Posted : October 14, 2016
|Condition or disease||Intervention/treatment||Phase|
|Cathartics Mobile Applications||Device: Smart Phone Application Device: Written instructions with visual aids||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||260 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Care Provider)|
|Official Title:||Improving the Quality of Colonoscopy Bowel Preparation Using a Smart Phone Application|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2014|
Active Comparator: Smart Phone Application (SPA) Group
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
Bowel preparation was evaluated using the Harefield Cleansing Scale (HCS). The scale was the primary outcome measure
Active Comparator: Control Group
Written instructions with visual aids explaining the procedure and when to begin self-administration of the bowel solution
Device: 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).
- Bowel Preparation Was Evaluated Using the Harefield Cleansing Scale (HCS). The Scale Was the Primary Outcome Measure [ Time Frame: Day 1 ]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.
- Patient Satisfaction Were Assessed With a Specific Questionnaire [ Time Frame: Day 1 ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02303743
|Principal Investigator:||Vicente Lorenzo-Zúñiga Garcíaa, M.D.; Ph.D.||Germans Trias i Pujol Hospital|